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

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

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Complications; Caesarean Section, Wound	Device: Silverlon; Device: Standard Dressing	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Silver Impregnated Dressings to Reduce Wound Complications in Obese Patients at Cesarean Section
• Study Start Date: February 2012
• Actual Primary Completion Date: January 2013
• Actual Study Completion Date: January 2013

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.
2. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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:

University of Michigan Department of Obstetrics and Gynecology 

Publications:

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.

Epstein NE. Do silver-impregnated dressings limit infections after lumbar laminectomy with instrumented fusion? Surg Neurol. 2007 Nov;68(5):483-5; discussion 485.

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.

• Responsible Party: Mark Chames, MD, Assistant Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT01528696
• Other Study ID Numbers: HUM00037674
• First Posted: February 8, 2012
• Results First Posted: April 4, 2017
• Last Update Posted: April 4, 2017
• Last Verified: February 2017

Keywords provided by Mark Chames, MD, University of Michigan:

Obesity; Cesarean Section; Wound care

Additional relevant MeSH terms:

Wounds and Injuries