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

NCT03250442 | Unknown FDA Device

• 1 other identifier: 2017-0599
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of postoperative incision complications between the 2 arms

  The proportion of issues that arise between the two groups after closure surgery.

  95 days

Secondary Outcomes (4)

• Length of hospital stay

  5 days

• Number of surgically related wound readmissions

  95 days

• Medical Outcomes Study 12 Short Form Health Survey (SF-12)

  95 days

• Percentage of closed incisions remained closed at 1, 2 and 3 months post-hospital discharge

  At 1, 2, and 3 months post-hospital discharge

Study Arms (2)

Group A: Standard Dry Dressing

OTHER

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

Other: Standard Dry Dressing

Group B: Foam, Drape, and PrevenaTM

ACTIVE COMPARATOR

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

Device: PrevenaTM Device

Interventions

PrevenaTM Device 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.

Group B: Foam, Drape, and PrevenaTM

Standard Dry Dressing OTHER

These are customary dry dressings.

Group A: Standard Dry Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Christopher Attinger, MD

  MedStar Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Attinger, MD

CONTACT

202-444-8780; christopher.attinger@medstar.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 15, 2017
• Study Start: November 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)