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

NCT ID: NCT04286087

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-09

Study Completion Date

2021-11-30

Brief Summary

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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

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Conditions

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Deep Neck Space Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Investigational Arm

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

Participants allocated to the investigational group will have neck incisions closed at bedside at the time of drain removal under local anesthesia

Control Group

Group Type ACTIVE_COMPARATOR

standard treatment

Intervention Type PROCEDURE

Participants in the control group will have standard treatment performed as per current practice,their incision will be left to close by secondary intention

Interventions

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

Participants allocated to the investigational group will have neck incisions closed at bedside at the time of drain removal under local anesthesia

Intervention Type PROCEDURE

standard treatment

Participants in the control group will have standard treatment performed as per current practice,their incision will be left to close by secondary intention

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Craig Bradley Pearl

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Craig Pearl, BDS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Countries

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United States

Other Identifiers

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HSC-DB-19-1029

Identifier Type: -

Identifier Source: org_study_id