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

December 1, 2023 updated by: Craig Bradley Pearl, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
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
Experimental: Investigational Arm
Procedure: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Craig Pearl, BDS, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 9, 2020

Primary Completion (Estimated)

May 30, 2021

Study Completion (Estimated)

November 30, 2021

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-DB-19-1029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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