Clinical trial NCT03082664: Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Patients
Official title: Topical Negative Pressure Wound Therapy to Prevent Wound Complications Following Cesarean Section in High Risk Obstetric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Risk Pregnancy
Cesarean Wound Disruption With Postnatal Complication
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial. Patients with a condition that increases their risk of a wound complication will be approached for inclusion in the trial. Each participant agreeing to study inclusion will be randomized to either suture alone or to closure of their skin incision with suture and then with prophylactic placement of a wound vac (PICO).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Wound Complication
timeFrame: post operative day 1-42
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center Tucson
state: Arizona
Study officials:
affiliation: University of Arizona
name: Meghan Hill, MBBS
role: PRINCIPAL_INVESTIGATOR
References: