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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02272881
Recruitment Status : Withdrawn (We have not been able to enroll patients.)
First Posted : October 23, 2014
Last Update Posted : June 12, 2018
Information provided by (Responsible Party):
Santa Barbara Cottage Hospital

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.

Condition or disease Intervention/treatment Phase
Pressure Ulcer Procedure: surgical reconstruction Procedure: wound management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: immediate surgical intervention
immediate surgical reconstruction of the pressure ulcer via flap closure or comparable procedure
Procedure: 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.

wound care
conservative wound management directed by certified wound care experts
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.

Primary Outcome Measures :
  1. Wound Closure [ Time Frame: 6 months after randomization ]
    measured by intact skin at the original ulcer site

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Santa Barbara Cottage Hospital Identifier: NCT02272881    
Other Study ID Numbers: 14-42r
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases