Status:
WITHDRAWN
A Randomized, Prospective Clinical Trial of Immediate Flap Closure Versus Wound Care for Management of Late-stage Pressure Ulcers
Lead Sponsor:
Santa Barbara Cottage Hospital
Conditions:
Pressure Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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 imm...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02272881
Start Date
December 1 2014
End Date
June 1 2018
Last Update
June 12 2018
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