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

Santa Barbara Cottage Hospital

Status

Withdrawn

Conditions

Pressure Ulcer

Treatments

Procedure: wound management

Procedure: surgical reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT02272881

14-42r

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.