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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2021-09-30

Brief Summary

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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.

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Detailed Description

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Incisional negative pressure wound therapy is an approved device used for wound healing of closed surgical incisions. This research is being done because incisional negative pressure wound therapy is a new application of negative pressure wound therapy that is applied over a closed incision area instead of an open wound. Negative pressure wound therapy is commonly used to help heal open wounds. It involves the use of a piece of foam, an adhesive drape, and a battery-powered device that places negative pressure on the wound. Currently, there are no trials utilizing incisional negative pressure wound therapy of closed wounds after below knee amputations (BKA), transmetatarsal amputations (TMA), Knee Disarticulations (KD), and Above Knee Amputations (AKA). This is a pilot study that compares incisional negative pressure wound therapy and standard dressings in patients.

Conditions

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Surgical Wound Wound Heal Amputation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: Standard Dry Dressing

The standard dry dressing is comprised of nonadherent dressing, dry gauze, cotton undercast padding, compression, and immobilization.

Group Type OTHER

Standard Dry Dressing

Intervention Type OTHER

These are customary dry dressings.

Group B: Foam, Drape, and PrevenaTM

This arm is comprised of foam, drape, the PrevenaTM Device, compression, and immobilization.

Group Type ACTIVE_COMPARATOR

PrevenaTM Device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Standard Dry Dressing

These are customary dry dressings.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Must be at least 18 years or older to participate.
2. Requires closure of a nontrauamtic Transmetatarsal Amputation (TMA), Below Knee Amputation (BKA), Knee Disarticulation (KD), or Above Knee Amputation (AKA).
3. Has at least one artery that feeds the closure site.
4. Able to comply with clinical trial procedures and schedule.

Exclusion Criteria

1. Patients not receiving an amputation.
2. The investigator/provider determines that the patient has an indication against incisional negative pressure wound therapy that would prevent them from participating.
3. Surgical incision that is not completely closed.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes