Clinical trial NCT03250442: Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Amputations
Official title: A Randomized Controlled Trial Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Lower Extremity Amputations: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Wound
Wound Heal
Amputation
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of postoperative incision complications between the 2 arms
timeFrame: 95 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 5 days
measure: Number of surgically related wound readmissions
timeFrame: 95 days
measure: Medical Outcomes Study 12 Short Form Health Survey (SF-12)
timeFrame: 95 days
measure: Percentage of closed incisions remained closed at 1, 2 and 3 months post-hospital discharge
timeFrame: At 1, 2, and 3 months post-hospital discharge
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
Study officials:
affiliation: MedStar Georgetown University Hospital
name: Christopher Attinger, MD
role: PRINCIPAL_INVESTIGATOR
References: