Vacuum Assisted Closure for Cesarean Section (VACCS)

Dartmouth Health

Status and phase: Terminated; Phase 1

Conditions: Surgical Wound Infection

Treatments: Device: Vacuum-assisted closure; Device: Standard sterile dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT02390401

D15054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients that have undergone cesarean section for delivery; have a BMI greater or equal to 35. All cases of cesarean section including primary and repeat, scheduled and urgent.

Exclusion criteria

• Patients who deliver vaginally; age less than 18 years old; silver allergy; non-English speaking

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

Vacuum-assisted closure (VAC)

Experimental group

Description:

Prevena (VAC) device

Treatment:

Device: Vacuum-assisted closure

Standard sterile dressing

Active Comparator group

Description:

Standard sterile dressing

Treatment:

Device: Standard sterile dressing