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

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ClinicalTrials.gov Identifier: NCT01528696
Recruitment Status : Terminated (Insufficient Recruitment)
First Posted : February 8, 2012
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
Cura Surgical
Information provided by (Responsible Party):
Mark Chames, MD, University of Michigan

Tracking Information
First Submitted Date  ICMJE February 1, 2012
First Posted Date  ICMJE February 8, 2012
Results First Submitted Date  ICMJE December 22, 2016
Results First Posted Date  ICMJE April 4, 2017
Last Update Posted Date April 4, 2017
Study Start Date  ICMJE February 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
Number of Patients Who Experience One or More Wound Complications [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
Wound complications [ Time Frame: 6 weeks ]
A composite of cellulitis, wound dehiscence, seroma, hematoma, abscess, and fascial dehiscence
Change History Complete list of historical versions of study NCT01528696 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
  • Febrile Morbidity [ Time Frame: 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 [ Time Frame: 6 weeks ]
    Self Reported pain, on a scale from 1 to 10, where 1 is little pain and 10 is extreme pain
Original Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2012)
  • Febrile Morbidity [ Time Frame: 2 days, 5 days ]
  • Pain [ Time Frame: 2 days, 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section
Official Title  ICMJE Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Complications; Caesarean Section, Wound
Intervention  ICMJE
  • 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.

  • 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.
Study Arms  ICMJE
  • Placebo Comparator: Standard Dressing
    Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing
    Intervention: Device: Standard Dressing
  • Experimental: Silverlon
    Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing
    Intervention: Device: Silverlon
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 15, 2017)
37
Original Estimated Enrollment  ICMJE
 (submitted: February 7, 2012)
100
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01528696
Other Study ID Numbers  ICMJE HUM00037674
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark Chames, MD, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Cura Surgical
Investigators  ICMJE
Principal Investigator: Mark Chames, MD University of Michigan
Principal Investigator: Angela Liang, MD University of Michigan
PRS Account University of Michigan
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP