A Randomized, Prospective Clinical Trial of Immediate Flap Closure Versus Wound Care for Management of Late-stage Pressure Ulcers
Not Applicable
Withdrawn
- Conditions
- Pressure Ulcer
- Registration Number
- NCT02272881
- Lead Sponsor
- Santa Barbara Cottage Hospital
- Brief Summary
The purpose of this study is to compare the number of and degree of pressure ulcers healed, as measured by intact skin at the original ulcer site at 6 months of follow-up in patients randomized to immediate operative closure versus those who are maintained in a wound care program in patients with Stage 3 and 4 sacral and peri-sacral decubitus ulcers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- At least 18 years old;
- Stage III or IV pressure ulcers on or near trochanter, ischium, sacrum or buttocks;
- Receiving treatment at the Center for Wound Management - Goleta Valley Cottage Hospital; Santa Barbara Cottage Hospital or Santa Ynez Cottage Hospital, all part of Cottage Health System;
- Underlying etiology for immobility secondary to spinal cord injury (SCI) or other neuromuscular condition not expected to become progressive in next 12 months;
- No contraindications to undergo surgical intervention, including medical ability to tolerate surgical procedure with general anesthesia.
Exclusion Criteria
- Unable or unwilling to provide informed consent;
- Underlying cause of immobility secondary to chronic medical disease outside of nonprogressive SCI or neuromuscular disease as described above;
- Patients requiring immediate surgical closure determined by physician judgment;
- Those deemed inappropriate to consider for surgery outside of study; potential reasons normally include medical comorbidities, inability to comply with post-operative care, and lack of funding source for elective procedure, peri-operative, and / or wound care.
- Patients who have already been receiving active, professionally supervised wound care for > 2 week period prior to presentation
- Patient is pregnant or breastfeeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Wound Closure 6 months after randomization measured by intact skin at the original ulcer site
- Secondary Outcome Measures
Name Time Method