Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06257979
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-01-05
Brief Title:
Unexpected Positive Cultures in Rotator Cuff Revision Surgery
Sponsor:
Elsan
Organization:
Elsan
Study Overview
Official Title:
Unexpected Positive Cultures in Rotator Cuff Revision Surgery Significance and Influence on Outcomes and Tendon Healing
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POCICO
Brief 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
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
Detailed Description:
Rotator cuff injuries are a common pathology with a 30 prevalence in the general population If rotator cuff repair fails patients often experience persistent pain and bacteria can be detected during the revision period in approximately 30 of cases even in the absence of septic symptoms This type of infection referred to as low-level infection occurs in around 5 of cases and is frequently implicated as a contributing factor to poor outcomes of the intervention
Bacteriological samples are routinely collected during revisions especially for prostheses The appropriate course of action in cases where these samples test positive yet there are no signs of infection remains to be clarified Notably administering antibiotics in response to unexpected positive cultures UPC during the revision period for total shoulder prostheses does not appear to significantly impact results or infection rates
In the context of rotator cuff re-interventions the impact of UPC has not been well-documented The management of UPC particularly regarding antibiotic therapy has not been thoroughly studied and is not currently recommended Further research is needed to establish guidelines for managing positive cultures in the absence of infection symptoms during rotator cuff re-interventions
Bacteriological samples are routinely collected during revisions especially for prostheses The appropriate course of action in cases where these samples test positive yet there are no signs of infection remains to be clarified Notably administering antibiotics in response to unexpected positive cultures UPC during the revision period for total shoulder prostheses does not appear to significantly impact results or infection rates
In the context of rotator cuff re-interventions the impact of UPC has not been well-documented The management of UPC particularly regarding antibiotic therapy has not been thoroughly studied and is not currently recommended Further research is needed to establish guidelines for managing positive cultures in the absence of infection symptoms during rotator cuff re-interventions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None