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

NCT03082664 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2022-09-26

Study results available
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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

Interventions

DEVICE

PICO Single Use Negative Pressure Wound Therapy

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

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Meghan Hill, MBBS · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2019-03-31
Completion
2019-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03082664 on ClinicalTrials.gov