Unexpected Positive Cultures in Rotator Cuff Revision Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Compare the functional recovery of the shoulder at one year after iterative repair of non-healing rotator cuff between patients with unexpected positive cultures and patients with negative results. — at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
  Compare the functional recovery (Yes/No), at one year after iterative repair of non-healing rotator cuff between patients with unexpected positive cultures and patients with negative results using the Constant Score.
• Compare the 2 groups on tendon healing, after iterative repair of non-healing of the rotator cuff — at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
  Compare the 2 groups on tendon healing (Yes/No), after iterative repair of non-healing of the rotator cuff using the Constant Score.
• Compare the 2 groups on the occurrence of post-operative complications, after iterative repair of non-healing of the rotator cuff — up to one year after the re-intervention
  Compare the 2 groups on the occurrence of post-operative complications (Yes/No), after iterative repair of non-healing of the rotator cuff and list them
• Compare the 2 groups on the patient's other functional scores — at Month 1, Month 3, Month 6 and 1 Year after the re-intervention
  Compare the 2 groups on the patient's other functional scores such as SSV and ASES questionnaries
• Describe the pathogenic germs found in the positive cultures — at Month 1 after the re-intervention
  List of pathogenic germs found in the positive samples

Trial sites (8)

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