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Unexpected Positive Cultures in Rotator Cuff Revision Surgery

NCT06257979 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2024-06-18

No results posted yet for this 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.

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.

Sponsors & Collaborators

  • Elsan

    lead OTHER

Principal Investigators

  • Maxime ANTONI, MD · Clinique de l'Orangerie-Strasbourg

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-27
Primary Completion
2028-02-15
Completion
2028-03-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06257979 on ClinicalTrials.gov