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

Primary Purpose

Deep Neck Space Infections

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

standard treatment

About this trial

This is an interventional treatment trial for Deep Neck Space Infections

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Investigational Arm

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with reinfection

Secondary Outcome Measures

Number of participants requiring a scar revision surgery

Full Information

NCT ID

NCT04286087

First Posted

February 24, 2020

Last Updated

February 25, 2020

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT04286087

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2020 (Anticipated)

Primary Completion Date

September 30, 2020 (Anticipated)

Study Completion Date

September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deep Neck Space Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Investigational Arm

Arm Type

Experimental

Arm Title

Control Group

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

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

Intervention Description

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

Intervention Name(s)

standard treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with reinfection

Time Frame

1-2 weeks post intervention

Secondary Outcome Measure Information:

Title

Number of participants requiring a scar revision surgery

Time Frame

4-6 months post intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Craig Pearl, BDS

Phone

(713) 500-7831

Craig.B.Pearl@uth.tmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Dominik Rudecki

Phone

832-474-9248

Dominik.A.Rudecki@uth.tmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Craig Pearl, BDS

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Craig Pearl, BDS

Phone

713-500-7831

Craig.B.Pearl@uth.tmc.edu

First Name & Middle Initial & Last Name & Degree

Dominik Rudecki

Phone

832-474-9248

Dominik.A.Rudecki@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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