Enhancement of Pressure Healing With Pulsatile Lavage

September 10, 2015 updated by: US Department of Veterans Affairs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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). It will investigate the hypothesis that the treatment of non-necrotic pressure ulcers with pulsatile lavage will enhance the rate of healing.

These 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 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.

Methodology Eligible individuals with SCI who are admitted to CVAMC with pelvic region pressure ulcers will be assigned to a pulsatile lavage treatment group or to a second non-intervention control group. A comprehensive assessment methodology will be employed to characterize pressure ulcer healing. All study participants will be assessed at routine intervals using objective measurement techniques. Statistical analysis of inter-group differences will allow the efficacy of pulsatile lavage for pressure ulcer healing to be established. Forty subjects will be enrolled in the study.

Patient Selection Criteria: 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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • VA Medical Center, Cleveland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Spinal Cord Injury

Exclusion Criteria:

systemic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulsatile lavage group
pulsatile lavage therapy
Procedure: Pulsatile Lavage
pulsatile lavage to wound bed
Sham Comparator: Sham lavage group
sham pulsatile lavage
Other: sham pulsatile lavage
pulsatile lavage to not directed at wound or patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure Ulcer Geometry
Time Frame: study participation - up to 6 weeks
Linear assessment of wounds
study participation - up to 6 weeks
Pressure Ulcer Volume Measurement
Time Frame: study participation - up to 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Chester H. Ho, MD, VA Medical Center, Cleveland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

October 9, 2002

First Submitted That Met QC Criteria

October 9, 2002

First Posted (Estimate)

October 10, 2002

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

September 10, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2803-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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