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NCT04446936 Clinical Trial

Comparing Different Surgical Techniques for Coverage of Pressure Ulcer

Pressure Ulcer Clinical Trial

Official title:
A Retrospective Study Comparing Failure and Complications Rates Between Propeller Flap and Random Flap for Pressure Ulcer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04446936
Other study ID # RECHMPL20_0366
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 1, 2020
Est. completion date January 20, 2021

Study information
Verified date December 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date January 20, 2021
Est. primary completion date December 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Flap covering for pressure ulcer
Flap covering for pressure ulcer

Locations
Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Failure rate Comparing failure rates between the two surgical techniques 1 day
Secondary Complications rate Comparing complications rate between the two surgical techniques 1 day
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