Unexpected Positive Cultures in Rotator Cuff Revision Surgery

Recruiting now · Not applicable

Conditions studied: Rotator Cuff Repair

In brief

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.

Key facts

Study ID

NCT06257979

Run by

Elsan

People needed

132

Starts

2024-02-27

Expected to finish

2028-03-15

Last updated by the study team

2024-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient, male or female, aged 18 or over
• Patient requiring re- intervention for Rotator Ruff Revision Surgery for non-healing of the same tendons after a first intervention (delay <2 years)
• Patient requiring arthroscopy
• Patient having had realized a MRI of the shoulder in the 6 previous months
• Affiliate participant or beneficiary of a social security scheme
• Participant having been informed and not having objected to the use of their data

You may not qualify if…

• Patient with at least one clinical sign of infection (fever, redness)
• Patient with a new distant rupture on a healed cuff (> 3 years)
• Patient with a history of shoulder surgery other than initial Rotator Ruff Surgery
• Patient having received antibiotic treatment in the 2 weeks preceding inclusion
• Participant in another research
• Participant in a period of exclusion from another research still in progress at the time of inclusion
• Protected participant: an adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
• Pregnant, breastfeeding or parturient woman
• Participant hospitalized without consent

Where it is running

• Clinique de l'Orangerie — Strasbourg, France (enrolling)
• Hôpital privé Saint-Martin — Caen, France
• Clinique Louis Pasteur — Essey-lès-Nancy, France
• Santy-Lyon-Ramsay — Lyon, France
• Hôpital privé La Châtaigneraie ELSAN — Beaumont, France
• ICR-Kantys — Nice, France
• Santé Atlantique ELSAN — Saint-Herblain, France
• Clinique d'occitanie ELSAN — Muret, France

Full record on ClinicalTrials.gov

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