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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00105859 |
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 |
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Spinal Cord Injury Pressure Ulcers |
Behavioral: Education and Counseling |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Preventing Pressure Ulcers in Veterans With Spinal Cord Injury (SCI) |
Estimated Enrollment: | 278 |
Arms | Assigned Interventions |
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1 | Behavioral: Education and Counseling |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
United States, Georgia | |
VA Medical Center, Augusta | |
Augusta, Georgia, United States, 30904-6285 | |
United States, Illinois | |
Edward Hines, Jr. VA Hospital | |
Hines, Illinois, United States, 60141-5000 | |
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 |
Principal Investigator: | Susan Garber, MA BS | Houston VA Medical Center |
Responsible Party: | Department of Veterans Affairs ( Garber, Susan - Principal Investigator ) |
Study ID Numbers: | IIR 01-151 |
Study First Received: | March 17, 2005 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00105859 |
Health Authority: | United States: Federal Government |
Spinal Cord Injuries Spinal Cord Diseases Skin Diseases Ulcer Wounds and Injuries |
Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System Skin Ulcer Pressure Ulcer |
Pathologic Processes Nervous System Diseases |