Enhancement of Pressure Healing With Pulsatile Lavage

• Sponsor: US Department of Veterans Affairs (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00047619
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 71
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury	Procedure: Pulsatile Lavage; Other: sham pulsatile lavage	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Enhancement of Pressure Healing With Pulsatile Lavage
• Study Start Date: Jun 1, 2002
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pressure Ulcer Geometry [study participation - up to 6 weeks]

   Linear assessment of wounds

2. Pressure Ulcer Volume Measurement [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Spinal Cord Injury

Exclusion Criteria:

systemic disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Medical Center, Cleveland	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• US Department of Veterans Affairs

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: US Department of Veterans Affairs
• ClinicalTrials.gov Identifier: NCT00047619
• Other Study ID Numbers: A2803-R
• First Posted: Oct 10, 2002
• Last Update Posted: Oct 5, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by US Department of Veterans Affairs: Decubitus Ulcers; Pulsatile Lavage; SCI; Spinal Cord Injury; Wound healing; pressure ulcer
• Additional relevant MeSH terms: Spinal Cord Injuries

Study Results

Participant Flow

Arm/Group Title	Pulsatile Lavage Group	Sham Lavage Group
Arm/Group Description	pulsatile lavage therapy Pulsatile Lavage: pulsatile lavage to wound bed	sham pulsatile lavage sham pulsatile lavage: pulsatile lavage to not directed at wound or patient
Period Title: Overall Study
STARTED	14	14
COMPLETED	14	14
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Pulsatile Lavage Group	Sham Lavage Group	Total
Arm/Group Description	pulsatile lavage therapy Pulsatile Lavage: pulsatile lavage to wound bed	sham pulsatile lavage sham pulsatile lavage: pulsatile lavage not directed at wound or patient	Total of all reporting groups
Overall Participants	14	14	28
Age, Customized (participants) [Number]
Number of subjects >=18 years	14 100%	14 100%	28 100%
Sex/Gender, Customized (participants) [Number]
male gender	14 100%	14 100%	28 100%

Outcome Measures

1. Primary Outcome

Title	Pressure Ulcer Geometry
Description	Linear assessment of wounds
Time Frame	study participation - up to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pulsatile Lavage Group	Sham Lavage Group
Arm/Group Description	pulsatile lavage therapy Pulsatile Lavage: pulsatile lavage to wound bed	sham pulsatile lavage sham pulsatile lavage: pulsatile lavage to not directed at wound or patient
Measure Participants	14	14
Length in cm	3.5	4.9
Width in cm	2.9	3.0
Depth in cm	1.4	2.5

2. Primary Outcome

Title	Pressure Ulcer Volume Measurement
Description	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
Time Frame	study participation - up to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pulsatile Lavage Group	Sham Lavage Group
Arm/Group Description	pulsatile lavage therapy Pulsatile Lavage: pulsatile lavage to wound bed	sham pulsatile lavage sham pulsatile lavage: pulsatile lavage to not directed at wound or patient
Measure Participants	14	14
Mean (95% Confidence Interval) [cm^3]	5.8	12.4

Adverse Events

Time Frame	Duration of study
Arm/Group Title	Pulsatile Lavage Group		Sham Lavage Group
Arm/Group Description	pulsatile lavage therapy Pulsatile Lavage: pulsatile lavage to wound bed		sham pulsatile lavage sham pulsatile lavage: pulsatile lavage to not directed at wound or patient
All Cause Mortality
	Pulsatile Lavage Group		Sham Lavage Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pulsatile Lavage Group		Sham Lavage Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Pulsatile Lavage Group		Sham Lavage Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.