Pressure UlcerNCT04446936
Comparing Different Surgical Techniques for Coverage of Pressure Ulcer
An observational study of Pressure Ulcer, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The Plastic, Reconstructive and Aesthetic Surgery department of Montpellier was born out of the Wound and Healing department, the first unit of this type to be created in Europe. The investigators quickly became the national leader in the management of pressure ulcers, especially in people with spinal cord injuries. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Flap covering for pressure ulcer
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2020to 20 Jan 2021
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sacral, trochanteric or ischiatic pressure ulcer
Who may be able to join
- Major Patient
- Patient with trochanteric, ischiatic or sacral pressure ulcer
- Patient who undergone flap surgery for pressure ulcer between January 1st, 2015 and December 31st, 2019
Who cannot join
- Other loss of substance than pressure ulcer
- Combined covering with a random flap and a propeller flap
- Surgical revision of a flap without a new flap
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study Comparing Failure and Complications Rates Between Propeller Flap and Random Flap for Pressure Ulcer
The Plastic, Reconstructive and Aesthetic Surgery department of Montpellier was born out of the Wound and Healing department, the first unit of this type to be created in Europe. The investigators quickly became the national leader in the management of pressure ulcers, especially in people with spinal cord injuries.
Our expertise has evolved over time as well as our surgical techniques for covering ulcers, gradually over time the investigators have gone from " random " flaps to " propeller " flaps, more reliable in terms of vascularization and more logical in terms of force distribution and skin tension.
The investigators found subjectively that the rate of complications was lower for the helical flaps. The investigators therefore seek to confirm this trend through a retrospective study on patients operated on in the department between January 1, 2015 and December 31, 2019.
- Conditions
- Pressure Ulcer
- Being tested
- Flap covering for pressure ulcer
- Keywords
- Ulcer, Flap, Random, Propeller, Paraplegic, Surgery
- Medical subject headings
- Pressure Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flap covering for pressure ulcerProcedure or surgery
Flap covering for pressure ulcer
| Study group | Role | What they receive |
|---|---|---|
| Propeller flaps | Patients who undergone propeller flap surgery Receives: Procedure: Flap covering for pressure ulcer | |
| Random flaps | Patients who undergone random flap surgery Receives: Procedure: Flap covering for pressure ulcer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure rate
Comparing failure rates between the two surgical techniques
Measured: 1 day
Secondary outcomes (1)
Complications rate
Comparing complications rate between the two surgical techniques
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Aug 2020
- Primary completion20 Dec 2020
- Study completion20 Jan 2021 (estimated)
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.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farid BEKARA, MD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446936
- Sponsor's protocol ID
- RECHMPL20_0366
- Status last verified
- Dec 2020
- First submitted
- 22 Jun 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Comparing Failure and Complications Rates Between Propeller Flap and Random Flap for Pressure Ulcer
- ClinicalTrials.gov ID
- NCT04446936
- Acronym / sponsor ID
- RECHMPL20_0366
- Conditions
- Pressure Ulcer
- Keywords
- Ulcer, Flap, Random, Propeller, Paraplegic, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Jan 2021 (estimated)
- First posted
- 25 Jun 2020 (actual)
- 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 Plastic, Reconstructive and Aesthetic Surgery department of Montpellier was born out of the Wound and Healing department, the first unit of this type to be created in Europe. The investigators quickly became the national leader in the management of pressure ulcers, especially in people with spinal cord injuries.
Our expertise has evolved over time as well as our surgical techniques for covering ulcers, gradually over time the investigators have gone from " random " flaps to " propeller " flaps, more reliable in terms of vascularization and more logical in terms of force distribution and skin tension.
The investigators found subjectively that the rate of complications was lower for the helical flaps. The investigators therefore seek to confirm this trend through a retrospective study on patients operated on in the department between January 1, 2015 and December 31, 2019.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propeller flaps | – | Procedure: Flap covering for pressure ulcerPatients who undergone propeller flap surgery |
| Random flaps | – | Procedure: Flap covering for pressure ulcerPatients who undergone random flap surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sacral, trochanteric or ischiatic pressure ulcer
Key inclusion criteria (3 listed)
- Major Patient
- Patient with trochanteric, ischiatic or sacral pressure ulcer
- Patient who undergone flap surgery for pressure ulcer between January 1st, 2015 and December 31st, 2019
Key exclusion criteria (3 listed)
- Other loss of substance than pressure ulcer
- Combined covering with a random flap and a propeller flap
- Surgical revision of a flap without a new flap
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 |
|---|---|---|
| Flap covering for pressure ulcerFlap covering for pressure ulcer | Procedure or surgery | Propeller flaps, Random flaps |
Primary outcome
Failure rate
Time frame: 1 day
Comparing failure rates between the two surgical techniques
1 secondary outcome
Complications rate
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Pressure Ulcer
RecruitingPhase 4
Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care in the Management of Nonhealing Pressure Ulcers
Pressure Ulcer, Ulcer, Pressure
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
Recruiting
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
Spinal Cord Injuries, Pressure Injuries
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Not yet recruitingObservational study
Explainable AI for Prospective Pressure Injury Staging
Pressure Injury
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.
Farid BEKARA, MD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer, run by University Hospital, Montpellier at 1 site in France.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Failure rate (time frame: 1 day). 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 29 Dec 2020.