NCT02390401

Vacuum Assisted Closure for Cesarean Section

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Surgical Wound Infection

Interventions

Type	Name	Description
DEVICE	Vacuum-assisted closure	Prevena (VAC) device at the time of primary closure for a cesarean section, left in place for 5-7 days postoperatively.
DEVICE	Standard sterile dressing	Standard sterile dressing at the time of primary closure for a cesarean section, left in place for 1-2 days postoperatively.

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-07-01
• Completion: 2017-09-01
• First posted: 2015-03-17
• Last updated: 2018-05-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study