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

April 20, 2022 updated by: HealthPartners Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1064

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55403
        • Regions Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

adult women requiring cesarean section

Description

Inclusion Criteria:

  • adult women, pregnant

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
low risk, silver impregnated
Device: silver impregnated dressing
comparison of Mepilex versus our standard techniques
Other Names:
  • Mepilex
  • Wound vacuum
low risk, border bandage
high-risk, silver impregnated
Device: silver impregnated dressing
comparison of Mepilex versus our standard techniques
Other Names:
  • Mepilex
  • Wound vacuum
high-risk, wound vacuum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection Rate
Time Frame: 30 days from surgery
rate of post operative infection
30 days from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Investigators

  • Principal Investigator: Larry Goldenberg, Regions Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

October 4, 2020

First Submitted That Met QC Criteria

October 4, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A180389

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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