Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section
Primary Purpose
Obesity, Complications; Caesarean Section, Wound
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Silverlon
Standard Dressing
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Cesarean Section, Wound care
Eligibility 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
Sites / Locations
- University of Michigan Von Voigtlander Womens' Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Standard Dressing
Silverlon
Arm Description
Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing
Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Full Information
NCT ID
NCT01528696
First Posted
February 1, 2012
Last Updated
February 15, 2017
Sponsor
University of Michigan
Collaborators
Cura Surgical
1. Study Identification
Unique Protocol Identification Number
NCT01528696
Brief Title
Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section
Official Title
Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Insufficient Recruitment
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Cura Surgical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Complications; Caesarean Section, Wound
Keywords
Obesity, Cesarean Section, Wound care
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Dressing
Arm Type
Placebo Comparator
Arm Description
Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing
Arm Title
Silverlon
Arm Type
Experimental
Arm Description
Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing
Intervention Type
Device
Intervention Name(s)
Silverlon
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard Dressing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Patients Who Experience One or More Wound Complications
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Febrile Morbidity
Description
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.
Time Frame
2 days, 6 weeks
Title
Patient Report of Pain Severity and Control
Description
Self Reported pain, on a scale from 1 to 10, where 1 is little pain and 10 is extreme pain
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Chames, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angela Liang, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Von Voigtlander Womens' Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21730792
Citation
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.
Results Reference
background
PubMed Identifier
17961738
Citation
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.
Results Reference
background
PubMed Identifier
18927482
Citation
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.
Results Reference
background
Links:
URL
http://obgyn.med.umich.edu/
Description
University of Michigan Department of Obstetrics and Gynecology
URL
http://ww.curasurgical.com
Description
Cura Surgical
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Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section
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