Gustilo-Anderson Type III Open Tibia FracturePhase 4NCT05402995
Randomized Trial Comparing Irrisept to Saline Irrigation for Infection Prevention
A Phase 4 study testing Irrisept (Irrigation Solution) and Saline in people with Gustilo-Anderson Type III Open Tibia Fracture, run by Brett D. Crist at 1 site in United States.
Trial summary
Early debridement and definitive fixation, at the initial operative setting, historically led to no difference in the infection rates for Gustilo-Anderson type III open tibia fractures. However, Lenarz et al. reported that delaying definitive fixation in open tibia fractures could decrease the deep infection rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gustilo-Anderson Type III Open Tibia Fracture
- What is being tested?
- Irrisept (Irrigation Solution) and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2022to 31 Aug 2023
- 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
- Adult, 18 or over
- Gustilo-Anderson type III open tibia fracture
- Able to obtain informed consent from patient
Who cannot join
- Minor, under 18
- Pregnancy
- Prisoner
- Allergic to chlorhexidine gluconate
- Allergic to vancomycin or tobramycin
- Patient's tibia is unable to accommodate the smallest antibiotic nail
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Health System
Columbia, Missouri, 65212
About this study
Official title: Prospective Randomized Control Trial Comparing Irrisept to Saline Irrigation for the Prevention of Infection After Open Tibia Fractures
Early debridement and definitive fixation, at the initial operative setting, historically led to no difference in the infection rates for Gustilo-Anderson type III open tibia fractures. However, Lenarz et al. reported that delaying definitive fixation in open tibia fractures could decrease the deep infection rate. At the University of Missouri, the investigators found that staged procedures, including initial debridement-temporary fixation and delayed definitive fixation, did not statistically decrease the rate of deep infection in Gustilo-Anderson type III fractures, prompting the study that is being proposed here. Antibiotic cement coated intramedullary nails have been used in management of infected long bone fractures. Since external fixation and staged debridement did not decrease type III open tibia infection rate, the investigators wanted to consider using antibiotic cement coated nails to deliver antibiotics locally in the acute open fracture setting to prophylactically decrease associated infection rate. Additionally, Irrisept is a wound irrigant that has been used to lower infection rates in different wound settings. To the investigators' knowledge, there are no robust data showing its effectiveness at lowering infection rates in open tibia fracture management. The purpose of this study is to determine the effects of Irrisept and antibiotic nails on lowering deep infection rates in type III open tibia fractures.
- Being tested
- Irrisept (Irrigation Solution), Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrisept (Irrigation Solution)Drug
Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
SalineDrug
Saline irrigation
| Study group | Role | What they receive |
|---|---|---|
| Standard operative debridement and spanning external fixator (reference/control group) | Active comparator | This is the standard of care management. Patient will go to the operating room (OR) first for irrigation and debridement with normal saline and external fixation. Will return to OR at a later date for definitive fixation. Receives: Drug: Saline |
| Spanning external fixator with Irrisept irrigation (treatment group 1) | Experimental | Patient will go to the operating room (OR) first for irrigation and debridement with Irrisept (the experimental irrigation solution) and external fixation. Will return to OR at a later date for definitive fixation. Receives: Drug: Irrisept (Irrigation Solution) |
| Antibiotic-coated medullary nail with saline irrigation (treatment group 2) | Experimental | Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline. Receives: Drug: Saline |
| Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3) | Experimental | Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with Irrisept (the experimental irrigation solution). Receives: Drug: Irrisept (Irrigation Solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Surgical Site Infection (SSI)
Measured by the number of surgical site infections in the total population of patients.
Measured: 90 days
Secondary outcomes (1)
Number of Participants With Fracture Healing
Presence or absence of fracture callous measured on x-ray by an experienced orthopaedic surgeon.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start21 Jun 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Why it stopped: Enrollment was not progressing as expected.
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 Gustilo-Anderson Type III Open Tibia FractureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be enrolled and randomized into one of four groups: 1. Standard operative debridement and spanning external fixator (reference/control group) 2. Spanning external fixator with Irrisept irrigation (treatment group 1) 3. Antibiotic-coated medullary nail with saline irrigation (treatment group 2) or 4. Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3)
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brett D. Crist
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brett D. Crist, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402995
- Sponsor's protocol ID
- 2086908
- Status last verified
- Mar 2024
- First submitted
- 5 Apr 2022
- Last updated
- 24 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Control Trial Comparing Irrisept to Saline Irrigation for the Prevention of Infection After Open Tibia Fractures
- ClinicalTrials.gov ID
- NCT05402995
- Acronym / sponsor ID
- 2086908
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was not progressing as expected.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Brett D. CristUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Posted 24 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early debridement and definitive fixation, at the initial operative setting, historically led to no difference in the infection rates for Gustilo-Anderson type III open tibia fractures. However, Lenarz et al. reported that delaying definitive fixation in open tibia fractures could decrease the deep infection rate. At the University of Missouri, the investigators found that staged procedures, including initial debridement-temporary fixation and delayed definitive fixation, did not statistically decrease the rate of deep infection in Gustilo-Anderson type III fractures, prompting the study that is being proposed here. Antibiotic cement coated intramedullary nails have been used in management of infected long bone fractures. Since external fixation and staged debridement did not decrease type III open tibia infection rate, the investigators wanted to consider using antibiotic cement coated nails to deliver antibiotics locally in the acute open fracture setting to prophylactically decrease associated infection rate. Additionally, Irrisept is a wound irrigant that has been used to lower infection rates in different wound settings. To the investigators' knowledge, there are no robust data showing its effectiveness at lowering infection rates in open tibia fracture management. The purpose of this study is to determine the effects of Irrisept and antibiotic nails on lowering deep infection rates in type III open tibia fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be enrolled and randomized into one of four groups: 1. Standard operative debridement and spanning external fixator (reference/control group) 2. Spanning external fixator with Irrisept irrigation (treatment group 1) 3. Antibiotic-coated medullary nail with saline irrigation (treatment group 2) or 4. Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3)
| Arm | Type | Receives |
|---|---|---|
| Standard operative debridement and spanning external fixator (reference/control group) | Active comparator | Drug: SalineThis is the standard of care management. Patient will go to the operating room (OR) first for irrigation and debridement with normal saline and external fixation. Will return to OR at a later date for definitive fixation. |
| Spanning external fixator with Irrisept irrigation (treatment group 1) | Experimental | Drug: Irrisept (Irrigation Solution)Patient will go to the operating room (OR) first for irrigation and debridement with Irrisept (the experimental irrigation solution) and external fixation. Will return to OR at a later date for definitive fixation. |
| Antibiotic-coated medullary nail with saline irrigation (treatment group 2) | Experimental | Drug: SalinePatient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline. |
| Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3) | Experimental | Drug: Irrisept (Irrigation Solution)Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with Irrisept (the experimental irrigation solution). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult, 18 or over
- Gustilo-Anderson type III open tibia fracture
- Able to obtain informed consent from patient
Key exclusion criteria (7 listed)
- Minor, under 18
- Pregnancy
- Prisoner
- Allergic to chlorhexidine gluconate
- Allergic to vancomycin or tobramycin
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 |
|---|---|---|
| Irrisept (Irrigation Solution)Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds. | Drug | Antibiotic-coated medullary nail with Irrisept irrigation (treatment group 3), Spanning external fixator with Irrisept irrigation (treatment group 1) |
| SalineSaline irrigation | Drug | Antibiotic-coated medullary nail with saline irrigation (treatment group 2), Standard operative debridement and spanning external fixator (reference/control group) |
Primary outcome
Number of Participants Experiencing Surgical Site Infection (SSI)
Time frame: 90 days
Measured by the number of surgical site infections in the total population of patients.
1 secondary outcome
Number of Participants With Fracture Healing
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Irrisept (Irrigation Solution) and Saline in people with Gustilo-Anderson Type III Open Tibia Fracture, run by Brett D. Crist 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 7 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 24 Apr 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 24 Apr 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 Experiencing Surgical Site Infection (SSI) (time frame: 90 days). 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 24 Apr 2024.