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

Deep Neck Space Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04286087
• Other study ID #: HSC-DB-19-1029
• Status: Withdrawn
• Phase: N/A
• Start date: November 9, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Deep Neck Space Infections
• Infections

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with reinfection		1-2 weeks post intervention
Secondary	Number of participants requiring a scar revision surgery		4-6 months post intervention