Investigation of Subatmospheric Pressure Dressing on Pressure Ulcer Healing

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00011531
First received: February 22, 2001
Last updated: February 5, 2009
Last verified: January 2001
  Purpose

Many spinal cord injury (SCI) and otherwise debilitated patients develop pressure ulcers over the course of their injury or disease. Despite enhanced wound care management, many pressure ulcers do not heal completely and require surgical myocutaneous rotational flap coverage. Even then they often recur.

The objectives of this study are: (1) to conduct a controlled comparative study of the effectiveness of subatmospheric pressure dressing (SPD) in healing pressure ulcers versus conventional saline wet-to-moist dressing techniques; (2) to establish indications and contra-indications for use of SPD In treating pressure ulcers; and (3) to develop a noninvasive, clinically usable optical digitizer and associated software for measurement of wound geometry for standardized quantitative assessment and longitudinal monitoring of wound healing.


Condition Intervention Phase
Diabetic Foot Ulcers
Procedure: Prevention of Pressure Ulcers
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of Subatmospheric Pressure Dressing on Pressure Ulcer Healing

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 120
Study Start Date: January 2000
Study Completion Date: December 2001
Arms Assigned Interventions
1 Procedure: Prevention of Pressure Ulcers

Detailed Description:

Many spinal cord injury (SCI) and otherwise debilitated patients develop pressure ulcers over the course of their injury or disease. Despite enhanced wound care management, many pressure ulcers do not heal completely and require surgical myocutaneous rotational flap coverage. Even then they often recur.

HYPOTHESIS: Subatmospheric pressure dressing (SPD) treatment applied to pressure ulcers will either completely close them, or heal to a point allowing for skin graft coverage, more often than 0.9% normal saline wet-to-moist dressing (WTMD) treatment.

OBJECTIVES: The objectives of this study are: (1) to conduct a controlled comparative study of the effectiveness of subatmospheric pressure dressing (SPD) in healing pressure ulcers versus conventional saline wet-to-moist dressing techniques; (2) to establish indications and contra-indications for use of SPD In treating pressure ulcers; and (3) to develop a noninvasive, clinically usable optical digitizer and associated software for measurement of wound geometry for standardized quantitative assessment and longitudinal monitoring of wound healing.

RESEARCH METHODS: 120 patients with stage III or IV pressure ulcers meeting the project selection criteria will be recruited for the project. Patients will be randomly assigned in a 3:1 (SPD to WTMD) ratio to either the control group receiving 0.9% normal saline wet-to-moist wound dressing and treatment, or to the subatmospheric pressure dressing group. All subjects selected will be further stratified according to degree of wound severity, nutritional status, and evidence of wound infection. The WTMD group will receive 0.9% NS moistened gauze applied to the wound, which will be changed every 8 hours. The SPD group will receive SPD dressing with the VACTM system set at a constant subatmospheric pressure of negative 125 mmHg. The SPD device and dressing will be left in place and changed every Monday, Wednesday, and Friday. The subjects' pressure ulcers will be measured on day 0 and then on a weekly basis. Ulcer surface shape, area, and coloration will be recorded with a digital camera and also by tracing the ulcer perimeter on a flexible translucent plastic film with grid overlaid on the wound. In addition, an optical laser scanner will used to record ulcer shape, area, and coloration, and body/limb segmental volume in the region of the wound. Volume will also be measured using alginate wound impressions to form RTV silicone molds for fluid displacement measurement. The molds of the wounds will also be optically digitized and wound perimeter, topical surface area, total 3-D surface area, and volume calculated using computer image processing, planimetry, and volumetry software developed in the project. Local body/limb segment volume will also be calculated to monitor edematous fluctuations. Based on these measurements, the wound responses will be scored as described in Table 2 after one month or at the time of the patient's withdrawal from the study. The association between response level and treatment type will be analyzed using Chi-square test of association. Mantel-Haenszel Chi-square and logistic regression will be used to control for prognostic variables.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria:

  • Wounds and ulcers

Exclusion Criteria:

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011531

Locations
United States, New York
New York Harbor HCS
New York, New York, United States, 10010
Sponsors and Collaborators
Investigators
Principal Investigator: Michael Longaker, MD New York Harbor HCS
  More Information

No publications provided

Responsible Party: Longaker, Michael - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00011531     History of Changes
Other Study ID Numbers: B2108R
Study First Received: February 22, 2001
Last Updated: February 5, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Decubitus Ulcers
dehiscence
SCI
wound healing

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Foot Ulcer
Diabetic Foot
Skin Ulcer
Skin Diseases
Pathologic Processes
Foot Diseases
Leg Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on July 20, 2014