Clinical trial NCT01528696: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Obesity
Complications; Caesarean Section, Wound
Keywords: Obesity
Cesarean Section
Wound care
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Cura Surgical
First posted: 2012-02-08
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Patients Who Experience One or More Wound Complications
timeFrame: 6 weeks
Secondary outcomes:
measure: Febrile Morbidity
timeFrame: 2 days, 6 weeks
measure: Patient Report of Pain Severity and Control
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Von Voigtlander Womens' Hospital
state: Michigan
Study officials:
affiliation: University of Michigan
name: Mark Chames, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Angela Liang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.