Trial Outcomes & Findings for A Study of an Antibiotic Implant in General Surgical Subjects at Higher Risk for Surgical Wound Infection (NCT NCT00600925)

Last Updated: 2021-09-24

Results Overview

Primarily, efficacy will be evaluated by a comparison between the 2 study groups of the incidence of surgical wound infections (involving the laparotomy incision) that occur within the period from surgery through postop day 60.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

602 participants

Primary outcome timeframe

assessed at Postop Day 1, 2, 3, 7, 30 & 60

Results posted on

2021-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Gentamicin Group Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy	Control Standard of care, ie, no gentamicin-collagen sponge.
Overall Study STARTED	300	302
Overall Study COMPLETED	300	302
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of an Antibiotic Implant in General Surgical Subjects at Higher Risk for Surgical Wound Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gentamicin Group Group n=300 Participants Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy	Control Group n=302 Participants Standard of care, ie, no gentamicin-collagen sponge.	Total n=602 Participants Total of all reporting groups
Age, Continuous	56.9 Years STANDARD_DEVIATION 15.36 • n=99 Participants	56.5 Years STANDARD_DEVIATION 15.81 • n=107 Participants	56.7 Years STANDARD_DEVIATION 15.57 • n=206 Participants
Sex: Female, Male Female	181 Participants n=99 Participants	158 Participants n=107 Participants	339 Participants n=206 Participants
Sex: Female, Male Male	119 Participants n=99 Participants	144 Participants n=107 Participants	263 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants	6 Participants n=107 Participants	8 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Black or African American	22 Participants n=99 Participants	19 Participants n=107 Participants	41 Participants n=206 Participants
Race (NIH/OMB) White	272 Participants n=99 Participants	273 Participants n=107 Participants	545 Participants n=206 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants	4 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: assessed at Postop Day 1, 2, 3, 7, 30 & 60

Population: ITT population

Outcome measures

Outcome measures
Measure	Gentamicin Group n=300 Participants Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy	Control n=302 Participants Standard of care, ie, no gentamicin-collagen sponge.
Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 60	90 Participants	63 Participants

SECONDARY outcome

Timeframe: assessed at Postop Day 1, 2, 3, 7, 30 & 60

Number of Participants who had superficial incisional surgical wound infection, based on CDC criteria adjudicated by an independent blinded committee

Outcome measures

Outcome measures
Measure	Gentamicin Group n=300 Participants Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy	Control n=302 Participants Standard of care, ie, no gentamicin-collagen sponge.
Number of Participants Who Had Superficial Incisional Surgical Wound Infection	61 Participants	41 Participants

SECONDARY outcome

Timeframe: assessed at Postop Day 1, 2, 3, 7, 30 & 60

Population: ITT population

The proportion of subjects who had deep incisional SWI, based on Centers for Disease Control and Prevention (CDC) criteria adjudicated by an independent blinded committee

Outcome measures

Outcome measures
Measure	Gentamicin Group n=300 Participants Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy	Control n=302 Participants Standard of care, ie, no gentamicin-collagen sponge.
The Effect of the Gentamicin-collagen Sponge on the Proportion of Patients With Deep Incisional Surgical Wound Infection	25 Participants	18 Participants

SECONDARY outcome

Timeframe: Days 3, 4, 5, 6, and 7 (or discharge if earlier) and then questionnaire/phone call on post-operative Days 30 and 60.

Population: ITT population

Mean (SD) ASEPSIS Score Through 60 Days Postoperatively - brief assessment of surgical wound on post-operative Days 3, 4, 5, 6, and 7 (or discharge if earlier) and then questionnaire/phone call on post-operative Days 30 and 60. Score from each time point is added up and the mean score is reported. Used to compare antibiotic regimens for their effectiveness in preventing or treating wound sepsis, well-defined criteria for outcome are needed. A method of assessing wound healing has been devised that defines carefully the characteristics to be considered and how they are to be awarded points. Objective criteria are also included in the assessment. Points are given for the need for Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay (ASEPSIS). The higher the points the worse outcome. Maximum Points would be 60. Minimum points would be 0

Outcome measures

Outcome measures
Measure	Gentamicin Group n=299 Participants Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy	Control n=299 Participants Standard of care, ie, no gentamicin-collagen sponge.
The Effect of the Gentamicin-collagen Sponge on the ASEPSIS Score	6.1 score on a scale Standard Deviation 10.38	5.2 score on a scale Standard Deviation 10.99

SECONDARY outcome

Timeframe: Immediate post operative period

Population: ITT population

Outcome measures

Outcome measures
Measure	Gentamicin Group n=300 Participants Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy	Control n=302 Participants Standard of care, ie, no gentamicin-collagen sponge.
The Effect of the Gentamicin-collagen Sponge on Length of Hospital Stay Postoperatively.	7.5 days Standard Deviation 6.19	7.3 days Standard Deviation 5.42

SECONDARY outcome

Timeframe: Through 60 days after surgery

Population: ITT population

The effect of the gentamicin-collagen sponge on rehospitalization for surgical wound infection.

Outcome measures

Outcome measures
Measure	Gentamicin Group n=300 Participants Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy	Control n=302 Participants Standard of care, ie, no gentamicin-collagen sponge.
Number of Participants Who Were Rehospitalized for Surgical Wound Infection Within 60 Days Post-operatively	21 Participants	13 Participants

Adverse Events

Gentamicin Group Group

Serious events: 114 serious events

Other events: 294 other events

Deaths: 1 deaths

Control Group

Serious events: 101 serious events

Other events: 302 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management

Innocoll

Phone: 484-406-5211

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Gentamicin Group Group n=296 participants at risk Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy	Control Group n=306 participants at risk Standard of care, ie, no gentamicin-collagen sponge.
Blood and lymphatic system disorders Anaemia	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Blood and lymphatic system disorders Pernicious anaemia	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Blood and lymphatic system disorders Splenic infarcation	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Cardiac disorders Acute myocardial infarction	0.00% 0/296 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.65% 2/306 • Number of events 2 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Cardiac disorders Atrial Fibrillation	1.0% 3/296 • Number of events 3 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Cardiac disorders Myocardial infarction	0.00% 0/296 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Cardiac disorders Supraventricular tachycardia	0.00% 0/296 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Cardiac disorders Tachycardia	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Cardiac disorders Myocardial ischaemia	0.00% 0/296 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Abdominal pain	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.65% 2/306 • Number of events 2 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Colonic fistula	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Crohn's disease	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Diarrhoea	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Duodenal ulcer perforation	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Enterocutaneous fistula	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Faecal volume increased	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.65% 2/306 • Number of events 2 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Faecaloma	0.00% 0/296 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Gastric hypomotility	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.68% 2/296 • Number of events 2 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Gastrointestinal hypomotility	0.00% 0/296 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Gastrointestinal motility disorder	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Ileal perforation	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Inguinal hernia strangulated	0.00% 0/296 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Intestinal obstruction	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Intestinal perforation	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Intra-abdominal haematoma	0.00% 0/296 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.65% 2/306 • Number of events 2 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Large intestine perforation	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Mesenteric panniculitis	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Nausea	0.00% 0/296 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.65% 2/306 • Number of events 2 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Peritonitis	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Proctalgia	0.68% 2/296 • Number of events 2 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Rectal haemorrhage	1.4% 4/296 • Number of events 4 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Reflux oesophagitis	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Small intestinal obstruction	2.7% 8/296 • Number of events 8 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	3.3% 10/306 • Number of events 10 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Vomiting	1.0% 3/296 • Number of events 3 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
General disorders Non-cardiac chest pain	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
General disorders Pyrexia	0.34% 1/296 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.00% 0/306 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
General disorders Hepatobiliary disorders	2.0% 6/296 • Number of events 6 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	0.33% 1/306 • Number of events 1 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.

Other adverse events
Measure	Gentamicin Group Group n=296 participants at risk Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin). gentamicin-collagen sponge dipped in saline: 2 gentamicin-collagen sponges inserted before closure of the laparotomy	Control Group n=306 participants at risk Standard of care, ie, no gentamicin-collagen sponge.
Blood and lymphatic system disorders Anaemia	23.6% 70/296 • Number of events 70 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	16.7% 51/306 • Number of events 51 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Blood and lymphatic system disorders Leukocytosis	5.7% 17/296 • Number of events 17 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	4.6% 14/306 • Number of events 14 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Cardiac disorders Tachycardia	15.5% 46/296 • Number of events 46 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	15.0% 46/306 • Number of events 46 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Abdominal Distension	23.6% 70/296 • Number of events 70 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	23.9% 73/306 • Number of events 73 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Abdominal pain	24.0% 71/296 • Number of events 71 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	26.5% 81/306 • Number of events 81 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Diarrhoea	7.8% 23/296 • Number of events 23 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	4.2% 13/306 • Number of events 13 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Nausea	56.4% 167/296 • Number of events 167 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	62.4% 191/306 • Number of events 191 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Gastrointestinal disorders Vomiting	33.1% 98/296 • Number of events 98 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	25.8% 79/306 • Number of events 79 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
General disorders Fatigue	5.4% 16/296 • Number of events 16 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	5.2% 16/306 • Number of events 16 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
General disorders Oedema Peripheral	6.1% 18/296 • Number of events 18 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	6.9% 21/306 • Number of events 21 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
General disorders Pyrexia	19.3% 57/296 • Number of events 57 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	19.3% 59/306 • Number of events 59 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Infections and infestations Post-operative Wound infection	15.9% 47/296 • Number of events 47 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	11.4% 35/306 • Number of events 35 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Infections and infestations Urinary Tract Infection	7.4% 22/296 • Number of events 22 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	10.5% 32/306 • Number of events 32 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Injury, poisoning and procedural complications Abdominal Wound Dehiscence	11.5% 34/296 • Number of events 34 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	5.6% 17/306 • Number of events 17 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Injury, poisoning and procedural complications Incision Site Pain	40.2% 119/296 • Number of events 119 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	39.9% 122/306 • Number of events 122 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Injury, poisoning and procedural complications Post procedural Discharge	19.3% 57/296 • Number of events 57 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	13.7% 42/306 • Number of events 42 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Injury, poisoning and procedural complications Post-operative Ileus	7.8% 23/296 • Number of events 23 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	10.1% 31/306 • Number of events 31 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Injury, poisoning and procedural complications Post-operative Wound Complication	11.1% 33/296 • Number of events 33 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	13.4% 41/306 • Number of events 41 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Injury, poisoning and procedural complications Procedural Pain	27.4% 81/296 • Number of events 81 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	25.2% 77/306 • Number of events 77 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Investigations Blood Glucose Increased	5.4% 16/296 • Number of events 16 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	5.9% 18/306 • Number of events 18 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Investigations Body Temperature Increased	8.1% 24/296 • Number of events 24 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	6.9% 21/306 • Number of events 21 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Investigations Breath Sounds Abnorma	8.8% 26/296 • Number of events 26 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	5.9% 18/306 • Number of events 18 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Investigations Urine Output Decreased	8.4% 25/296 • Number of events 25 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	6.2% 19/306 • Number of events 19 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Investigations White Blood Cell Count Increased	8.8% 26/296 • Number of events 26 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	5.9% 18/306 • Number of events 18 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Metabolism and nutrition disorders Decreased Appetite	6.1% 18/296 • Number of events 18 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	5.9% 18/306 • Number of events 18 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Metabolism and nutrition disorders Dehydration	5.4% 16/296 • Number of events 16 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	4.6% 14/306 • Number of events 14 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Metabolism and nutrition disorders Hyperglycaemia	7.1% 21/296 • Number of events 21 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	6.5% 20/306 • Number of events 20 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Metabolism and nutrition disorders Hypokalaemia	16.6% 49/296 • Number of events 49 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	14.7% 45/306 • Number of events 45 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Metabolism and nutrition disorders Hypomagnesaemia	11.8% 35/296 • Number of events 35 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	9.2% 28/306 • Number of events 28 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Musculoskeletal and connective tissue disorders Back Pain	5.1% 15/296 • Number of events 15 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	7.2% 22/306 • Number of events 22 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Nervous system disorders Dizziness	11.1% 33/296 • Number of events 33 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	10.8% 33/306 • Number of events 33 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Nervous system disorders Headache	5.4% 16/296 • Number of events 16 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	7.5% 23/306 • Number of events 23 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.1% 15/296 • Number of events 15 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	5.9% 18/306 • Number of events 18 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.
Skin and subcutaneous tissue disorders Pruritus	7.4% 22/296 • Number of events 22 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.	7.5% 23/306 • Number of events 23 • Subjects remained enrolled into the study until 60 days post-operatively The ITT population is analyzed as randomized, while the safety population is analyzed as treated. There were 4 patients who were randomized to the gentamicin group who were not treated with the sponge. The analyses based on the safety population includes the 302 patients randomized to placebo plus these additional 4 patients.