Investigation of Subatmospheric Pressure Dressing on Pressure Ulcer Healing
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2000
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedFirst Submitted
Initial submission to the registry
February 22, 2001
CompletedFirst Posted
Study publicly available on registry
February 26, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2001
CompletedFebruary 9, 2009
January 1, 2001
February 22, 2001
February 5, 2009
Conditions
Keywords
Study Arms (1)
1
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Wounds and ulcers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York Harbor HCS
New York, New York, 10010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Longaker, MD
New York Harbor HCS
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
February 22, 2001
First Posted
February 26, 2001
Study Start
January 1, 2000
Study Completion
December 1, 2001
Last Updated
February 9, 2009
Record last verified: 2001-01