Actively Recruiting
Study of Unexpected Positive Cultures in Rotator Cuff Revision Surgery and Their Effect on Healing and Outcomes
Led by Elsan · Updated on 2024-06-18
132
Participants Needed
8
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Rotator cuff injuries affect about 30% of the general population, and when repair fails, patients often suffer persistent pain. During revision surgeries, bacteria can be found in about 30% of cases without clear infection signs, known as low-level infections, which may contribute to poor outcomes. This study investigates the impact of unexpected positive cultures UPC found during rotator cuff re-intervention and aims to determine how these cultures influence clinical outcomes and tendon healing. The research compares two groups of patients undergoing rotator cuff revision those with positive microbiological samples and those with negative samples taken during surgery. The study involves collecting and analyzing bacteriological samples from operative elements like sutures and tendon tissue during the re-intervention. Antibiotics are not given immediately after surgery or during the first month unless a pathogenic microorganism is identified, in which case antibiotic treatment starts and the participant discontinues the study. Participants will be followed at 1 month, 3 months, 6 months, and 1 year after surgery. Assessments include shoulder functional recovery, tendon healing using MRI-based Sugaya scores, occurrence of post-operative complications, and identification of pathogenic bacteria. Questionnaires and clinical evaluations will track outcomes, with safety and healing monitored over the year to understand the influence of positive cultures on recovery.
CONDITIONS
Brief Title
Unexpected Positive Cultures in Rotator Cuff Revision Surgery
Research Team
A
Albatoul ZAKARIA, PhD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here