Jaw FracturesPhase 1NCT04198129
The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures
A Phase 1 study testing Antibiotic treatment (Unasyn or Cleocin) and Antibiotic treatment (Augmentin or Cleocin) in people with Jaw Fractures and Infection, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial summary
The purpose of the study is to evaluate if postoperative antibiotic use in patients with mandible trauma reduce the risk of postoperative infections and does the benefit differ based on severity, soft tissue loss, other concomitant injuries, and medical problems Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jaw Fractures, Infection
- What is being tested?
- Antibiotic treatment (Unasyn or Cleocin) and Antibiotic treatment (Augmentin or Cleocin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2020to 20 Mar 2022
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All mandible fracture patients planned for Open Reduction and Internal Fixation (ORIF)
Who cannot join
- Age - < 18 years
- Pregnancy
- Fracture Site - closed / non-dentate eg. Condylar neck, edentulous
- Soft Tissue Injury - > Grade 4 (GSW)
- Allergic to all study drugs
- Medical Problems
Show all 14Show fewer
- Diabetes - Hb A1C > 10
- Immunologic compromise
- On Chemotherapy
- Interval - Injury to Surgery - > 10days
- Already receiving antibiotics for
- Another wound eg. Open fracture prophylaxis
- Documented / suspected infection
- Inability to provide informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Hermann Hospital
Houston, Texas, 77030
Th University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of the study is to evaluate if postoperative antibiotic use in patients with mandible trauma reduce the risk of postoperative infections and does the benefit differ based on severity, soft tissue loss, other concomitant injuries, and medical problems
Read the detailed description
The purpose of this study is to evaluate the use of antibiotics postoperatively in non-infected mandible fractures compared to the lack of postoperative antibiotics in the same population.
The first outcome measure is infection. Evidence of infection includes persistent swelling, fever, recurrent swelling, erythema, and purulent discharge.
The second outcome measure is no infection. Absence of persistent swelling, fever, recurrent swelling, erythema, and purulent discharge.
Outcome measures will be assessed on follow-up visits: post op week 1, post op week 3, and post op week 6-8. Latest follow-up is up to 8 weeks. If the subject presents with any of the above mentioned symptoms during the 8 week post-op period, the subject will be considered positive for infection.
Prospective randomized trial: Control group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care. Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies), then the patients in the trial group will be switched to oral Augmentin 875mg twice a day for 7 days (Amoxicillin and Clavulanic acid which is clinically interchangeable with Unasyn), or oral Clindamycin 150mg to 300mg four times a day for 7 days (for penicillin allergies). If the patient is discharged home prior to completing 7 days of oral antibiotic therapy, patient will receive prescription to finish the remaining doses of antibiotics for a total period of 7 days.
The patient will follow up post op week 1, post op week 3, and post op week 6-8. Latest follow-up is up to 8 weeks.
Patients will be monitored for any complications, including reaction to IV and oral antibiotics. Patient will assessed after the one-time post-op IV antibiotic dose and during their follow-up visits at weeks 1, 3, and 6-8.
- Conditions
- Jaw Fractures, Infection
- Being tested
- Antibiotic treatment (Unasyn or Cleocin), Antibiotic treatment (Augmentin or Cleocin), Control Group
- Keywords
- Infection, Jaw fracture
- Medical subject headings
- Jaw Fractures, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic treatment (Unasyn or Cleocin)Drug
Also called UNasyn is the trade name and the genric name is Ampicillin and Sub lactam. Cleocin is a trade name and the generic name is clindamycin.
Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies)
Antibiotic treatment (Augmentin or Cleocin)Drug
Also called Augmentin is the trade name and the generic is Amoxicillin Clavulinate or clavulinic acid. Cleocin is the trade name and the generic is clindamycin.
the patients in the trial group will be switched to oral Augmentin 875mg twice a day for 7 days, or oral Clindamycin 150mg to 300mg four times a day for 7 days (for penicillin allergies).
Control GroupOther
Control group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies), then the patients in the trial group will be switched to oral Augmentin 875mg twice a day for 7 days (Amoxicillin and Clavulanic acid which is clinically interchangeable with Unasyn), or oral Clindamycin 150mg to 300mg four times a day for 7 days (for penicillin allergies). If the patient is discharged home prior to completing 7 days of oral antibiotic therapy, patient will receive prescription to finish the remaining doses of antibiotics for a total period of 7 days. Receives: Drug: Antibiotic treatment (Unasyn or Cleocin); Drug: Antibiotic treatment (Augmentin or Cleocin) |
| Control | Active comparator | Control group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of infection as measured by presence of persistent swelling,
Measured: post treatment week1
Evidence of infection as measured by presence of persistent swelling,
Measured: post treatment week 3
Evidence of infection as measured by presence of persistent swelling,
Measured: post treatment week 6-8
Evidence of infection as measured by presence of fever
Measured: post treatment week 1
Evidence of infection as measured by presence of fever
Measured: post treatment week 3
Evidence of infection as measured by presence of fever
Measured: post treatment week 6-8
Evidence of infection as measured by presence of recurrent swelling
Measured: post treatment week 1
Evidence of infection as measured by presence of recurrent swelling
Measured: post treatment week 3
Evidence of infection as measured by presence of recurrent swelling
Measured: post treatment week 6-8
Evidence of infection as measured by presence of erythema
Measured: post treatment week 1
Evidence of infection as measured by presence of erythema
Measured: post treatment week 3
Evidence of infection as measured by presence of erythema
Measured: post treatment week 6-8
Evidence of infection as measured by presence of purulent discharge
Measured: post treatment week 1
Evidence of infection as measured by presence of purulent discharge
Measured: post treatment week 3
Evidence of infection as measured by presence of purulent discharge
Measured: post treatment week 6-8
Secondary outcomes (15)
No evidence of infection as measured by absence of persistent swelling
Measured: post treatment week 1
No evidence of infection as measured by absence of persistent swelling
Measured: post treatment week 3
No evidence of infection as measured by absence of persistent swelling
Measured: post treatment week 6-8
No evidence of infection as measured by absence of fever
Measured: post treatment week 1
No evidence of infection as measured by absence of fever
Measured: post treatment week 3
No evidence of infection as measured by absence of fever
Measured: post treatment week 6-8
No evidence of infection as measured by absence of recurrent swelling
Measured: post treatment week 1
No evidence of infection as measured by absence of recurrent swelling
Measured: post treatment week 3
No evidence of infection as measured by absence of recurrent swelling
Measured: post treatment week 6-8
No evidence of infection as measured by absence of erythema
Measured: post treatment week 1
No evidence of infection as measured by absence of erythema
Measured: post treatment week 3
No evidence of infection as measured by absence of erythema
Measured: post treatment week 6-8
No evidence of infection as measured by absence of purulent discharge
Measured: post treatment week 1
No evidence of infection as measured by absence of purulent discharge
Measured: post treatment week 3
No evidence of infection as measured by absence of purulent discharge
Measured: post treatment week 6-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Oct 2020
- Primary completion20 Jan 2022
- Study completion20 Mar 2022
Why it stopped: Recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw FracturesStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagi Demian, The University of Texas Health Science Center, Houston
- Investigators
- Nagi Demian, DDS/MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198129
- Sponsor's protocol ID
- HSC-MS-18-0640
- Status last verified
- Feb 2024
- First submitted
- 9 Dec 2019
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures
- ClinicalTrials.gov ID
- NCT04198129
- Acronym / sponsor ID
- HSC-MS-18-0640
- Conditions
- Jaw Fractures, Infection
- Keywords
- Infection, Jaw fracture
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issues
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 13 Dec 2019 (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 the study is to evaluate if postoperative antibiotic use in patients with mandible trauma reduce the risk of postoperative infections and does the benefit differ based on severity, soft tissue loss, other concomitant injuries, and medical problems
Detailed description
The purpose of this study is to evaluate the use of antibiotics postoperatively in non-infected mandible fractures compared to the lack of postoperative antibiotics in the same population.
The first outcome measure is infection. Evidence of infection includes persistent swelling, fever, recurrent swelling, erythema, and purulent discharge.
The second outcome measure is no infection. Absence of persistent swelling, fever, recurrent swelling, erythema, and purulent discharge.
Outcome measures will be assessed on follow-up visits: post op week 1, post op week 3, and post op week 6-8. Latest follow-up is up to 8 weeks. If the subject presents with any of the above mentioned symptoms during the 8 week post-op period, the subject will be considered positive for infection.
Prospective randomized trial: Control group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care. Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies), then the patients in the trial group will be switched to oral Augmentin 875mg twice a day for 7 days (Amoxicillin and Clavulanic acid which is clinically interchangeable with Unasyn), or oral Clindamycin 150mg to 300mg four times a day for 7 days (for penicillin allergies). If the patient is discharged home prior to completing 7 days of oral antibiotic therapy, patient will receive prescription to finish the remaining doses of antibiotics for a total period of 7 days.
The patient will follow up post op week 1, post op week 3, and post op week 6-8. Latest follow-up is up to 8 weeks.
Patients will be monitored for any complications, including reaction to IV and oral antibiotics. Patient will assessed after the one-time post-op IV antibiotic dose and during their follow-up visits at weeks 1, 3, and 6-8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Antibiotic treatment (Unasyn or Cleocin), Drug: Antibiotic treatment (Augmentin or Cleocin)Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies), then the patients in the trial group will be switched to oral Augmentin 875mg twice a day for 7 days (Amoxicillin and Clavulanic acid which is clinically interchangeable with Unasyn), or oral Clindamycin 150mg to 300mg four times a day for 7 days (for penicillin allergies). If the patient is discharged home prior to completing 7 days of oral antibiotic therapy, patient will receive prescription to finish the remaining doses of antibiotics for a total period of 7 days. |
| Control | Active comparator | Other: Control GroupControl group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All mandible fracture patients planned for Open Reduction and Internal Fixation (ORIF)
Key exclusion criteria (14 listed)
- Age - < 18 years
- Pregnancy
- Fracture Site - closed / non-dentate eg. Condylar neck, edentulous
- Soft Tissue Injury - > Grade 4 (GSW)
- Allergic to all study drugs
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 |
|---|---|---|
| Antibiotic treatment (Unasyn or Cleocin)Also: UNasyn is the trade name and the genric name is Ampicillin and Sub lactam. Cleocin is a trade name and the generic name is clindamycin.Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies) | Drug | Treatment |
| Antibiotic treatment (Augmentin or Cleocin)Also: Augmentin is the trade name and the generic is Amoxicillin Clavulinate or clavulinic acid. Cleocin is the trade name and the generic is clindamycin.the patients in the trial group will be switched to oral Augmentin 875mg twice a day for 7 days, or oral Clindamycin 150mg to 300mg four times a day for 7 days (for penicillin allergies). | Drug | Treatment |
| Control GroupControl group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care | Other | Control |
Primary outcome
Evidence of infection as measured by presence of persistent swelling,
Time frame: post treatment week1
Evidence of infection as measured by presence of persistent swelling,
Time frame: post treatment week 3
Evidence of infection as measured by presence of persistent swelling,
Time frame: post treatment week 6-8
Evidence of infection as measured by presence of fever
Time frame: post treatment week 1
Evidence of infection as measured by presence of fever
Time frame: post treatment week 3
Evidence of infection as measured by presence of fever
Time frame: post treatment week 6-8
Evidence of infection as measured by presence of recurrent swelling
Time frame: post treatment week 1
Evidence of infection as measured by presence of recurrent swelling
Time frame: post treatment week 3
Evidence of infection as measured by presence of recurrent swelling
Time frame: post treatment week 6-8
Evidence of infection as measured by presence of erythema
Time frame: post treatment week 1
Evidence of infection as measured by presence of erythema
Time frame: post treatment week 3
Evidence of infection as measured by presence of erythema
Time frame: post treatment week 6-8
Evidence of infection as measured by presence of purulent discharge
Time frame: post treatment week 1
Evidence of infection as measured by presence of purulent discharge
Time frame: post treatment week 3
Evidence of infection as measured by presence of purulent discharge
Time frame: post treatment week 6-8
15 secondary outcomes
No evidence of infection as measured by absence of persistent swelling
Time frame: post treatment week 1
No evidence of infection as measured by absence of persistent swelling
Time frame: post treatment week 3
No evidence of infection as measured by absence of persistent swelling
Time frame: post treatment week 6-8
No evidence of infection as measured by absence of fever
Time frame: post treatment week 1
No evidence of infection as measured by absence of fever
Time frame: post treatment week 3
No evidence of infection as measured by absence of fever
Time frame: post treatment week 6-8
No evidence of infection as measured by absence of recurrent swelling
Time frame: post treatment week 1
No evidence of infection as measured by absence of recurrent swelling
Time frame: post treatment week 3
No evidence of infection as measured by absence of recurrent swelling
Time frame: post treatment week 6-8
No evidence of infection as measured by absence of erythema
Time frame: post treatment week 1
No evidence of infection as measured by absence of erythema
Time frame: post treatment week 3
No evidence of infection as measured by absence of erythema
Time frame: post treatment week 6-8
No evidence of infection as measured by absence of purulent discharge
Time frame: post treatment week 1
No evidence of infection as measured by absence of purulent discharge
Time frame: post treatment week 3
No evidence of infection as measured by absence of purulent discharge
Time frame: post treatment week 6-8
Results and safety
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Nagi Demian, DDS/MD principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Antibiotic treatment (Unasyn or Cleocin) and Antibiotic treatment (Augmentin or Cleocin) in people with Jaw Fractures and Infection, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
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 1 inclusion and 14 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: stopped early, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment issues). Results are not available in the source record.
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?
Evidence of infection as measured by presence of persistent swelling, (time frame: post treatment week1). The study lists 15 primary outcomes in all. 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 26 Jun 2025.