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Incisional VAC at Cesarean Section for Prevention of Post Operative Wound Complications in the Obese
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.
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Women's Care of Nashua
Nashua, New Hampshire, United States
Dartmouth-Hitchcock Nashua
Nashua, New Hampshire, United States
Southern New Hampshire Medical Center
Nashua, New Hampshire, United States
Start Date
May 1, 2015
Primary Completion Date
July 1, 2017
Completion Date
September 1, 2017
Last Updated
May 22, 2018
166
ACTUAL participants
Vacuum-assisted closure
DEVICE
Standard sterile dressing
DEVICE
Lead Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
NCT07379684
NCT06319235
Data Source & Attribution
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