This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been terminated.
(Insufficient Recruitment)
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 15, 2017
Last verified: February 2017
  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: Silverlon Device: Standard Dressing Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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:


Further study details as provided by Mark Chames, MD, University of Michigan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 37
Study Start Date: February 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Michigan
University of Michigan Von Voigtlander Womens' Hospital
Ann Arbor, Michigan, United States, 48109
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:
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
Results First Received: December 22, 2016
Last Updated: February 15, 2017

Keywords provided by Mark Chames, MD, University of Michigan:
Obesity
Cesarean Section
Wound care

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on July 21, 2017