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Enrollment was not progressing as expected.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Surgical Site Infection (SSI) | Measured by the number of surgical site infections in the total population of patients. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Fracture Healing | Presence or absence of fracture callous measured on x-ray by an experienced orthopaedic surgeon. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Health System | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Operative Debridement and Spanning External Fixator (Reference/Control Group) | 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. Saline: Saline irrigation |
| FG001 | Spanning External Fixator With Irrisept Irrigation (Treatment Group 1) | 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. Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds. |
| FG002 | Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2) | Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline. Saline: Saline irrigation |
| FG003 | Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3) | 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). Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
As study was terminated due to difficulty enrolling participants there was no one randomized to the reference/control group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Operative Debridement and Spanning External Fixator (Reference/Control Group) | 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. Saline: Saline irrigation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing Surgical Site Infection (SSI) | Measured by the number of surgical site infections in the total population of patients. | As study was terminated due to difficulty enrolling participants there was no one randomized to the reference/control group. | Posted | Count of Participants | Participants | 90 days |
|
1 year
There is a minimal increased risk of reaction to chlorhexidine gluconate in the Irrisept treatment group which may include allergic reaction or irritation therefore adverse event / serious adverse events are not anticipated and would be considered a result of the injury sustained.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Operative Debridement and Spanning External Fixator (Reference/Control Group) | 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. Saline: Saline irrigation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amputation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vicki L Jones | UMissouri | 573-882-7583 | jonesvicki@health.missouri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 4, 2023 | Nov 29, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Participants will be enrolled and randomized into one of four groups:
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| Saline | Drug | Saline irrigation |
|
| BG001 |
| Spanning External Fixator With Irrisept Irrigation (Treatment Group 1) |
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. Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds. |
| BG002 | Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2) | Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline. Saline: Saline irrigation |
| BG003 | Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3) | 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). Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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. Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds. |
| OG002 | Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2) | Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline. Saline: Saline irrigation |
| OG003 | Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3) | 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). Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds. |
|
|
| Secondary | Number of Participants With Fracture Healing | Presence or absence of fracture callous measured on x-ray by an experienced orthopaedic surgeon. | As study was terminated due to difficulty enrolling participants there was no one randomized to the reference/control group. Unable to measure presence or absence of fracture callus due to lack of follow-up with study termination. | Posted | 6 months |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Spanning External Fixator With Irrisept Irrigation (Treatment Group 1) | 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. Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2) | Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline. Saline: Saline irrigation | 0 | 2 | 1 | 2 | 0 | 2 |
| EG003 | Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3) | 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). Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D017670 |
| Sodium Compounds |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|