Spinal Cord Injury Clinical Trial
Official title:
Preventing Pressure Ulcers in Veterans With Spinal Cord Injury (SCI)
NCT number | NCT00105859 |
Other study ID # | IIR 01-151 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | March 17, 2005 |
Last updated | May 6, 2010 |
Verified date | June 2005 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 278 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | VA Medical Center, Augusta | Augusta | Georgia |
United States | Houston VA Medical Center | Houston | Texas |
United States | Memphis, TN | Memphis | Tennessee |
United States | Clement J. Zablocki VAMC | Milwaukee | Wisconsin |
United States | Hunter Holmes McGuire VA Medical Center | Richmond | Virginia |
United States | VA Puget Sound Health Care System, Seattle | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Guihan M, Garber SL, Bombardier CH, Durazo-Arizu R, Goldstein B, Holmes SA. Lessons learned while conducting research on prevention of pressure ulcers in veterans with spinal cord injury. Arch Phys Med Rehabil. 2007 Jul;88(7):858-61. — View Citation
Guihan M, Garber SL, Bombardier CH, Goldstein B, Holmes SA, Cao L. Predictors of pressure ulcer recurrence in veterans with spinal cord injury. J Spinal Cord Med. 2008;31(5):551-9. — View Citation
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