NCT03250442

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Surgical Wound
• Wound Heal
• Amputation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-01
• Primary completion: 2020-09-01
• Completion: 2021-09-01
• First posted: 2017-08-15
• Last updated: 2019-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study