Pressure UlcerNCT02272881
A Randomized, Prospective Clinical Trial of Immediate Flap Closure Versus Wound Care for Management of Late-stage Pressure Ulcers
A study testing surgical reconstruction and wound management in people with Pressure Ulcer, run by Santa Barbara Cottage Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- surgical reconstruction and wound management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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
- Being tested
- surgical reconstruction, wound management
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical reconstructionProcedure or surgery
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 managementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| immediate surgical intervention | Experimental | immediate surgical reconstruction of the pressure ulcer via flap closure or comparable procedure Receives: Procedure: surgical reconstruction |
| wound care | Other | conservative wound management directed by certified wound care experts Receives: Procedure: wound management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure
measured by intact skin at the original ulcer site
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2018
- Study completionJun 2018
Why it stopped: We have not been able to enroll patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Barbara Cottage Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272881
- Sponsor's protocol ID
- 14-42r
- Status last verified
- Jun 2018
- First submitted
- 9 Oct 2014
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02272881
- Acronym / sponsor ID
- 14-42r
- Conditions
- Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We have not been able to enroll patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Santa Barbara Cottage HospitalUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate surgical intervention | Experimental | Procedure: surgical reconstructionimmediate surgical reconstruction of the pressure ulcer via flap closure or comparable procedure |
| wound care | Other | Procedure: wound managementconservative wound management directed by certified wound care experts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical reconstructionPatients 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. | Procedure or surgery | immediate surgical intervention |
| wound managementPatients 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. | Procedure or surgery | wound care |
Primary outcome
Wound Closure
Time frame: 6 months after randomization
measured by intact skin at the original ulcer site
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing surgical reconstruction and wound management in people with Pressure Ulcer, run by Santa Barbara Cottage Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Closure (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2018.