Status:
UNKNOWN
Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Amputations
Lead Sponsor:
Georgetown University
Conditions:
Surgical Wound
Wound Heal
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03250442
Start Date
November 1 2017
End Date
September 1 2021
Last Update
September 25 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007