Assessment of Clinical Outcomes in Closure of Deep Neck S... | NCT04286087

Studies
Assessment of Clinical Outcomes in Closure of Deep Neck Space Infection Incisions

NCT04286087

Sponsor

The University of Texas Health Science Center, Houston

Status

Withdrawn

Last Update Posted

Dec 8, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Deep Neck Space Infections

Interventions

neck incisions closed at bedside at the time of drain removal under local anesthesia
standard treatment

Countries

Not provided

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Dr Rudecki, the principal PI has left the program and is no longer in the United States therefore he failed to recruit patients for the study.

Expanded Access Info

Start Date

Nov 9, 2020Estimated

Primary Completion Date

May 30, 2021Estimated

Completion Date

Nov 30, 2021Estimated

First Submitted Date

Feb 24, 2020

First Submission Date that Met QC Criteria

Feb 25, 2020

First Posted Date

Feb 26, 2020Actual

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

Dec 1, 2023

Last Update Posted Date

Dec 8, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Craig Bradley Pearl, Assistant Professor, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Not provided

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

The purpose of this study is to determine if closure of deep neck infection incisions at the time of extraoral drain removal has any impact on rates of reinfection and to determine if this treatment will have any impact on scar formation and qualitative measures of pain or impact on quality of life during the post-operative healing period.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Investigational Arm	Experimental		Procedure: neck incisions closed at bedside at the time of drain removal under local anesthesia
Control Group	Active Comparator		Procedure: standard treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
neck incisions closed at bedside at the time of drain removal under local anesthesia	Procedure	Participants allocated to the investigational group will have neck incisions closed at bedside at the time of drain removal under local anesthesia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with reinfection		1-2 weeks post intervention

Secondary Outcomes

Measure	Description	Time Frame
Number of participants requiring a scar revision surgery		4-6 months post intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

deep neck space infection
who require a conservative unilateral submandibular neck incision to access affected deep fascial neck spaces

Exclusion Criteria:

pregnant females
cognitively impaired individuals
deep neck space infections which require bilateral neck incisions, large neck apron incisions, or placement of negative pressure therapy.

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Craig Pearl, BDS	The University of Texas Health Science Center, Houston	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided