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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2016

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.

Interventions

  • Device: Acticoat PostOp
  • Device: OpSite PostOp

Arms, Groups and Cohorts

  • Active Comparator: Silver containing dressing
    • Subjects will have a silver containing dressing (Acticoat PostOp) applied at the time of elective cesarean section.
  • Placebo Comparator: Standard dressing
    • Subjects will have a standard dressing (OpSite PostOp) applied at the time of elective cesarean section.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Saskatchewan Health Authority – Regina Area
  • Provider of Information About this Clinical Study
    • Sponsor

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