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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Complications; Caesarean Section, Wound
• Intervention / Treatment: Device: Standard Dressing; Device: Silverlon

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Von Voigtlander Womens' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Standard Dressing; Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing	Device: Standard Dressing; 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.
EXPERIMENTAL: Silverlon; Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing	Device: Silverlon; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Cura Surgical
• Investigators: Principal Investigator: Mark Chames, MD, University of Michigan; Principal Investigator: Angela Liang, MD, University of Michigan

Publications and helpful links

General Publications

• Krieger BR, Davis DM, Sanchez JE, Mateka JJ, Nfonsam VN, Frattini JC, Marcet JE. The use of silver nylon in preventing surgical site infections following colon and rectal surgery. Dis Colon Rectum. 2011 Aug;54(8):1014-9. doi: 10.1097/DCR.0b013e31821c495d.
• Epstein NE. Do silver-impregnated dressings limit infections after lumbar laminectomy with instrumented fusion? Surg Neurol. 2007 Nov;68(5):483-5; discussion 485. doi: 10.1016/j.surneu.2007.05.045.
• Huckfeldt R, Redmond C, Mikkelson D, Finley PJ, Lowe C, Robertson J. A clinical trial to investigate the effect of silver nylon dressings on mediastinitis rates in postoperative cardiac sternotomy incisions. Ostomy Wound Manage. 2008 Oct;54(10):36-41.

Helpful Links

• University of Michigan Department of Obstetrics and Gynecology

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: February 1, 2012
• First Submitted That Met QC Criteria: February 7, 2012
• First Posted (ESTIMATE): February 8, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Cesarean Section; Wound care
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: HUM00037674