Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513598
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Pathogenesis of Postoperative Infections and Biomarkers for Early Diagnosis of it
Sponsor:
None
Organization:
None
Study Overview
Official Title:
New Studies of the Pathogenesis of Postoperative Infections and Development of Biomarkers for Early Diagnosis of Postoperative Complications
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Infections remain a prevalent complication after major abdominal surgery The common belief that most surgical site infections SSIs following elective surgery with modern antiseptic techniques are due to intraoperative contamination is still not confirmed Therefore alternative mechanisms for SSI development such as the Trojan Horse theory-which suggests that pathogens from distant sites like the gastrointestinal tract may cause postoperative infections-should be explored This study aims to analyze the preoperative microbiome of surgical patients gut and oral cavities and assess whether microorganisms found there are present at the infection site Additionally this study will investigate a panel of biomarkers for predicting postoperative infections
Detailed Description:
Infections remain a significant concern following major abdominal surgery The prevailing notion that most surgical site infections SSIs after elective surgery with modern antiseptic techniques are solely caused by intraoperative contamination remains unconfirmed Therefore alternative mechanisms for SSI development such as the Trojan Horse theory-which suggests that pathogens from distant sites like the gastrointestinal tract may contribute to postoperative infections-require thorough investigation This longitudinal observational study aims to either support or challenge the Trojan Horse theory
This study will enroll patients undergoing major abdominal surgery for confirmed or suspected cancer Biological samples from stool the oral cavity and infection sites will be collected for sequencing and microbiome analysis to evaluate the presence of pathogens potentially responsible for postoperative infections originating from the gastrointestinal tract Additionally blood samples will be collected to identify predictive biomarkers associated with the development of postoperative infections
This study will enroll patients undergoing major abdominal surgery for confirmed or suspected cancer Biological samples from stool the oral cavity and infection sites will be collected for sequencing and microbiome analysis to evaluate the presence of pathogens potentially responsible for postoperative infections originating from the gastrointestinal tract Additionally blood samples will be collected to identify predictive biomarkers associated with the development of postoperative infections
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None