Unexpected Positive Cultures in Rotator Cuff Revision Surgery
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
| Condition(s) | Rotator Cuff Repair |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * 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 Exclusion Criteria: * 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Elsan |
| Locations | Beaumont, France; Caen, France; Essey-lès-Nancy, France; Lyon, France; Muret, France; Nice, France (+2 more sites) |
| Start date | 2024-02-27 |
| NCT ID | NCT06257979 |
| Official listing | https://clinicaltrials.gov/study/NCT06257979 |