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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01528696
• Other study ID #: HUM00037674
• Status: Recruiting
• Phase: Phase 4
• First received: February 1, 2012
• Last updated: February 7, 2012
• Start date: February 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2012
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Complications; Caesarean Section, Wound
• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Von Voigtlander Womens' Hospital	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Cura Surgical

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound complications	A composite of cellulitis, wound dehiscence, seroma, hematoma, abscess, and fascial dehiscence	6 weeks	No
Secondary	Febrile morbidity		2 days, 5 days	No
Secondary	Pain		2 days, 6 weeks	No

External Links

•   University of Michigan Department of Obstetrics and Gynecology