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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silver containing dressing | Active Comparator | Subjects will have a silver containing dressing (Acticoat PostOp) applied at the time of elective cesarean section. |
|
| Standard dressing | Placebo Comparator | Subjects will have a standard dressing (OpSite PostOp) applied at the time of elective cesarean section. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acticoat PostOp | Device |
| ||
| OpSite PostOp |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regina General Hospital | Regina | Saskatchewan | S4P 0W5 | Canada |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D014947 | Wounds and Injuries |
| D007239 | Infections |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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