Unexpected Positive Cultures in Rotator Cuff Revision Surgery

NARecruitingINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

February 27, 2024

Primary Completion Date

February 15, 2028

Study Completion Date

March 15, 2028

Conditions
Rotator Cuff Repair
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."

Trial Locations (8)

14050

NOT_YET_RECRUITING

Hôpital privé Saint-Martin, Caen

31600

NOT_YET_RECRUITING

Clinique d'occitanie ELSAN, Muret

44800

NOT_YET_RECRUITING

Santé Atlantique ELSAN, Saint-Herblain

54270

NOT_YET_RECRUITING

Clinique Louis Pasteur, Essey-lès-Nancy

63110

NOT_YET_RECRUITING

Hôpital privé La Châtaigneraie ELSAN, Beaumont

69008

NOT_YET_RECRUITING

Santy-Lyon-Ramsay, Lyon

06000

NOT_YET_RECRUITING

ICR-Kantys, Nice

Unknown

RECRUITING

Clinique de l'Orangerie, Strasbourg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Elsan

OTHER

NCT06257979 - Unexpected Positive Cultures in Rotator Cuff Revision Surgery | Biotech Hunter | Biotech Hunter