Negative Pressure Wound Therapy in Cesarean Section

This will be a prospective, randomized, controlled trial of pregnant women who present for
prenatal care at Parkland Health and Hospital System. The participants will be limited to
women undergoing a cesarean section who are high risk for wound complications: all patients
with a BMI > 40 undergoing cesarean section.

The primary outcome will be wound complication defined as wound disruption or wound
infection. A wound disruption will be defined as the partial or complete opening of the deep
subcutaneous space, not to include superficial skin separation. Underlying causes will
include seroma, hematoma, abscess, and facial dehiscence. Wound infection will be defined as
a physician diagnosis of wound infection with erythema and warmth extending beyond the
immediate area adjacent to the incision and requiring treatment with antibiotics.

All patients with a BMI > 40 undergoing scheduled cesarean section and patients with a BMI
>40 who are admitted in labor will be approached to participate in the study. If patients
meeting this criteria undergo cesarean section, they will be randomized to negative pressure
wound therapy or a standard dressing. All labor treatment, pre-operative antibiotics,
surgical technique, and post-operative care will not differ from current standard of care.
All patients randomized will be included in the study.

All study participants will have the thickness of their subcutaneous tissue measured with a
sterile ruler. Patients randomized to NPWT will have a negative pressure wound therapy system
placed over her incision per the manufacturer's protocol. All patients randomized to standard
dressing will have the customary dressing of gauze and surgical tape placed over her
incision.

The investigators will be utilizing a single use negative pressure wound therapy system for
the study. Single use negative pressure wound therapy systems are composed of a pressure pump
and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the
dressing directly covers surgical incision. The system is battery-powered and designed to be
used for a minimum of two days and a maximum of seven days of continuous use.

All randomized patients will undergo an examination of their incision by a research physician
or nurse prior to discharge. The NPWT will be removed prior to discharge or on post-operative
day seven, whichever comes first. All postpartum patients who undergo a cesarean delivery are
inpatients until at least post-operative day three and will continue use of NPWT until day of
discharge. In patients randomized to a standard dressing, the dressing will be removed prior
to discharge per current standard of care.

All randomized patients will also undergo a 2 week post-operative incisional examination by a
research physician or nurse at the obstetrical complications clinic. Patients will be
followed until 30 days postpartum for any wound complications to include wound infection
(superficial and deep), readmission to the hospital, re-operation for wound complications,
hematoma, seroma, dehiscence, superficial infection requiring antibiotics, or additional
clinical evaluations for wound care in the emergency room or clinic setting. A research
physician or nurse will contact each after at least 30 days post-operative to confirm the
patients' status and ensure no evaluations, admissions, or interventions were done at outside
facilities.

Subjects will exit the study if they are unable to complete the post-operative visit or
withdrawal consent for participation.

Inclusion Criteria:

- Pregnant women with BMI > 40 undergoing a cesarean delivery at Parkland Health and
Hospital System.

Exclusion Criteria:

- Any patient not meeting inclusion criteria will be deemed ineligible.

- All HIV positive patients will be excluded due to the increased risk of infectious
complications in these patients.

- Although patients on anticoagulants can use NPWT, they will be excluded as there may
be an increased risk of bleeding in these patients.

- according to the wound therapy manufacturer's instructions patients with:

- fragile skin

- allergy to silver or acrylic adhesives

- a malignancy in the wound bed or margins of the wound bed

- non-enteric and unexplored fistulas

- necrotic tissue with eschar present

- exposed arteries, veins, nerves or organs, anastomotic sites, or surgical suction
are not candidates for usage of the device.