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Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Amputations

NCT03250442 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2019-09-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate how well subjects heal after surgery who receive standard dressings or incisional negative pressure wound therapy for non-traumatic amputation sites.

Conditions

  • Surgical Wound
  • Wound Heal
  • Amputation

Interventions

DEVICE

PrevenaTM Device

The PrevenaTM Incision Management System covers and protects the incision from external contamination, while negative pressure removes fluid and infectious material from the surgical incision.

OTHER

Standard Dry Dressing

These are customary dry dressings.

Sponsors & Collaborators

  • Georgetown University

    lead OTHER

Principal Investigators

  • Christopher Attinger, MD · MedStar Georgetown University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2020-09-30
Completion
2021-09-30
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 NCT03250442 on ClinicalTrials.gov