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

University of Michigan

Status and phase: Terminated; Phase 4

Conditions: Obesity; Complications; Caesarean Section, Wound

Treatments: Device: Silverlon; Device: Standard Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT01528696

HUM00037674

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 37 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 2 patient groups, including a placebo group

Standard Dressing

Placebo Comparator group

Description:

Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing

Treatment:

Device: Standard Dressing

Silverlon

Experimental group

Description:

Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing

Treatment:

Device: Silverlon