Unexpected Positive Cultures in Rotator Cuff Revision Surgery
Unexpected Positive Cultures in Rotator Cuff Revision Surgery: Significance and Influence on Outcomes and Tendon Healing
Elsan
132 participants
Feb 27, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria9
- 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
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Interventions
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)
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NCT06257979