Preventing Pressure Ulcers in Veterans With Spinal Cord Injury (SCI)

This study has been terminated.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00105859
First received: March 17, 2005
Last updated: May 6, 2010
Last verified: June 2005
  Purpose

Pressure ulcers are a serious, costly, and life-long complication of spinal cord injury (SCI). Pressure ulcer prevalence has been estimated at between 17 and 33% among persons with SCI residing in the community. Epidemiological studies have found that 36-50% of all persons with SCI who develop pressure ulcers will develop a recurrence within the first year after initial healing (Carlson et al., 1992; Fuhrer et al., 1993; Goldstein, 1998; Niazi et al., 1997; Salzberg et al. 1998). Recurrence rates have ranged from 21% to 79%, regardless of treatment (Schryvers et al., 2000; Goodman et al., 1999; Niazi et al., 1997). Pressure ulcer treatment is expensive. Surgical costs associated with pressure ulcer treatment can exceed $70,000 per case (Braun et al., 1992). VA administrative (National Patient Care Database, NPCD) data indicate that 41% of inpatient days in the SCI population are accounted for by either primary or secondary diagnoses of pressure ulcers or 23% of SCI inpatient days if restricted to primary diagnoses of pressure ulcers. Pressure ulcer recurrence has been associated with many factors including previous pressure ulcer surgery (Niazi et al., 1997). Although little data exist describing the factors associated with recurrence following surgery, some investigators reported recurrence rates of 11%-29% in cases with post-operative complications and 6% to 61% in cases without post-operative complications (Mandrekas & Mastorakos, 1992; Relander & Palmer, 1988; Disa et al., 1992). In a retrospective study of 48 veterans with SCI, investigators reported a 79% recurrence rate following surgery (Goodman et al., 1999).


Condition Intervention
Spinal Cord Injury
Pressure Ulcers
Behavioral: Education and Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preventing Pressure Ulcers in Veterans With Spinal Cord Injury (SCI)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 278
Arms Assigned Interventions
1 Behavioral: Education and Counseling

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

SCI more than 1 year duration, admitted to VA for treatment of a stage III or IV pressure ulcer, access to telephone for follow-up, understands english, cognitively intact

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105859

Locations
United States, Georgia
VA Medical Center, Augusta
Augusta, Georgia, United States, 30904-6285
United States, Tennessee
Memphis, TN
Memphis, Tennessee, United States, 38104
United States, Texas
Houston VA Medical Center
Houston, Texas, United States, 77030
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
United States, Wisconsin
Clement J. Zablocki VAMC
Milwaukee, Wisconsin, United States, 53295-1000
Sponsors and Collaborators
Investigators
Principal Investigator: Susan Garber, MA BS Houston VA Medical Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Garber, Susan - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00105859     History of Changes
Other Study ID Numbers: IIR 01-151
Study First Received: March 17, 2005
Last Updated: May 6, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Pressure Ulcer
Spinal Cord Injuries
Ulcer
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Skin Diseases
Skin Ulcer
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 21, 2014