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Unexpected Positive Cultures in Rotator Cuff Revision Surgery
Sponsor: Elsan
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
Conditions
Interventions
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