Vacuum Assisted Closure for Cesarean Section — VACCS  

Surgical Wound Infection Clinical Trial

Official title: Incisional VAC at Cesarean Section for Prevention of Post Operative Wound Complications in the Obese

Status Terminated

Clinical Trial Summary

To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean section incisions in the obese compared with standard sterile dressing.

Clinical Trial Description

The prevalence of obesity (defined as body mass index (BMI, kg/m2) ≥ 30) has significantly increased, affecting approximately 35% of adult females in the United States, according to CDC 2009-2010 statistics. Obesity has a significant impact on pregnancy, including increased need for cesarean section and post-operative wound complications. Infection rates have been reported to be between 10 and 30%. The advent in 1997 of negative pressure therapy (NPT), also known as vacuum assisted closure (VAC), has vastly changed wound care management. Briefly, VAC has been traditionally applied to a chronic wound to create negative or sub-atmospheric pressure, thus promoting wound healing by decreasing edema and increasing blood flow and formation of granulation tissue. Use of this therapy at the time of primary closure of a surgical incision (first trialed in 2006 and termed "Incisional VAC") has provided a promising approach to reducing post-operative wound infection. Incisional VAC has been explored primarily in the orthopedic and cardiothoracic fields, but very few studies have examined the use on abdominal incisions, and only one to date on cesarean section incisions. ;

Related Conditions & MeSH terms

• Surgical Wound
• Surgical Wound Infection
• Wound Infection

• NCT number: NCT02390401
• Study type: Interventional
• Source: Dartmouth-Hitchcock Medical Center
• Status: Terminated
• Phase: Phase 1
• Start date: May 2015
• Completion date: September 2017