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Vacuum Assisted Closure for Cesarean Section

NCT02390401 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2018-05-22

No results posted yet for this study

Summary

To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean section incisions in the obese compared with standard sterile dressing.

Conditions

  • Surgical Wound Infection

Interventions

DEVICE

Vacuum-assisted closure

Prevena (VAC) device at the time of primary closure for a cesarean section, left in place for 5-7 days postoperatively.

DEVICE

Standard sterile dressing

Standard sterile dressing at the time of primary closure for a cesarean section, left in place for 1-2 days postoperatively.

Sponsors & Collaborators

  • Southern New Hampshire Medical Center

    collaborator OTHER

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Zachary Spalding, MD · Dartmouth-Hitchcock Medical Center

  • Kristina Wihbey, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-07-31
Completion
2017-09-30
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 NCT02390401 on ClinicalTrials.gov