Surgical Site InfectionPhase 4NCT03483363
Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds
A Phase 4 study testing topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline), topical irrigation with sterile normal saline (NS) and intravenous (IV) prophylactic antibiotic in people with Surgical Site Infection, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of topical antibiotic irrigation (gentamycin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline), topical irrigation with sterile normal saline (NS) and intravenous (IV) prophylactic antibiotic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2018to 2 Jan 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- patients who are planned for open reduction internal fixation of midfacial fractures as part of standard of care
- patients who are admitted to Memorial Hermann hospital at Texas Medical Center
- able to sign their own consent
Who cannot join
- infected surgical sites
- allergies to bacitracin
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to evaluate the use of topical antibiotic irrigation (gentamycin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS).
Previously, this study evaluated a different antibiotic, bacitracin, but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.
- Conditions
- Surgical Site Infection
- Being tested
- topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline), topical irrigation with sterile normal saline (NS), intravenous (IV) prophylactic antibiotic
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline)Drug
Fractures will be irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure.
topical irrigation with sterile normal saline (NS)Drug
Fractures will be irrigated with sterile normal saline prior to closure.
intravenous (IV) prophylactic antibioticDrug
All arms with receive standard parenteral (IV) prophylactic antibiotic.
| Study group | Role | What they receive |
|---|---|---|
| topical irrigation with the antibiotic plus intravenous (IV) prophylactic antibiotic | Experimental | Fractures will be topically irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure.
[previously, this arm involve topical irrigation with bacitracin topical antibiotic (50,000 units), but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.] Receives: Drug: topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline); Drug: intravenous (IV) prophylactic antibiotic |
| topical irrigation with sterile normal saline (NS) plus intravenous (IV) prophylactic antibiotic | Active comparator | Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic. Receives: Drug: topical irrigation with sterile normal saline (NS); Drug: intravenous (IV) prophylactic antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Surgical Site Infection (SSI)
Surgical site infections include evidence of infection: persistent swelling, fever, recurrent swelling, erythema, and purulent discharge.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start9 Oct 2018
- Primary completion2 Jan 2022
- Study completion2 Jan 2022
Why it stopped: recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Site InfectionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 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, MDDS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483363
- Sponsor's protocol ID
- HSC-DB-18-0038
- Status last verified
- Apr 2024
- First submitted
- 23 Mar 2018
- Last updated
- 8 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds
- ClinicalTrials.gov ID
- NCT03483363
- Acronym / sponsor ID
- HSC-DB-18-0038
- Conditions
- Surgical Site Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment issues
- Enrolment
- 39 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 2 Jan 2022 (actual)
- Study completion
- 2 Jan 2022 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Posted 8 May 2024
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 evaluate the use of topical antibiotic irrigation (gentamycin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS).
Previously, this study evaluated a different antibiotic, bacitracin, but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| topical irrigation with the antibiotic plus intravenous (IV) prophylactic antibiotic | Experimental | Drug: topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline), Drug: intravenous (IV) prophylactic antibioticFractures will be topically irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure. [previously, this arm involve topical irrigation with bacitracin topical antibiotic (50,000 units), but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.] |
| topical irrigation with sterile normal saline (NS) plus intravenous (IV) prophylactic antibiotic | Active comparator | Drug: topical irrigation with sterile normal saline (NS), Drug: intravenous (IV) prophylactic antibioticFractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who are planned for open reduction internal fixation of midfacial fractures as part of standard of care
- patients who are admitted to Memorial Hermann hospital at Texas Medical Center
- able to sign their own consent
Key exclusion criteria (2 listed)
- infected surgical sites
- allergies to bacitracin
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 |
|---|---|---|
| topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline)Fractures will be irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure. | Drug | topical irrigation with the antibiotic plus intravenous (IV) prophylactic antibiotic |
| topical irrigation with sterile normal saline (NS)Fractures will be irrigated with sterile normal saline prior to closure. | Drug | topical irrigation with sterile normal saline (NS) plus intravenous (IV) prophylactic antibiotic |
| intravenous (IV) prophylactic antibioticAll arms with receive standard parenteral (IV) prophylactic antibiotic. | Drug | topical irrigation with sterile normal saline (NS) plus intravenous (IV) prophylactic antibiotic, topical irrigation with the antibiotic plus intravenous (IV) prophylactic antibiotic |
Primary outcome
Number of Participants With Surgical Site Infection (SSI)
Time frame: 8 weeks
Surgical site infections include evidence of infection: persistent swelling, fever, recurrent swelling, erythema, and purulent discharge.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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, MDDS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline), topical irrigation with sterile normal saline (NS) and intravenous (IV) prophylactic antibiotic in people with Surgical Site Infection, run by The University of Texas Health Science Center, Houston at 1 site 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 3 inclusion and 2 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Surgical Site Infection (SSI) (time frame: 8 weeks). 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 May 2024.