Clinical Trial: BION Active Seating for Pressure Ulcer Prevention

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: BION Active Seating for Pressure Ulcer Prevention

Brief Summary:

Pressure ulcers (PUs) are a debilitating pathology resulting from pressure and shear in the soft tissues of immobilized patients. In studies to date, BION neuromuscular stimulation has been demonstrated to activate strong muscle contractions and to produce skeletal motion, with associated increases in muscle bulk (hypertrophy), strength, and metabolic capacity, hence counteracting the 3 major etiological factors in PU development (immobility, soft-tissue atrophy and hypoxia).

This study intends to use neuromuscular stimulation to both shift paralyzed subjects' weight and build up gluteal muscle volume, in order to prevent recurrence of pressure ulcers. We will implant BIONs alongside the already exposed inferior gluteal and sciatic nerves in patients who are undergoing gluteal rotation flap surgery for PU reconstruction. The gluteal rotation flap is a common reconstructive technique for treating PUs by bringing healthy muscle and skin in to repair the deficient area, and to provide healthy tissue covering over bony prominences. The implanted BIONs will enable us subsequently to stimulate the gluteus maximus and hip extensor muscles. Outcome measures will include tissue health variables (measured by clinical assessment, X-Rays, MRI and Sesta-MIBI SPECT perfusion scans), pressure redistribution (measured by an array of pressure sensors), and recurrence rates over 12 months.

Detailed Summary:
Sponsor: University of Southern California

Current Primary Outcome: Clinical assessment of movement and shifting of weight during BAS. Record shifts in pressure distribution over seated pressure points during NMES. [ Time Frame: upon discharge and at the 12-week, 20-week, 36-week and 52-week outpatient follow-up visits. ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Clinical Examination of Braden Scale assessment,Reperfusion time,Recurrence of wounds and Body Mass Index [ Time Frame: preoperation, upon removal of sutures, upon discharge, and at the 12-week, 20-week, 36-week and 52-week outpatient follow-up visits. ]

Original Secondary Outcome: Same as current

Information By: University of Southern California

Dates:
Date Received: February 25, 2008
Date Started: November 2007
Date Completion:
Last Updated: June 1, 2015
Last Verified: June 2015