BIONs, for Improved Tissue Health and Pressure Sore Prevention

NCT00262457 | Withdrawn

• 1 other identifier: B3259-R
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to determine the feasibility of an implanted electrical stimulation system incorporating BION microstimulators for long term use to prevent tissue breakdown in high risk patients.

Conditions

Pressure Ulcers; Spinal Cord Injury

Keywords

electrical stimulation; Pressure Ulcers; Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Improvement of tissue health

  Not feasible

Study Arms (1)

Arm 1

OTHER

Device: Implanted gluteal electrical stimulation system

Interventions

Implanted gluteal electrical stimulation system DEVICE

Implanted electrical stimulation system incorporating BION microstimulators

Arm 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Motor and sensory complete spinal cord injury above the level T12.
• No open skin problems or hospitalizations during the three months prior to entrance into the study.

You may not qualify if:

• Age less than 18 years.
• Less than two years post-injury or loss of independent walking ability.
• More than three urinary tract infections in the previous year.
• Significant active systemic disease, e.g. heart disease, renal failure, diabetes.
• Abnormal nutritional status based on albumin and total protein levels at recruitment (3.0 for albumin, 6.0 for total protein).
• Osteomyelitis of the pelvic region, indicated by positive pelvic inlet X-ray from routine annual urologic examination or bone scan.
• Previous surgery in the perineal region that radically alters the basic anatomy, particularly regional innervation and blood supply, e.g. amputation, hemipelvectomy.
• Extensive lower motor neuron damage to motor nerves innervating the gluteal muscles or electrical excitability of gluteal muscles with lower motor neuron innervation insufficient to produce desired level of contraction.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Links

• Click here for more information about this study: BIONs, for Improved Tissue Health and Pressure Sore Prevention

MeSH Terms

Conditions

Pressure Ulcer; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kath M. Bogie, PhD

  VA Medical Center-Cleveland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2005
• First Posted: December 6, 2005
• Study Start: April 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

US (1)