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

A Randomized Controlled Trial Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Lower Extremity Amputations: A Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Amputation; Surgical Wound; Wound Heal
• Intervention / Treatment: Other: Standard Dry Dressing; Device: PrevenaTM Device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Recruiting
      • MedStar Georgetown University Hospital
      • Contact: Paul Kim, DPM; Phone Number: 202-444-3059
      • Principal Investigator: Paul Kim, DPM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group A: Standard Dry Dressing; The standard dry dressing is comprised of nonadherent dressing, dry gauze, cotton undercast padding, compression, and immobilization.	Other: Standard Dry Dressing; These are customary dry dressings.
Active Comparator: Group B: Foam, Drape, and PrevenaTM; This arm is comprised of foam, drape, the PrevenaTM Device, compression, and immobilization.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	The amount of time the patients must stay after closure surgery.	5 days
Number of surgically related wound readmissions	The number of times patients are readmitted to the hospital for their surgical wound post-discharge.	95 days
Medical Outcomes Study 12 Short Form Health Survey (SF-12)	Change in quality of life from the start of the study to the end.	95 days
Percentage of closed incisions remained closed at 1, 2 and 3 months post-hospital discharge	The percentage of closed surgical wounds that remain closed after 1, 2 and 3 months after their closure surgery.	At 1, 2, and 3 months post-hospital discharge

Collaborators and Investigators

• Sponsor: Georgetown University
• Investigators: Principal Investigator: Christopher Attinger, MD, MedStar Georgetown University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 11, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 2017-0599

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes