Back to resultsA Randomized, Prospective Clinical Trial of Immediate Flap Closure Versus Wound Care for Management of Late-stage Pressure Ulcers
Primary Purpose
Pressure Ulcer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
surgical reconstruction
wound management
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcer
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
immediate surgical intervention
wound care
Arm Description
immediate surgical reconstruction of the pressure ulcer via flap closure or comparable procedure
conservative wound management directed by certified wound care experts
Outcomes
Primary Outcome Measures
Wound Closure
measured by intact skin at the original ulcer site
Secondary Outcome Measures
Full Information
NCT ID
NCT02272881
First Posted
October 9, 2014
Last Updated
June 8, 2018
Sponsor
Santa Barbara Cottage Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02272881
Brief Title
A Randomized, Prospective Clinical Trial of Immediate Flap Closure Versus Wound Care for Management of Late-stage Pressure Ulcers
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Why Stopped
We have not been able to enroll patients.
Study Start Date
December 2014 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santa Barbara Cottage Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
immediate surgical intervention
Arm Type
Experimental
Arm Description
immediate surgical reconstruction of the pressure ulcer via flap closure or comparable procedure
Arm Title
wound care
Arm Type
Other
Arm Description
conservative wound management directed by certified wound care experts
Intervention Type
Procedure
Intervention Name(s)
surgical reconstruction
Intervention Description
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
Intervention Name(s)
wound management
Intervention Description
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 Measure Information:
Title
Wound Closure
Description
measured by intact skin at the original ulcer site
Time Frame
6 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Prospective Clinical Trial of Immediate Flap Closure Versus Wound Care for Management of Late-stage Pressure Ulcers
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