Enhancement of Pressure Healing With Pulsatile Lavage

NCT00047619 | Completed Phase 2 Results

• 1 other identifier: A2803-R
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the use of pulsatile lavage to enhance the healing of pressure ulcers in individuals with spinal cord injury (SCI). The goals will be achieved using a repeated-measures double-blinded randomized controlled study of individuals with SCI who have pelvic region pressure ulcers. A total of 60 subjects will be recruited to this study. Participants will be randomly assigned to a treatment or control group. Pulsatile lavage treatment will be administered to the treatment group daily for a 3 week period. The control group subjects will receive daily sham pulsatile lavage treatment for 3 weeks. All subjects will be monitored for a 3 week period and will continue to receive routine pressure ulcer care, i.e. dressings and bedrest with a regular turning regime during their participation in the study. All study participants will be monitored following the study period until complete closure of the pressure ulcer is achieved in order to determine total interval to final closure, including any surgical procedures required. In addition, the economic effects of pulsatile lavage treatment will be evaluated through monitoring of data collected in the Computerized Patient Record System (CPRS), including duration of admission, duration of total bedrest order and duration of treatment for pressure ulcer. This data will give an initial measure of the cost benefits that may be achieved with the use of pulsatile lavage for the treatment of pressure ulcers. Subjects will be recruited from the Louis Stokes Cleveland Veterans Affairs Medical Center (CVAMC). All individuals with spinal cord injury who are admitted to the SCI Unit with pelvic region pressure ulcers will be considered eligible for this study. Further selection criteria will be employed to screen potential participants as described below. On recruitment subjects will be randomly assigned to 2 groups of 20 subjects. The assessment methods employed will be the same for each volunteer. One group will participate in the pulsatile lavage intervention, the second group will act as controls.

Conditions

Spinal Cord Injury

Keywords

Decubitus Ulcers; Pulsatile Lavage; SCI; Spinal Cord Injury; Wound healing; pressure ulcer

Outcome Measures

Primary Outcomes (2)

• Pressure Ulcer Geometry

  Linear assessment of wounds

  study participation - up to 6 weeks

• Pressure Ulcer Volume Measurement

  Volume of pressure ulcer was measured by the amount of fluid that could be used to fill the pressure ulcer which was covered by an occlusive dressing

  study participation - up to 6 weeks

Study Arms (2)

Pulsatile lavage group

EXPERIMENTAL

pulsatile lavage therapy

Procedure: Pulsatile Lavage

Sham lavage group

SHAM COMPARATOR

sham pulsatile lavage

Other: sham pulsatile lavage

Interventions

Pulsatile Lavage PROCEDURE

pulsatile lavage to wound bed

Pulsatile lavage group

sham pulsatile lavage OTHER

pulsatile lavage to not directed at wound or patient

Sham lavage group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spinal Cord Injury

You may not qualify if:

• systemic disease

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Ho CH, Bensitel T, Wang X, Bogie KM. Pulsatile lavage for the enhancement of pressure ulcer healing: a randomized controlled trial. Phys Ther. 2012 Jan;92(1):38-48. doi: 10.2522/ptj.20100349. Epub 2011 Sep 23.

  PMID: 21949432 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Pressure Ulcer

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Chester Ho
• Organization: University of Calgary

chester.ho@albertahealthservices.ca

(403) 944 4620

Study Officials

• Chester H. Ho, MD

  VA Medical Center-Cleveland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2002
• First Posted: October 10, 2002
• Study Start: June 1, 2002
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: October 5, 2015
• Results First Posted: October 5, 2015

Record last verified: 2015-09

Locations

US (1)