COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00105859
Recruitment Status : Terminated
First Posted : March 18, 2005
Last Update Posted : May 10, 2010
Information provided by:
VA Office of Research and Development

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).

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Pressure Ulcers Behavioral: Education and Counseling Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Pressure Ulcers in Veterans With Spinal Cord Injury (SCI)

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
1 Behavioral: Education and Counseling

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00105859

Layout table for location information
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
US Department of Veterans Affairs
Layout table for investigator information
Principal Investigator: Susan Garber, MA BS VA Medical Center, Houston
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Garber, Susan - Principal Investigator, Department of Veterans Affairs Identifier: NCT00105859    
Other Study ID Numbers: IIR 01-151
First Posted: March 18, 2005    Key Record Dates
Last Update Posted: May 10, 2010
Last Verified: June 2005
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Pressure Ulcer
Wounds and Injuries
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Skin Ulcer
Skin Diseases