NCT04286087

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2020

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

November 9, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

February 24, 2020

Last Update Submit

December 1, 2023

Conditions

Deep Neck Space Infections

Outcome Measures

Primary Outcomes (1)

  • Number of participants with reinfection

    1-2 weeks post intervention

Secondary Outcomes (1)

  • Number of participants requiring a scar revision surgery

    4-6 months post intervention

Study Arms (2)

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

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

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

Investigational Arm
standard treatmentPROCEDURE

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

Control Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Craig Pearl, BDS

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 24, 2020

First Posted

February 26, 2020

Study Start

November 9, 2020

Primary Completion

May 30, 2021

Study Completion

November 30, 2021

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share