Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570252
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Preoperative Microbial Reduction of the Nasal Cavity With Antimicrobial Photodynamic Therapy aPDT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Double Blinded National Single-center Study to Evaluate the SteriwaveTM Antimicrobial Photodynamic Therapy System for Preoperative Nasal Cavity Decolonization in Adult Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
The goal of this clinical trial is to investigate the preoperative microbial reduction of the nasal cavity using Photodynamic Therapy aPDT in adult patients undergoing surgical intervention at the Department for Craniomaxillofacial Surgery University Hospital Zurich Switzerland
The main question the trial aims to answer is
- Does aPDT reduce microbial colonization in the nasal cavity more effectively 5 minutes after treatment compared to the baseline before intervention
Participants will be randomized into two groups
Study Group Nasal cavity photodisinfection using aPDT
Control Group Treatment with 02 chlorhexidine gluconate and non-light activated methylene blue
Researchers will compare the effectiveness of aPDT against the control treatment in reducing microbial colonization of the nasal cavity
Study Procedure
1 Nasal swab for baseline microbial colonization
2 Application of 02 chlorhexidine gluconate and methylene blue
3 Insertion of nasal light illuminator into the patients nostrils
Study Group Activation of the light source
Control Group No activation of the light source
4 Nasal swab taken 5 minutes after the intervention to assess microbial reduction
The main question the trial aims to answer is
- Does aPDT reduce microbial colonization in the nasal cavity more effectively 5 minutes after treatment compared to the baseline before intervention
Participants will be randomized into two groups
Study Group Nasal cavity photodisinfection using aPDT
Control Group Treatment with 02 chlorhexidine gluconate and non-light activated methylene blue
Researchers will compare the effectiveness of aPDT against the control treatment in reducing microbial colonization of the nasal cavity
Study Procedure
1 Nasal swab for baseline microbial colonization
2 Application of 02 chlorhexidine gluconate and methylene blue
3 Insertion of nasal light illuminator into the patients nostrils
Study Group Activation of the light source
Control Group No activation of the light source
4 Nasal swab taken 5 minutes after the intervention to assess microbial reduction
Detailed Description:
None
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