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Article History

Received: 11 March 2024

Accepted: 19 August 2024

First Online: 2 September 2024

Declarations

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: The sponsor and the investigating surgeons agree that this research will be carried out in accordance with Law No. 2004–806 of August 9, 2004, as well as in accordance with Good Clinical Practices (I.C.H. version 4 of May 1, 1996, and decision of November 24, 2006) and the Declaration of Helsinki. The research is conducted in accordance with this protocol, except in emergency situations requiring the implementation of specific therapeutic acts. The investigating surgeons will respect all aspects of the protocol, in particular with regard to the collection of consent and notification and follow-up of SAEs. The present study was approved by the committee “Sud-Ouest et Outre-Mer I” of the CPP (2020-A03214-35) on 15/03/2021.The patient will be informed orally and in writing through the information note about the objective of the research, the progress and duration of the study, the benefits, potential risks and constraints of the study as well as about the opinion given by the CPP (art. L.1122–1 CSP). The information note is supplemented with the information necessary to comply with the regulations on the protection of personal data (GDPR). The investigating surgeon must specify to the patient that they are totally free to accept or refuse their participation in the research and that they retain the right to withdraw from the study at any time for any reason without causing any prejudice, in particular professional one. The patient’s participation in the protocol will be mentioned in their medical file at the time of the inclusion visit. All patients will provide written informed consent signifying their agreement to participate in the research before any study-specific assessment or procedure is performed (Art.L1122-1–1 CSP). No compensation is provided for the participation in this study.

: Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on reasonable request.

: Thiebaud Biomedical Devices provided complimentary St’rim™ adipose tissue grafting system. The authors declare that they have no competing interests.