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

Completed

• Conditions: D011247; D001458
• Interventions: Device: silver impregnated dressing

• Registration Number: NCT04582045
• Lead Sponsor: HealthPartners Institute

Brief Summary

Effect of Prophylactic Negative Pressure versus Silver Impregnated Silicone Bandage on Cesarean Section Surgical Site Infection Rate

Detailed Description

Comparison of effect of Prophylactic Negative Pressure versus Silver Impregnated Silicone Bandage on Cesarean Section Surgical Site Infection Rate as compared to wound vacuum in high risk women and traditional border dressing in low risk women in adult women having uncomplicated cesarean section.

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2020-10-04
• Study First Submitted QC: 2020-10-04
• Study First Posted: 2020-10-09
• Primary Completion: 2021-03-01
• Study Completion: 2021-06-15
• Status Verified: 2021-12
• Results First Submitted: 2022-02-15
• Results First Submitted QC: 2022-04-20
• Last Update Submitted: 2022-04-20
• Results First Posted: 2023-01-19
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1064

Inclusion Criteria

• adult women, pregnant

Exclusion Criteria

• <18 years old
• surgery complicated by non-routine surgeries (Such as appendectomy)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
low risk, silver impregnated	silver impregnated dressing	low risk, silver impregnated
high-risk, silver impregnated	silver impregnated dressing	high-risk, silver impregnated

Primary Outcome Measures

Name	Time	Method
Infection Rate	30 days from surgery	rate of post operative infection

Trial Locations

Locations (1)

Regions Hospital; 🇺🇸 Saint Paul, Minnesota, United States