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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Procedure: surgical reconstruction
* Procedure: wound management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate surgical intervention<br>immediate surgical reconstruction of the pressure ulcer via flap closure or comparable procedure | Procedure: surgical reconstruction<br>* Patients randomized to surgical flap closure will undergo reconstructive plastic surgery to close an intended pressure ulcer at the earliest date after selection. Our group's co-investigator and staff plastic and reconstructive surgeon will decide on the optimal technical repair. Given the lack of retrospective evidence to support a superior surgical repair (myocutaneous, fasciocutaneous, local flap arrangement versus free microvascular tissue transfer) we will defer to our physician staff preference on a per patient basis. The time from enrollment to surgical intervention will be tracked, and no patient will be dropped from the study should this time exceed the two-week ideal.<br>|
| Other: wound care<br>conservative wound management directed by certified wound care experts | Procedure: wound management<br>* Patients selected to the supportive wound care arm will be managed by the Center for Wound Care at Cottage Health System, a certified wound care center. They will receive standard of care conservative wound care including: debridement, dressing changes, wound checks, physical therapy, occupational therapy, antibiotic treatment, nutritional support and close follow-up over the study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Closure | measured by intact skin at the original ulcer site | 6 months after randomization |