The Use of a Silver Containing Dressing (Acticoat) on Wound Complication Rates Post Elective Cesarean Section

October 12, 2016 updated by: Saskatchewan Health Authority - Regina Area
The purpose of this study is to determine the effect of a silver containing dressing (Acticoat Post-Op) compared to a standard dressing (OpSite PostOp) on post elective cesarean section wound complications in obese women (BMI >35).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women scheduled for an elective cesarean section at term will be recruited to participate in this study. The investigators plan to recruit 100 women. Baseline demographic information will be obtained at the pre-op visit. Eligible subjects will be randomized to received a silver containing dressing (Acticoat PostOp) or the standard dressing (OpSite PostOp). A randomization table will be computer generated in blocks of 20. A sealed opaque envelope containing the assigned dressing will accompany the patient to the operating room. Standard antibiotic prophylaxis will be provided prior to skin incision. A subcuticular suture will be used for skin closure. At the time of skin closure, the envelope will be opened and the assigned dressing will be applied. The dressing will only be changed if it is saturated. The dressing will be removed at the time of discharge from hospital. A questionnaire regarding wound complications will be completed at the time of discharge from hospital, at 2 weeks post-op and 6 weeks post-op.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

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

  • Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 0W5
        • Regina General 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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women scheduled for elective cesarean section
  • BMI >35 at the pre-op visit
  • consent to participate

Exclusion Criteria:

  • allergy to silver
  • immunocompromised (HIV/AIDS, on immunosuppressive medications)

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Silver containing dressing
Subjects will have a silver containing dressing (Acticoat PostOp) applied at the time of elective cesarean section.
Device: Acticoat PostOp
Placebo Comparator: Standard dressing
Subjects will have a standard dressing (OpSite PostOp) applied at the time of elective cesarean section.
Device: OpSite PostOp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound complication
Time Frame: 6 weeks post-op
Composite of: wound infection treated with antibiotics, incision and drainage, wound requiring packing, or patient requiring medical attention for concerns about wound healing.
6 weeks post-op

Collaborators and Investigators

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

Sponsor

Saskatchewan Health Authority - Regina Area

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

May 1, 2011

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 10, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RQhealth

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.

Clinical Trials on Surgical Wound Infection

Clinical Trials on Acticoat PostOp

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe