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

NCT01528696 | Terminated Phase 4 Results

• 1 other identifier: HUM00037674
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Complications; Caesarean Section, Wound

Keywords

Obesity; Cesarean Section; Wound care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Febrile Morbidity

  2 days, 6 weeks

• Patient Report of Pain Severity and Control

  6 weeks

Study Arms (2)

Standard Dressing

PLACEBO COMPARATOR

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

Device: Standard Dressing

Silverlon

EXPERIMENTAL

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

Device: Silverlon

Interventions

Silverlon DEVICE

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.

Silverlon

Standard Dressing DEVICE

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.

Standard Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Cura Surgical: collaborator

Study Sites (1)

University of Michigan Von Voigtlander Womens' Hospital

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (3)

• 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.

  PMID: 21730792 BACKGROUND

• 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.

  PMID: 17961738 BACKGROUND

• 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.

  PMID: 18927482 BACKGROUND

Related Links

• University of Michigan Department of Obstetrics and Gynecology
• Cura Surgical

MeSH Terms

Conditions

Obesity; Wounds and Injuries

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mark Chames
• Organization: University of Michigan

mchames@med.umich.edu

734 764-1406

Study Officials

• Mark Chames, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Angela Liang, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 8, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-02

Locations

US (1)