Trial Outcomes & Findings for Antibiotic Irrigations for Intra-Abdominal Drains (NCT NCT03476941)
NCT ID: NCT03476941
Last Updated: 2026-09-03
Results Overview
Total duration of systemic antibiotics will be recorded from the start of the treatment until discontinuation by primary care team. This will be measured as days from diagnosis to when the antibiotic treatment gets interrupted. Duration of systemic antibiotics will be our primary outcome measurement. Duration of systemic antibiotics will be monitored as an indication of the effectiveness of the proposed intervention.
TERMINATED
PHASE2
2 participants
From initiation of systemic treatment until 1 month follow up
2026-09-03
Participant Flow
Participant milestones
| Measure |
Antibiotic Irrigation
The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum
Gentamicin Sulfate Inj 20mg/2ml vial for injection: Irrigate surgical drain with total amount of 5 mg in 10 ml volume twice/day for 7 days or until drain removal if less than 7 days of therapy.
Clindamycin phosphate 6 mg/1ml for injection: Irrigate surgical drain with total amount of 12 mg in 10 ml volume once daily for 7 days or until drain removal if less than 7 days of therapy.
|
Normal Saline Irrigation
The drain will be irrigated twice/day with normal saline
Placebo: The placebo group will receive drain irrigation twice/day
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antibiotic Irrigations for Intra-Abdominal Drains
Baseline characteristics by cohort
| Measure |
Antibiotic Irrigation
n=1 Participants
The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum
Gentamicin Sulfate Inj 20mg/2ml vial for injection: Irrigate surgical drain with total amount of 5 mg in 10 ml volume twice/day for 7 days or until drain removal if less than 7 days of therapy.
Clindamycin phosphate 6 mg/1ml for injection: Irrigate surgical drain with total amount of 12 mg in 10 ml volume once daily for 7 days or until drain removal if less than 7 days of therapy.
|
Normal Saline Irrigation
n=1 Participants
The drain will be irrigated twice/day with normal saline
Placebo: The placebo group will receive drain irrigation twice/day
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Age, Continuous
|
40 years
n=136 Participants
|
47 years
n=136 Participants
|
43.5 years
n=272 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=136 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=136 Participants
|
1 participants
n=136 Participants
|
2 participants
n=272 Participants
|
PRIMARY outcome
Timeframe: From initiation of systemic treatment until 1 month follow upPopulation: Due to early termination with one participant per group, outcomes are reported descriptively. No statistical analysis was performed. All available antibiotic exposure data from clinical records were included.
Total duration of systemic antibiotics will be recorded from the start of the treatment until discontinuation by primary care team. This will be measured as days from diagnosis to when the antibiotic treatment gets interrupted. Duration of systemic antibiotics will be our primary outcome measurement. Duration of systemic antibiotics will be monitored as an indication of the effectiveness of the proposed intervention.
Outcome measures
| Measure |
Antibiotic Irrigation
n=1 Participants
The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum
Gentamicin Sulfate Inj 20mg/2ml vial for injection: Irrigate surgical drain with total amount of 5 mg in 10 ml volume twice/day for 7 days or until drain removal if less than 7 days of therapy.
Clindamycin phosphate 6 mg/1ml for injection: Irrigate surgical drain with total amount of 12 mg in 10 ml volume once daily for 7 days or until drain removal if less than 7 days of therapy.
|
Normal Saline Irrigation
n=1 Participants
The drain will be irrigated twice/day with normal saline
Placebo: The placebo group will receive drain irrigation twice/day
|
|---|---|---|
|
Duration of Systemic Antibiotics:
|
19 days
|
26 days
|
SECONDARY outcome
Timeframe: From initiation of systemic treatment until 1 month follow upPopulation: Outcomes are reported descriptively due to early termination of the study with one participant per group. White blood count data were abstracted from clinical records where available. This data was not available for normal saline group due to early termination of the study and cannot be reported.
White blood count level from the blood draw will be measured starting from the admission until discharge or discontinuation by primary care team. During follow up, if white blood count will be measured, will record up to 1 month follow up. The white blood count will be measured once daily and as needed depending on clinical changes. We will plan to trend WBC as another indication of decreasing systemic inflammation.
Outcome measures
| Measure |
Antibiotic Irrigation
n=1 Participants
The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum
Gentamicin Sulfate Inj 20mg/2ml vial for injection: Irrigate surgical drain with total amount of 5 mg in 10 ml volume twice/day for 7 days or until drain removal if less than 7 days of therapy.
Clindamycin phosphate 6 mg/1ml for injection: Irrigate surgical drain with total amount of 12 mg in 10 ml volume once daily for 7 days or until drain removal if less than 7 days of therapy.
|
Normal Saline Irrigation
The drain will be irrigated twice/day with normal saline
Placebo: The placebo group will receive drain irrigation twice/day
|
|---|---|---|
|
White Blood Count
|
17.5 10^9 cells per liter
|
—
|
SECONDARY outcome
Timeframe: From initiation of systemic treatment until 1 month follow upPopulation: Outcomes are reported descriptively due to early termination of the study with one participant per group. Temperature data were abstracted from clinical records where available. This data was not available for normal saline group due to early termination of the study and cannot be reported.
Temperature will be measured every 8 hours starting from admission and until patient discharge. And also temperature will be measured during each follow up clinic visit. Change in temperature is monitored as an indication of decrease systemic inflammation.
Outcome measures
| Measure |
Antibiotic Irrigation
n=1 Participants
The drain will be irrigated twice/day with the above antibiotic solution for 7 days maximum
Gentamicin Sulfate Inj 20mg/2ml vial for injection: Irrigate surgical drain with total amount of 5 mg in 10 ml volume twice/day for 7 days or until drain removal if less than 7 days of therapy.
Clindamycin phosphate 6 mg/1ml for injection: Irrigate surgical drain with total amount of 12 mg in 10 ml volume once daily for 7 days or until drain removal if less than 7 days of therapy.
|
Normal Saline Irrigation
The drain will be irrigated twice/day with normal saline
Placebo: The placebo group will receive drain irrigation twice/day
|
|---|---|---|
|
Maximum Temperature From Initiation of Systemic Treatment Until 1 Month Follow up
|
39.7 °C
|
—
|
Adverse Events
Antibiotic Irrigation
Normal Saline Irrigation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place