Oral Care Study of Postoperative Infections | NCT04163029

Studies
Oral Care Study of Postoperative Infections

NCT04163029

Sponsor

University of Liege

Status

Unknown status

Last Update Posted

Jun 16, 2020Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Cancer, Mouth

Interventions

Preoperative oral care

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 22, 2019Actual

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Feb 1, 2022Estimated

First Submitted Date

Nov 11, 2019

First Submission Date that Met QC Criteria

Nov 13, 2019

First Posted Date

Nov 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2020

Last Update Posted Date

Jun 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Reduce the incidence of post-operative infections after ENT surgery and flap reconstruction by performing preoperative oral and dental care

Detailed Description

Reduce the incidence of post-operative infections after ENT surgery and flap reconstruction by performing preoperative oral and dental care

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
preoperative oral care			Procedure: Preoperative oral care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preoperative oral care	Procedure	tooth brushing and mouthwash with chlorhexidine 0,2% five day before surgery	preoperative oral care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of postoperative infections	incidence of postoperative infections	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ENT surgery with free flap reconstruction

Exclusion Criteria:

Allergy to chlorhexidine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients operated on for transmandibulary buccopharyngectomy with recognition, free flap struction

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benjamin Javillier, MD	Contact	003243667655		benjamin.javillier@chuliege.be

Overall Officials

Name	Affiliation	Role
Benjamin Javillier, MD	Centre Hospitalier Universitaire de Liege	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Liege, University Hospital	Recruiting	Liège		4000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D009062	Mouth Neoplasms

Ancestor Terms

ID	Term
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided