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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
166
Prevena (VAC) device at the time of primary closure for a cesarean section, left in place for 5-7 days postoperatively.
Standard sterile dressing at the time of primary closure for a cesarean section, left in place for 1-2 days postoperatively.
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
Post-operative wound infection
Determine number of post-operative wound infections
Time frame: 6 weeks post-operative
Rate of seroma
Calculate incidence of seroma
Time frame: 6 weeks post-operative
Rate of hematoma
Calculate incidence of hematoma
Time frame: 6 weeks post-operative
Deep and superficial infection
Calculate incidence of deep and superficial infection
Time frame: 6 weeks post-operative
Readmission for infection
Calculate incidence of readmission to hospital for infection due to cesarean incision
Time frame: 6 weeks post-operative
Re-operation
Calculate incidence of re-operation to patients enrolled in study
Time frame: 6 weeks post-operative
Antibiotic treatment
Calculate incidence of need for antibiotic treatment for enrolled patients
Time frame: 6 weeks post-operative
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