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

Not Applicable

• Conditions: Wound Heal; Surgical Wound; Amputation
• Interventions: Other: Standard Dry Dressing; Device: PrevenaTM Device

• Registration Number: NCT03250442
• Lead Sponsor: Georgetown University

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.

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 Timeline

• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-11
• Study First Posted: 2017-08-15
• Study Start: 2017-11-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25
• Primary Completion: 2020-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Standard Dry Dressing	Standard Dry Dressing	The standard dry dressing is comprised of nonadherent dressing, dry gauze, cotton undercast padding, compression, and immobilization.
Group B: Foam, Drape, and PrevenaTM	PrevenaTM Device	This arm is comprised of foam, drape, the PrevenaTM Device, compression, and immobilization.

Primary Outcome Measures

Name	Time	Method
Proportion of postoperative incision complications between the 2 arms	95 days	The proportion of issues that arise between the two groups after closure surgery.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medstar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States