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

NCT03082664 | Completed Results FDA Device

• 1 other identifier: 1412596588
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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).

Conditions

High Risk Pregnancy; Cesarean Wound Disruption With Postnatal Complication

Outcome Measures

Primary Outcomes (1)

• Wound Complication

  Number of study participants with a wound complication including wound breakdown, infection, separation or dehiscence

  post operative day 1-42

Study Arms (2)

Standard dressing

NO INTERVENTION

Standard dressing will be applied after C-section.

PICO dressing

EXPERIMENTAL

Device: PICO Single Use Negative Pressure Wound Therapy

Device: PICO Single Use Negative Pressure Wound Therapy

Interventions

PICO Single Use Negative Pressure Wound Therapy DEVICE

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

Also known as: Smith & Nephew PICO patch

PICO dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maternal Age 18 or above
• Cesarean delivery
• 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.
• Patient able to read and speak English or Spanish.

You may not qualify if:

• Minors (\<18 years of age)
• Non-cesarean wound (ie tubal ligation wound)
• No high risk maternal condition
• Patient unable to read and speak English or Spanish.
• Prisoners

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center Tucson

Tucson, Arizona, 85724, United States

Location

Related Publications (1)

• 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.

  PMID: 37140175 DERIVED

Results Point of Contact

• Title: Dr. Maritza G. Gonzalez
• Organization: University of Chicago

mggonzalez@bsd.uchicago.edu

7737026118

Study Officials

• Meghan Hill, MBBS

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 17, 2017
• Study Start: June 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 26, 2022
• Results First Posted: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)