MedDataX Logo

Comparing Different Surgical Techniques for Coverage of Pressure Ulcer

NCT ID: NCT04446936

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-01-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pressure Ulcer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Ulcer Flap Random Propeller Paraplegic Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Propeller flaps

Patients who undergone propeller flap surgery

Flap covering for pressure ulcer

Intervention Type PROCEDURE

Flap covering for pressure ulcer

Random flaps

Patients who undergone random flap surgery

Flap covering for pressure ulcer

Intervention Type PROCEDURE

Flap covering for pressure ulcer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Flap covering for pressure ulcer

Flap covering for pressure ulcer

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Farid BEKARA, MD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uhmontpellier

Montpellier, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RECHMPL20_0366

Identifier Type: -

Identifier Source: org_study_id