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

High Risk Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082664
• Other study ID #: 1412596588
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2019

Study information

• Verified date: September 2022
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Wound Disruption With Postnatal Complication
• High Risk Pregnancy
• Wounds and Injuries

Intervention

Device:
• PICO Single Use Negative Pressure Wound Therapy
The PICO device will be placed over the closed cesarean section incision.

Locations

Country	Name	City	State
United States	Banner University Medical Center Tucson	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Complication	Number of study participants with a wound complication including wound breakdown, infection, separation or dehiscence	post operative day 1-42