Trial Outcomes & Findings for Skin Prep to Reduce Postoperative Shoulder Infection (NCT NCT02510144)

Last Updated: 2020-02-11

Results Overview

Preoperative Cutibacterium acnes shoulder burden. Skin cultures of both shoulders were obtained via a detergent scrub technique the day of surgery at anterior, lateral, and posterior sites and the axilla.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

At time of surgery

Results posted on

2020-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Chlorhexidine A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens) Skin Prep Chlorhexidine: 3 day preoperative skin prep prior to surgery	Benzoyl Peroxide A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8) Skin Prep Benzoyl Peroxide: 3 day preoperative skin prep prior to surgery
Overall Study STARTED	39	41
Overall Study COMPLETED	39	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chlorhexidine n=39 Participants A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens) Skin Prep Chlorhexidine: 3 day preoperative skin prep prior to surgery	Benzoyl Peroxide n=41 Participants A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8) Skin Prep Benzoyl Peroxide: 3 day preoperative skin prep prior to surgery	Total n=80 Participants Total of all reporting groups
Age, Continuous	51 years n=39 Participants	51 years n=41 Participants	51 years n=80 Participants
Sex: Female, Male Female	20 Participants n=39 Participants	23 Participants n=41 Participants	43 Participants n=80 Participants
Sex: Female, Male Male	19 Participants n=39 Participants	18 Participants n=41 Participants	37 Participants n=80 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	39 participants n=39 Participants	41 participants n=41 Participants	80 participants n=80 Participants
BMI	30.2 kg/m^2 n=39 Participants	30.7 kg/m^2 n=41 Participants	30.5 kg/m^2 n=80 Participants
Active smokers	10 Participants n=39 Participants	13 Participants n=41 Participants	23 Participants n=80 Participants
Diabetes	8 Participants n=39 Participants	8 Participants n=41 Participants	16 Participants n=80 Participants
Arthroplasty cases	14 Participants n=39 Participants	13 Participants n=41 Participants	27 Participants n=80 Participants

PRIMARY outcome

Timeframe: At time of surgery

Population: 8 samples/skin cultures were obtained from each participant; 4 from each shoulder. The contralateral shoulder was the control.

Outcome measures

Outcome measures
Measure	Chlorhexidine n=156 skin cultures A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens) Skin Prep Chlorhexidine: 3 day preoperative skin prep prior to surgery	Benzoyl Peroxide n=164 skin cultures A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8) Skin Prep Benzoyl Peroxide: 3 day preoperative skin prep prior to surgery
Skin Swab and Culture With Colony Forming Units (CFUs) Intervention	39 negative skin cultures	51 negative skin cultures
Skin Swab and Culture With Colony Forming Units (CFUs) Control	35 negative skin cultures	22 negative skin cultures

SECONDARY outcome

Timeframe: At one year

Cultures were evaluated in our lab and also tested for hemolysis as a possible indicator of a more virulent strain in the literature.

Outcome measures

Outcome measures
Measure	Chlorhexidine n=39 Participants A preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens) Skin Prep Chlorhexidine: 3 day preoperative skin prep prior to surgery	Benzoyl Peroxide n=41 Participants A preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8) Skin Prep Benzoyl Peroxide: 3 day preoperative skin prep prior to surgery
Surgical Site Infection That Requires Antibiotics	0 Participants	0 Participants

Adverse Events

Chlorhexidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Benzoyl Peroxide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mohit Gilotra

University of Maryland Baltimore

Phone: (301) 502-4102

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place