Examining the impact of unexpected positive cultures in rotator cuff revision surgery
Unexpected Positive Cultures in Rotator Cuff Revision Surgery: Significance and Influence on Outcomes and Tendon Healing
This study is testing how unexpected bacteria found during rotator cuff surgery, even when there are no signs of infection, might affect recovery and healing for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elsan Academic / other |
| Locations | 8 sites (Beaumont and 7 other locations) |
| Trial ID | NCT06257979 on ClinicalTrials.gov |
What this trial studies
This interventional study investigates the effects of unexpected positive cultures (UPC) found during rotator cuff revision surgeries. It aims to determine whether the presence of these cultures, in the absence of clinical infection symptoms, affects clinical outcomes and tendon healing rates. The study will involve collecting bacteriological samples from patients undergoing re-intervention for rotator cuff repairs and comparing results from those with positive and negative cultures. The findings could help clarify the management of UPC and inform antibiotic therapy guidelines.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over requiring re-intervention for rotator cuff repair within two years of their initial surgery, without signs of infection.
Not a fit: Patients exhibiting clinical signs of infection or those with a history of other shoulder surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients undergoing rotator cuff revision surgery, potentially enhancing recovery outcomes.
How similar studies have performed: While the management of UPC in rotator cuff surgeries has not been extensively studied, similar approaches in other surgical contexts have shown mixed results, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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 this trial is running
Beaumont and 7 other locations
- Hôpital privé La Châtaigneraie ELSAN — Beaumont, France (Not_yet_recruiting)
- Hôpital privé Saint-Martin — Caen, France (Not_yet_recruiting)
- Clinique Louis Pasteur — Essey-lès-Nancy, France (Not_yet_recruiting)
- Santy-Lyon-Ramsay — Lyon, France (Not_yet_recruiting)
- Clinique d'occitanie ELSAN — Muret, France (Not_yet_recruiting)
- ICR-Kantys — Nice, France (Not_yet_recruiting)
- Santé Atlantique ELSAN — Saint-Herblain, France (Not_yet_recruiting)
- Clinique de l'Orangerie — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Albatoul ZAKARIA, PhD
- Email: zakaria@elsan.care
- Phone: 0033 6 49 77 17 52
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.