A Phase 4 interventional study of Irrisept (Irrigation Solution) and Saline in Gustilo-Anderson Type III Open Tibia Fracture, sponsored by Brett D. Crist. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Brett D. Crist · Phase 4, Interventional, and Treatment
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.
159 studies on the registry are indexed under Tibial Fractures; 40 are open to participants now.
This study's enrollment of 6 is below the median of 60 across 105 interventional studies indexed under Tibial Fractures.
Browse Tibial Fractures studies →This is the only study on the registry with Brett D. Crist as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Saline
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.
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 normal saline.
Drug: Saline
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).
Drug: Irrisept (Irrigation Solution)
Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
Saline irrigation
Number of Participants Experiencing Surgical Site Infection (SSI)
Measured by the number of surgical site infections in the total population of patients.
Time frame: 90 days
Number of Participants With Fracture Healing
Presence or absence of fracture callous measured on x-ray by an experienced orthopaedic surgeon.
Time frame: 6 months
| Milestone | Standard Operative Debridement and Spanning External Fixator (Reference/Control Group) | Spanning External Fixator With Irrisept Irrigation (Treatment Group 1) | Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2) | Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3) |
|---|---|---|---|---|
| Started | 0 | 2 | 2 | 2 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 0 | 2 | 2 | 2 |
| Withdrew: Study terminated due to lack of enrollment and followup. | 0 | 2 | 2 | 2 |
Measured by the number of surgical site infections in the total population of patients.
| Participants | Standard Operative Debridement and Spanning External Fixator (Reference/Control Group) | Spanning External Fixator With Irrisept Irrigation (Treatment Group 1) | Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2) | Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3) |
|---|---|---|---|---|
| Number of Participants Experiencing Surgical Site Infection (SSI) | 0 | 0 | 0 | 0 |
Presence or absence of fracture callous measured on x-ray by an experienced orthopaedic surgeon.
No measurements were reported for this outcome.
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Operative Debridement and Spanning External Fixator (Reference/Control Group) | — | — | — |
| Spanning External Fixator With Irrisept Irrigation (Treatment Group 1) | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2) | 0/2 (0%) | 1/2 (50%) | 0/2 (0%) |
| Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3) | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Event | Standard Operative Debridement and Spanning External Fixator (Reference/Control Group) | Spanning External Fixator With Irrisept Irrigation (Treatment Group 1) | Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2) | Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3) |
|---|---|---|---|---|
| AmputationMusculoskeletal and connective tissue disorders | — | 0/2 | 1/2 | 0/2 |
As study was terminated due to difficulty enrolling participants there was no one randomized to the reference/control group.
| Age, Categorical(Participants) | Standard Operative Debridement and Spanning External Fixator (Reference/Control Group) | Spanning External Fixator With Irrisept Irrigation (Treatment Group 1) | Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2) | Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3) | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 2 | 2 | 1 | 5 |
| >=65 years | 0 | 0 | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Standard Operative Debridement and Spanning External Fixator (Reference/Control Group) | Spanning External Fixator With Irrisept Irrigation (Treatment Group 1) | Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2) | Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3) | Total |
|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 1 | 1 |
| Male | 0 | 2 | 2 | 1 | 5 |
| Race and Ethnicity Not Collected(Participants) | Standard Operative Debridement and Spanning External Fixator (Reference/Control Group) | Spanning External Fixator With Irrisept Irrigation (Treatment Group 1) | Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2) | Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3) | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(Participants) | Standard Operative Debridement and Spanning External Fixator (Reference/Control Group) | Spanning External Fixator With Irrisept Irrigation (Treatment Group 1) | Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2) | Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3) | Total |
|---|---|---|---|---|---|
| United States | — | 2 | 2 | 2 | 6 |
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