Comparing Different Surgical Techniques for Coverage of Pressure Ulcer

NCT04446936 | Unknown

• 1 other identifier: RECHMPL20_0366
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pressure Ulcer

Keywords

Ulcer; Flap; Random; Propeller; Paraplegic; Surgery

Outcome Measures

Primary Outcomes (1)

• Failure rate

  Comparing failure rates between the two surgical techniques

  1 day

Secondary Outcomes (1)

• Complications rate

  1 day

Study Arms (2)

Propeller flaps

Patients who undergone propeller flap surgery

Procedure: Flap covering for pressure ulcer

Random flaps

Patients who undergone random flap surgery

Procedure: Flap covering for pressure ulcer

Interventions

Flap covering for pressure ulcer PROCEDURE

Flap covering for pressure ulcer

Propeller flaps; Random flaps

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with sacral, trochanteric or ischiatic pressure ulcer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Pressure Ulcer; Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Farid BEKARA, MD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 25, 2020
• Study Start: August 1, 2020
• Primary Completion: December 20, 2020
• Study Completion: January 20, 2021
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

FR (1)