Deep Neck Space InfectionsNCT04286087
Assessment of Clinical Outcomes in Closure of Deep Neck Space Infection Incisions
A study testing neck incisions closed at bedside at the time of drain removal under local anesthesia and standard treatment in people with Deep Neck Space Infections, run by The University of Texas Health Science Center, Houston.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Deep Neck Space Infections
- What is being tested?
- neck incisions closed at bedside at the time of drain removal under local anesthesia and standard treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Nov 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- deep neck space infection
- who require a conservative unilateral submandibular neck incision to access affected deep fascial neck spaces
Who cannot join
- pregnant females
- cognitively impaired individuals
- deep neck space infections which require bilateral neck incisions, large neck apron incisions, or placement of negative pressure therapy.
About this study
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.
- Conditions
- Deep Neck Space Infections
- Being tested
- neck incisions closed at bedside at the time of drain removal under local anesthesia, standard treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neck incisions closed at bedside at the time of drain removal under local anesthesiaProcedure or surgery
Participants allocated to the investigational group will have neck incisions closed at bedside at the time of drain removal under local anesthesia
standard treatmentProcedure or surgery
Participants in the control group will have standard treatment performed as per current practice,their incision will be left to close by secondary intention
| Study group | Role | What they receive |
|---|---|---|
| Investigational Arm | Experimental | Not described Receives: Procedure: neck incisions closed at bedside at the time of drain removal under local anesthesia |
| Control Group | Active comparator | Not described Receives: Procedure: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with reinfection
Measured: 1-2 weeks post intervention
Secondary outcomes (1)
Number of participants requiring a scar revision surgery
Measured: 4-6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start9 Nov 2020 (estimated)
- Primary completion30 May 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
Why it stopped: Dr Rudecki, the principal PI has left the program and is no longer in the United States therefore he failed to recruit patients for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Neck Space InfectionsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Bradley Pearl, The University of Texas Health Science Center, Houston
- Investigators
- Craig Pearl, BDS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286087
- Sponsor's protocol ID
- HSC-DB-19-1029
- Status last verified
- Dec 2023
- First submitted
- 24 Feb 2020
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Clinical Outcomes in Closure of Deep Neck Space Infection Incisions
- ClinicalTrials.gov ID
- NCT04286087
- Acronym / sponsor ID
- HSC-DB-19-1029
- Conditions
- Deep Neck Space Infections
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Dr Rudecki, the principal PI has left the program and is no longer in the United States therefore he failed to recruit patients for the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 9 Nov 2020 (estimated)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- deep neck space infection
- who require a conservative unilateral submandibular neck incision to access affected deep fascial neck spaces
Key exclusion criteria (3 listed)
- pregnant females
- cognitively impaired individuals
- deep neck space infections which require bilateral neck incisions, large neck apron incisions, or placement of negative pressure therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neck incisions closed at bedside at the time of drain removal under local anesthesiaParticipants allocated to the investigational group will have neck incisions closed at bedside at the time of drain removal under local anesthesia | Procedure or surgery | Investigational Arm |
| standard treatmentParticipants in the control group will have standard treatment performed as per current practice,their incision will be left to close by secondary intention | Procedure or surgery | Control Group |
Primary outcome
Number of participants with reinfection
Time frame: 1-2 weeks post intervention
1 secondary outcome
Number of participants requiring a scar revision surgery
Time frame: 4-6 months post intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Pearl, BDS principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A study testing neck incisions closed at bedside at the time of drain removal under local anesthesia and standard treatment in people with Deep Neck Space Infections, run by The University of Texas Health Science Center, Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with reinfection (time frame: 1-2 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.