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

This study is currently recruiting participants.
Verified February 2012 by University of Michigan
Sponsor:
Collaborator:
Cura Surgical
Information provided by (Responsible Party):
Mark Chames, MD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01528696
First received: February 1, 2012
Last updated: February 7, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
Complications; Caesarean Section, Wound
 Device: Dressing Type ( Silverlon)
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Wound complications [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    A composite of cellulitis, wound dehiscence, seroma, hematoma, abscess, and fascial dehiscence


Secondary Outcome Measures:
  • Febrile morbidity [ Time Frame: 2 days, 5 days ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: 2 days, 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Dressing Type ( Silverlon)

    Patients will be randomized to either receive a standard dressing or a silver dressings. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. 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.

    Other Name: Silverlon
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528696

Locations
United States, Michigan
University of Michigan Von Voigtlander Womens' Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Mark Chames, MD     734-764-1406     mchames@med.umich.edu    
Principal Investigator: Mark Chames, MD            
Sub-Investigator: Angela Liang, MD            
Sponsors and Collaborators
University of Michigan
Cura Surgical
Investigators
Principal Investigator: Mark Chames, MD University of Michigan
Principal Investigator: Angela Liang, MD University of Michigan
  More Information

Additional Information:
University of Michigan Department of Obstetrics and Gynecology  This link exits the ClinicalTrials.gov site
Cura Surgical  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Mark Chames, MD, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01528696     History of Changes
Other Study ID Numbers: HUM00037674
Study First Received: February 1, 2012
Last Updated: February 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Obesity
Cesarean Section
Wound care

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013