NCT00105859

Brief Summary

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2005

Completed
Last Updated

May 10, 2010

Status Verified

June 1, 2005

First QC Date

March 17, 2005

Last Update Submit

May 6, 2010

Conditions

Study Arms (1)

1

OTHER
Behavioral: Education and Counseling

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

VA Medical Center, Augusta

Augusta, Georgia, 30904-6285, United States

Location

Memphis, TN

Memphis, Tennessee, 38104, United States

Location

Houston VA Medical Center

Houston, Texas, 77030, United States

Location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Clement J. Zablocki VAMC

Milwaukee, Wisconsin, 53295-1000, United States

Location

Related Publications (3)

  • 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. doi: 10.1016/j.apmr.2007.03.014.

  • 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. doi: 10.1080/10790268.2008.11754570.

  • Guihan M, Bombardier CH. Potentially modifiable risk factors among veterans with spinal cord injury hospitalized for severe pressure ulcers: a descriptive study. J Spinal Cord Med. 2012 Jul;35(4):240-50. doi: 10.1179/2045772312Y.0000000016.

MeSH Terms

Conditions

Spinal Cord InjuriesPressure Ulcer

Interventions

Educational StatusCounseling

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Susan Garber, MA BS

    Michael E. DeBakey VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

March 17, 2005

First Posted

March 18, 2005

Last Updated

May 10, 2010

Record last verified: 2005-06

Locations