A Randomized, Prospective Clinical Trial of Immediate Flap Closure Versus Wound Care for Management of Late-stage Pressure Ulcers

The Santa Barbara Pressure Ulcer Study Comparison of Immediate Flap Closure Versus Wound Care for Management of Late-stage Pressure Ulcers: a Randomized, Prospective Clinical Trial

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.

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.