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RECRUITING
NCT06257979
NA

Unexpected Positive Cultures in Rotator Cuff Revision Surgery

Sponsor: Elsan

View on ClinicalTrials.gov

Summary

In the context of rotator cuff re-intervention, the impact of Unexpected Positive Cultures (UPC) is not documented, and their management has not been studied, particularly regarding indications for antibiotic therapy, which is currently not a consensus. A prospective interventional study will be implemented to compare the results of non-randomized patient samples, whether positive or negative, taken during rotator cuff re-intervention. The objective is to assess whether these samples do not affect clinical outcomes and tendon healing rates.

Official title: Unexpected Positive Cultures in Rotator Cuff Revision Surgery: Significance and Influence on Outcomes and Tendon Healing

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

132

Start Date

2024-02-27

Completion Date

2028-03-15

Last Updated

2024-06-18

Healthy Volunteers

No

Interventions

OTHER

This study is with minimal risk and minimal constraints due to the addition of questionnaires

In this study, the specific procedures compared to routine care are : * Considering the addition of questionnaires, this study will be prospective. Due to the use of bacteriological samples, it is considered as a minimal-risk research. * The research procedure involves a bacteriological analysis of operative elements (sutures placed during the first intervention, the product of tendon debridement, and the subacromial bursa (cleaning product)) used during the re-intervention. These usually discarded operative samples are collected for bacteriological analysis. * Antibiotic treatment cannot be prescribed immediately after the surgery and during the first month following this re-intervention (time for biofilm formation). As per the protocol, even a positive sample should not lead to the initiation of systematic antibiotic therapy. In the case of identification of a pathogenic microorganism, antibiotic therapy will be prescribed, leading to discontinuation of the study.

Locations (8)

Hôpital privé La Châtaigneraie ELSAN

Beaumont, France

Hôpital privé Saint-Martin

Caen, France

Clinique Louis Pasteur

Essey-lès-Nancy, France

Santy-Lyon-Ramsay

Lyon, France

Clinique d'occitanie ELSAN

Muret, France

ICR-Kantys

Nice, France

Santé Atlantique ELSAN

Saint-Herblain, France

Clinique de l'Orangerie

Strasbourg, France