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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgical Wound Infection

Intervention / Treatment
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* Device: Acticoat PostOp
* Device: OpSite PostOp


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound complication | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complications, Cesarean Section, Wound, Infection (Following Delivery)