Trial Outcomes & Findings for The Role of Antimicrobial Foam Dressing in Prevention of Cesarean Section Wound Complications (NCT NCT03136159)

NCT ID: NCT03136159

Last Updated: 2020-12-21

Results Overview

Rate of wound disruption and /or infection occurring by 6 weeks was compared to a historical control rate of 10%, and to a contemporary group who received a standard dressing

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 380 participants
• Primary outcome timeframe: 6 weeks postoperative
• Results posted on: 2020-12-21

Participant Flow

Recruitment of all women admitted to labor and delivery or antepartum service to receive the silver-impregnated dressing should they deliver by primary csection

Participant milestones

Measure	Silver Dressing Group Those with primary csection and transverse incision subcuticular closure who consented to receive the silver dressing	Standard Dressing Group Those who had a primary csection with transverse incision subcuticular closure but who had declined to receive the silver dressing
Overall Study STARTED	190	190
Overall Study COMPLETED	185	190
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Measure	Silver Dressing Group Those with primary csection and transverse incision subcuticular closure who consented to receive the silver dressing	Standard Dressing Group Those who had a primary csection with transverse incision subcuticular closure but who had declined to receive the silver dressing
Overall Study chorioamnionitis	2	0
Overall Study vertical skin incision	1	0
Overall Study additional dressing	1	0
Overall Study never got dressing placed	1	0

Baseline Characteristics

The Role of Antimicrobial Foam Dressing in Prevention of Cesarean Section Wound Complications

Baseline characteristics by cohort

Measure	Silver-impregnated Antimicrobial Dressing n=185 Participants All participants undergoing primary cesarean section will receive a silver impregnated antimicrobial wound dressing (Mepilex Border AG), postoperative. Silver-impregnated antimicrobial dressing: All participants will receive an adherent soft silicone silver impregnated anti-microbial occlusive foam dressing after cesarean section. The dressing will stay on for up to seven days.	Standard Dressing n=190 Participants Those who had a primary csection with transverse incision and subcuticular closure but who had declined to receive the silver dressing. Standard dressing: Telfa antimicrobial non-adherent island dressing covered with 10 sterile 4X4 gauge sponges secured wityh Tegaderm film tape. Dressing removed postop day 1 per routine.	Total n=375 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	185 Participants n=5 Participants	190 Participants n=7 Participants	375 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.47 years STANDARD_DEVIATION 6.34 • n=5 Participants	29.21 years STANDARD_DEVIATION 6.23 • n=7 Participants	29.83 years STANDARD_DEVIATION 6.31 • n=5 Participants
Sex: Female, Male Female	185 Participants n=5 Participants	190 Participants n=7 Participants	375 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	41 Participants n=5 Participants	56 Participants n=7 Participants	97 Participants n=5 Participants
Race (NIH/OMB) White	125 Participants n=5 Participants	112 Participants n=7 Participants	237 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment United States	185 participants n=5 Participants	190 participants n=7 Participants	375 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks postoperative

Population: 185 of original 190 who received silver dressing included in analysis. Five excluded (2 with chorioamnionitis, 1 vertical incision, 1 additional dressing applied, 1 never received silver dressing)

Rate of wound disruption and /or infection occurring by 6 weeks was compared to a historical control rate of 10%, and to a contemporary group who received a standard dressing

Outcome measures

Measure	Silver Dressing Group n=185 Participants Those with primary csection and transverse incision subcuticular closure who consented to receive the silver dressing	Standard Dressing Group n=190 Participants Those who had a primary csection with transverse incision subcuticular closure but who had declined to receive the silver dressing
Number of Participants With Wound Disruption and/or Infection	5 Participants	9 Participants

Adverse Events

Silver Dressing Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Standard Dressing Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Silver Dressing Group n=185 participants at risk Those with primary csection and transverse incision subcuticular closure who consented to receive the silver dressing	Standard Dressing Group n=190 participants at risk Those who had a primary csection with transverse incision subcuticular closure but who had declined to receive the silver dressing
Skin and subcutaneous tissue disorders pruritis	1.6% 3/185 • Number of events 3 • until 6 weeks postdelivery	0.00% 0/190 • until 6 weeks postdelivery

Additional Information

Dr Jean Goodman

Loyola University Medical Center

Phone: 7082165459

Email: Jrgoodman@lumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place