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

Phase 4

Terminated

• Conditions: Complications; Caesarean Section, Wound; Obesity
• Interventions: Device: Standard Dressing; Device: Silverlon

• Registration Number: NCT01528696
• Lead Sponsor: University of Michigan

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-08
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2016-12-22
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-15
• Last Update Submitted: 2017-02-15
• Results First Posted: 2017-04-04
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 37

Inclusion Criteria

• Undergoing cesarean section (with or without concurrent tubal ligation)
• Body mass index (based on most recent weight) >=30

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Dressing	Standard Dressing	Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing
Silverlon	Silverlon	Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Experience One or More Wound Complications	6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Febrile Morbidity	2 days, 6 weeks	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.
Patient Report of Pain Severity and Control	6 weeks	Self Reported pain, on a scale from 1 to 10, where 1 is little pain and 10 is extreme pain

Trial Locations

Locations (1)

University of Michigan Von Voigtlander Womens' Hospital; 🇺🇸 Ann Arbor, Michigan, United States