Trial Outcomes & Findings for Effect of Prophylactic Negative Pressure Versus Silver Impregnated Silicone Bandage on C-Section Infection Rates (NCT NCT04582045)

NCT ID: NCT04582045

Last Updated: 2023-01-19

Results Overview

rate of post operative infection

• Recruitment status: COMPLETED
• Target enrollment: 1064 participants
• Primary outcome timeframe: 30 days from surgery
• Results posted on: 2023-01-19

Participant Flow

Participant milestones

Measure	Low Risk, Silver Impregnated low risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques	Low Risk, Border Bandage low risk, border (traditional) bandage	High-risk, Silver Impregnated high-risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques	High-risk, Wound Vacuum high-risk, negative-pressure wound vacuum
Overall Study STARTED	446	440	95	83
Overall Study COMPLETED	446	440	95	83
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Prophylactic Negative Pressure Versus Silver Impregnated Silicone Bandage on C-Section Infection Rates

Baseline characteristics by cohort

Measure	Low Risk, Silver Impregnated n=446 Participants low risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques	Low Risk, Border (Traditional) Bandage n=440 Participants low risk, border (traditional) bandage standard border wound bandage	High-risk, Silver Impregnated n=95 Participants high-risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques	High-risk, Negative-pressure Wound Vacuum n=83 Participants high-risk, negative-pressure wound vacuum Commercially available negative-pressure wound vacuum	Total n=1064 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	446 Participants n=5 Participants	440 Participants n=7 Participants	95 Participants n=5 Participants	83 Participants n=4 Participants	1064 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Female	446 Participants n=5 Participants	440 Participants n=7 Participants	95 Participants n=5 Participants	83 Participants n=4 Participants	1064 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	67 Participants n=5 Participants	66 Participants n=7 Participants	14 Participants n=5 Participants	12 Participants n=4 Participants	159 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	379 Participants n=5 Participants	374 Participants n=7 Participants	81 Participants n=5 Participants	71 Participants n=4 Participants	905 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	85 Participants n=5 Participants	79 Participants n=7 Participants	17 Participants n=5 Participants	14 Participants n=4 Participants	195 Participants n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	183 Participants n=5 Participants	185 Participants n=7 Participants	40 Participants n=5 Participants	36 Participants n=4 Participants	444 Participants n=21 Participants
Race (NIH/OMB) White	178 Participants n=5 Participants	176 Participants n=7 Participants	38 Participants n=5 Participants	33 Participants n=4 Participants	425 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	446 participants n=5 Participants	440 participants n=7 Participants	95 participants n=5 Participants	83 participants n=4 Participants	1064 participants n=21 Participants
Enrollment Parameters	446 Participants n=5 Participants	440 Participants n=7 Participants	95 Participants n=5 Participants	83 Participants n=4 Participants	1064 Participants n=21 Participants

PRIMARY outcome

Timeframe: 30 days from surgery

rate of post operative infection

Outcome measures

Measure	Low Risk, Silver Impregnated n=446 Participants low risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques	Low Risk, Border Bandage n=440 Participants low risk, (traditional) border bandage	High-risk, Silver Impregnated n=95 Participants high-risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques	High-risk, Wound Vacuum n=83 Participants high-risk, negative-pressure wound vacuum
Infection Rate	17 Participants	18 Participants	5 Participants	5 Participants

Adverse Events

Low Risk, Silver Impregnated

Serious events: 24 serious events

Other events: 6 other events

Deaths: 0 deaths

Low Risk, Border Bandage

Serious events: 13 serious events

Other events: 3 other events

Deaths: 0 deaths

High-risk, Silver Impregnated

Serious events: 5 serious events

Other events: 2 other events

Deaths: 0 deaths

High-risk, Wound Vacuum

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Low Risk, Silver Impregnated n=446 participants at risk low risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques	Low Risk, Border Bandage n=440 participants at risk low risk, (traditional) border bandage	High-risk, Silver Impregnated n=95 participants at risk high-risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques	High-risk, Wound Vacuum n=83 participants at risk high-risk, negative-pressure wound vacuum
Reproductive system and breast disorders POST-PARTUM HOSPITALIZATION (6-months)	5.4% 24/446 • Number of events 29 • 180-days post delivery (6-months)	3.0% 13/440 • Number of events 14 • 180-days post delivery (6-months)	5.3% 5/95 • Number of events 7 • 180-days post delivery (6-months)	1.2% 1/83 • Number of events 1 • 180-days post delivery (6-months)

Other adverse events

Measure	Low Risk, Silver Impregnated n=446 participants at risk low risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques	Low Risk, Border Bandage n=440 participants at risk low risk, (traditional) border bandage	High-risk, Silver Impregnated n=95 participants at risk high-risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques	High-risk, Wound Vacuum n=83 participants at risk high-risk, negative-pressure wound vacuum
Skin and subcutaneous tissue disorders Superficial Wound Infections	1.3% 6/446 • Number of events 6 • 180-days post delivery (6-months)	0.68% 3/440 • Number of events 3 • 180-days post delivery (6-months)	2.1% 2/95 • Number of events 2 • 180-days post delivery (6-months)	3.6% 3/83 • Number of events 3 • 180-days post delivery (6-months)

Additional Information

Linda M. Loes

HealthPartners Institute

Phone: 952-967-7862

Email: linda.m.loes@healthpartners.com

Results disclosure agreements

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