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

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03250442
• Other study ID #: 2017-0599
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: September 2021

Study information

• Verified date: September 2019
• Source: Georgetown University
• Contact: Christopher Attinger, MD
• Phone: 202-444-8780
• Email: christopher.attinger[@]medstar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amputation
• Surgical Wound
• Wound Heal
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of hospital stay	The amount of time the patients must stay after closure surgery.	5 days
Secondary	Number of surgically related wound readmissions	The number of times patients are readmitted to the hospital for their surgical wound post-discharge.	95 days
Secondary	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
Secondary	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