Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section

Study Overview
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Brief Summary
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Obese patients undergoing cesarean section are at high risk for wound complications, which occur in approximately 20% of patients. This is a randomized controlled trial designed to determine whether the risk for wound-related complications can be reduced by covering the incision with a silver-impregnated dressing in the postoperative period.

Detailed Description
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This study's purpose was to evaluate the effect of a FDA approved silver-impregnated dressing on cesarean wound complications in obese women. It was initiated and 37 women were randomized, but because of logistical barriers, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. While a small number of photographs were taken as intended, they were lost due to a technological failure prior to any analysis. Therefore no outcome data could be analyzed. Nonetheless, as patients of the University of Michigan Health System, all research subjects received health care treatment appropriate to their medical condition and circumstances.

Official Title
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Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section

Conditions
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Obesity, Complications; Caesarean Section, Wound

Intervention / Treatment
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* Device: Silverlon
* Device: Standard Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing cesarean section (with or without concurrent tubal ligation) Body mass index (based on most recent weight) >=30 Exclusion Criteria: Known allergy to silver Less than 18 years of age Preoperative evidence of current abdominal wall infection Contraindication to closure of the skin at time of surgery Plan to perform procedures in addition to cesarean section (with or without tubal ligation) Patients with previously placed abdominal wall mesh at site of planned surgery Inability to participate in medical decision making Inability to follow up with the Michigan Visiting Nurses or are unable to return to the University of Michigan Medical Center for staple removal

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Standard Dressing<br>Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing | Device: Standard Dressing<br>* Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse.<br>|
| Experimental: Silverlon<br>Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing | Device: Silverlon<br>* Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse. All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Experience One or More Wound Complications | A composite of cellulitis, wound dehiscence, seroma, hematoma, abscess, and fascial dehiscence from wound evaluation at any point within six weeks, as pulled from the medical record or based on patient report. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Febrile Morbidity | Febrile morbidity would be measured by number of participants who experienced fever as a sign of infection at 2 days, and overall within 6 weeks of delivery. | 2 days, 6 weeks | 
| Patient Report of Pain Severity and Control | Self Reported pain, on a scale from 1 to 10, where 1 is little pain and 10 is extreme pain | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Cesarean Section, Wound care