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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04286087
Enrollment
0
Registered
2020-02-26
Start date
2020-11-09
Completion date
2021-11-30
Last updated
2023-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Neck Space Infections

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.

Interventions

PROCEDUREneck 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

PROCEDUREstandard 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

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Number of participants with reinfection1-2 weeks post intervention

Secondary

MeasureTime frame
Number of participants requiring a scar revision surgery4-6 months post intervention

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026