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

NCT ID: NCT02272881

Last Updated: 2018-06-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2018-06-30

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.

Conditions

Pressure Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

immediate surgical intervention

immediate surgical reconstruction of the pressure ulcer via flap closure or comparable procedure

Group Type: EXPERIMENTAL

surgical reconstruction

Intervention Type: PROCEDURE

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.

wound care

conservative wound management directed by certified wound care experts

Group Type: OTHER

wound management

Intervention Type: PROCEDURE

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.

Interventions

surgical reconstruction

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.

Intervention Type: PROCEDURE

wound management

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santa Barbara Cottage Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

14-42r

Identifier Type: -

Identifier Source: org_study_id