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

Not Applicable

Completed

• Conditions: Surgical Wound Infection
• Interventions: Device: Acticoat PostOp; Device: OpSite PostOp

• Registration Number: NCT02288884
• Lead Sponsor: Saskatchewan Health Authority - Regina Area

Brief Summary

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).

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-11
• Status Verified: 2016-04
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silver containing dressing	Acticoat PostOp	Subjects will have a silver containing dressing (Acticoat PostOp) applied at the time of elective cesarean section.
Standard dressing	OpSite PostOp	Subjects will have a standard dressing (OpSite PostOp) applied at the time of elective cesarean section.

Primary Outcome Measures

Name	Time	Method
Wound complication	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.

Trial Locations

Locations (1)

Regina General Hospital; 🇨🇦 Regina, Saskatchewan, Canada