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

NCT ID: NCT03082664

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2019-12-31

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.

Conditions

High Risk Pregnancy; Cesarean Wound Disruption With Postnatal Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard dressing

Standard dressing will be applied after C-section.

Group Type: NO_INTERVENTION

No interventions assigned to this group

PICO dressing

Device: PICO Single Use Negative Pressure Wound Therapy

Group Type: EXPERIMENTAL

PICO Single Use Negative Pressure Wound Therapy

Intervention Type: DEVICE

The PICO device will be placed over the closed cesarean section incision.

Interventions

PICO Single Use Negative Pressure Wound Therapy

The PICO device will be placed over the closed cesarean section incision.

Intervention Type: DEVICE

Other Intervention Names

Smith & Nephew PICO patch

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Meghan Hill

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meghan Hill, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

Banner University Medical Center Tucson

Tucson, Arizona, United States

Countries

United States

References

Gonzalez MG, Barske ME, Kjellsson KB, Saboda K, Reed HA, Hill MG. Topical negative pressure wound therapy to prevent wound complications following caesarean delivery in high-risk obstetric patients: A randomised controlled trial. Aust N Z J Obstet Gynaecol. 2023 Aug;63(4):516-520. doi: 10.1111/ajo.13675. Epub 2023 May 4.

Reference Type: DERIVED

PMID: 37140175 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

1412596588

Identifier Type: -

Identifier Source: org_study_id