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External Negative Pressure Dressing System vs. Traditional Wound Dressing for Cesarean Section Incision in Obese Women.

NCT04434820 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2021-02-18

No results posted yet for this study

Summary

Obesity is associated with increased cesarean section delivery rates and surgical site infections with associated increased post-operative morbidity, post-operative pain and length of hospital stay.

Negative pressure wound therapy (NPWT) technology could be used as a prophylactic measure to reduce surgical site infections in obese women undergoing cesarean section by immediate postoperative application in clean-contaminated, closed surgical incisions.

Conditions

  • Wound Dehiscence

Interventions

DEVICE

External negative pressure dressing system (Yuwell 7E-A portable suction unit)

A portable suction unit that will deliver 125 mm Hg of continuous pressure to the dressing and will remove exudates into a disposable canister for 4 days.

Sponsors & Collaborators

  • Ain Shams Maternity Hospital

    lead OTHER

Principal Investigators

  • Dalia M Mokhtar, MBBCh · resident of obstetrics and gynecology

  • Marwan O Elkady, MD · Lecturer of obstetrics and gynecology

  • Mohammed S El Sokkary, MD · Professor of obstetrics and gynecology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2021-02-03
Completion
2021-02-04
FDA Device
Yes

Countries

  • Egypt

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 NCT04434820 on ClinicalTrials.gov