Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Patients

Once consent has been obtained from patients, an envelope containing the study allocation
will be retrieved from the Pyxis.

- Non-wound vac patients will undergo wound closure with subcutaneous fat closure with
Vicryl in all cases that this is practicable (in extremely thin patients, this may not
be possible), followed by subcuticular skin closure also using Vicryl. A compression
dressing will then be applied. This dressing is usually removed by the clinician the
following day.

- Wound vac (PICO) patients will undergo wound closure with subcutaneous fat closure with
Vicryl in all cases that this is practicable (in extremely thin patients, this may not
be possible), followed by subcuticular skin closure also using Vicryl. The wound vac
system will then be applied over the closed incision. This vac dressing will then be
removed on the day of hospital discharge and replaced with a second bandage and the
wound vacuum will be re-activated. The patient will remove the bandage and discard on
POD#7. This is per the manufacturer's guidelines for length of use.

- If the patient fails the wound vac therapy- ie the wound separates and requires
traditional wound care (packing, wet to dry dressing, etc), then the PICO system is no
longer used as part of their care.

It would be unrealistic to try to standardize the entire operative approach (closure of the
uterus, closure of the fascia) as the different providers working at the hospital may choose
not to participate if the approach specified deviated too much from their usual technique.
Different providers may typically use different kinds or sutures (made of different material,
and of different sizes) or staples to close the subcutaneous fat and the skin. However, for
this study all patients will have the subcutaneous fat and skin closed in the same manner
(with Vicryl suture). To participate in the trial patients will have to agree to these
closure materials. For this study a standard closure with suture was chosen as there is
evidence suggesting a lower rate of wound complications with suture as compared to staples.

The wound will be re-assessed at their 2 week and 6 week post-op follow up visits. The
patients will be assessed by a physician at their post-operative clinic visits. The
physician/investigator will ask the patient if they have had any postoperative complications
since their surgery and will be asked to detail any complications if they answer yes to this
question. The investigators will also obtain permission to call the participants for a
patient satisfaction questionnaire at 1 week post-op, and possibly 2 and 6 weeks if they have
not presented for their post op/partum appointments or the questionnaire could not be
obtained at their visit.

Inclusion Criteria:

1. Maternal Age 18 or above

2. Cesarean delivery

3. Maternal condition which increases the risk of wound complication. These conditions
include: Obesity (BMI >30), diabetes, HIV/AIDS, chorioamnionitis, rheumatologic
disease, history of wound complication, anticoagulant therapy.

4. Patient able to read and speak English or Spanish.

Exclusion Criteria:

1. Minors (<18 years of age)

2. Non-cesarean wound (ie tubal ligation wound)

3. No high risk maternal condition

4. Patient unable to read and speak English or Spanish.

5. Prisoners