Prosthetic Valve Sweing Ring Injection by Antiboitics Can Affect the Rate of Postoperative Infective Endocarditis?

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05455788
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 24.4
• Patients Per Site Per Month: 12.3

Study Details

Study Description

Brief Summary

Follow-up of patients undergoing cardiac valve replacements with prosthetic valve after injection of sewing ring of prosthetic valve with aminoglycoside for prevention of infective endocarditis.

Condition or Disease	Intervention/Treatment	Phase
Prosthetic Valve Endocarditis	Drug: Aminoglycoside

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prosthetic Valve Sweing Ring Injection by Antiboitics Can Affect the Rate of Postoperative Infective Endocarditis?
• Actual Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients undergoing Cardiac valve replacement	Drug: Aminoglycoside; injection of sewing ring of prosthetic valve with aminoglycoside

Outcome Measures

Primary Outcome Measures

1. number of patients diagnosed with Infective endocarditis post valve replacement [6 months post operative]

   percentage of post operative clinical and echocardiographic diagnosis of infective endocarditis on prosthetic valve

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• patients who need cardiac valve replacement for rheumatic or degenerative causes

Exclusion Criteria:

• Patients undergoing open heart surgery for any cause other than valve replacement

• patients who are younger than 20 years old.

• Patients undergoing valve repair.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University	Assiut		Egypt	21557

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amr Ibrahim Osman, Principle investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT05455788
• Other Study ID Numbers: AssiutMedic
• First Posted: Jul 13, 2022
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Endocarditis, Bacterial; Endocarditis

Study Results

No Results Posted as of Jul 13, 2022