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Investigation of Subatmospheric Pressure Dressing on Pressure Ulcer Healing

NCT00011531 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2009-02-09

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcers

Interventions

PROCEDURE

Prevention of Pressure Ulcers

Sponsors & Collaborators

Principal Investigators

  • Michael Longaker, MD · New York Harbor HCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-31
Completion
2001-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00011531 on ClinicalTrials.gov