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| Name | Class |
|---|---|
| McMaster University | OTHER |
| United States Department of Defense | FED |
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The prevention of infection is the single most important goal influencing peri-operative care of patients with open fractures. Standard practice in the management of open fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution. The available solutions kill bacteria and decrease the quantity of native skin flora, thereby decreasing surgical site infection (SSI). While there is extensive guidance on specific procedures for prophylactic antibiotic use and standards for sterile technique, the evidence regarding the choice of antiseptic skin preparation solution is very limited for open fracture surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10% povidone-iodine (1% free iodine) in purified water | Experimental | The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.). |
|
| 4% chlorhexidine gluconate (CHG) in purified water | Experimental | The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10% povidone-iodine (1% free iodine) in purified water | Drug | Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) | Guided by the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network reporting criteria (2017): Date of event for infection may occur from the date of fracture to 30 days after the definitive fracture management surgery; AND involves only skin and subcutaneous tissue of the incision; AND patient has at least one of the following:
| Within 30 days of the patient's last planned fracture management surgery |
| Number of Participants With a Deep Incisional or Organ/Space Infection | Guided by CDC's National Healthcare Safety Network Surgical Site Infection reporting criteria (2017): Deep Incisional Infection: Occurs within 90 days post definitive fracture management; & involves fascial/muscle layers; & has at least one of the following:
Organ/Space Infection: Occurs within 90 days post definitive fracture management; & involves any part of the body deeper than the fascial/muscle layers; & has at least one of the following:
| Within 90 days of the patient's last planned fracture management surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Unplanned Fracture-Related Reoperation | Common examples include any unplanned fracture-related surgery that is associated with an infection at the operative site or contiguous to it, a wound-healing problem, or a fracture delayed union or non-union. | Within 12 months of the patient's last planned operation |
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The inclusion criteria are:
The exclusion criteria are:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Slobogean, MD | University of Maryland, Baltimore | Principal Investigator |
| Sheila Sprague, PhD | McMaster University | Principal Investigator |
| Mohit Bhandari, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The CORE Institute / Banner University Medical Center | Phoenix | Arizona | 85006 | United States | ||
| Banner - University Medical Center Tucson |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36096826 | Background | O'Hara NN, Heels-Ansdell D, Bzovsky S, Dodds S, Thabane L, Bhandari M, Guyatt G, Devereaux PJ, Slobogean GP, Sprague S; PREP-IT Investigators. A pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solutions in open fractures (Aqueous-PREP): statistical analysis plan. Trials. 2022 Sep 12;23(1):772. doi: 10.1186/s13063-022-06541-0. | |
| 36244384 |
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To ensure wide generalizability to routine practice, the protocol allowed prewashing of the operative extremity with alcohol or other antiseptics before performing the final skin antisepsis with the study solution. In addition to ensuring trial feasibility and protocol adherence, this decision pragmatically allowed the intact skin to receive mechanical scrubbing or partial alcohol antisepsis at the treating surgeon's discretion.
Recruitment occurred between April 8, 2018, and June 8, 2021 at 14 hospitals in Canada, Spain and the USA. Eligible patients were adults aged 18 years or older with an open extremity fracture treated with a surgical fixation implant. For inclusion, the open fracture required formal surgical debridement within 72 hours of the injury.
| ID | Title | Description |
|---|---|---|
| FG000 | 10% Povidone-iodine (1% Free Iodine) in Purified Water | The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.). 10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period. 4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Nov 4, 2019 |
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Treatment allocation will be determined using a cluster-randomized crossover trial design. The order of treatment allocation for each orthopaedic practice will be randomly assigned using a computer generated randomization table. Each site will start with the initially allocated study solution and eventually crossover to the other solution for their second recruitment period. This process of alternating treatments will repeat approximately every 2 months as dictated by the initial randomization.
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The orthopaedic team (including the study coordinators) cannot be blinded to the treatment allocation as the antiseptic solutions are visually distinguishable and these individuals need to lead the implementation of the cluster-crossover protocol at their clinical site. The Adjudication Committee Members and data analysts will be blinded to the study treatment. All interpretation of study results will initially be done in a blinded manner by developing two interpretations of the results. One interpretation will assume treatment A is povidone-iodine, the other interpretation will assume it is CHG. Once the data interpretations for each assumption are finalized, the data will be unblinded and the correct interpretation will be accepted.
| 4% chlorhexidine gluconate (CHG) in purified water | Drug | Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase. |
|
| Tucson |
| Arizona |
| 85721 |
| United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| University of Florida | Gainesville | Florida | 32611 | United States |
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| University of Maryland, R Adams Cowley Shock Trauma Center | Baltimore | Maryland | 21201 | United States |
| Wright State University / Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Greenville Health System | Greenville | South Carolina | 29605 | United States |
| Vanderbilt University | Nashville | Tennessee | 37240 | United States |
| San Antonio Military Medical Center | Fort Sam Houston | Texas | 78234 | United States |
| McGovern Medical School at University of Texas Health Science Center Houston | Houston | Texas | 77030 | United States |
| Hamilton Health Sciences | Hamilton | Ontario | L8L 2X2 | Canada |
| McMaster University, Center for Evidence-Based Orthopaedics | Hamilton | Ontario | L8L 8E7 | Canada |
| Hospital Parc Tauli de Sabadell | Barcelona | Spain |
| Vall d'Hebron University Hospital | Barcelona | Spain |
| PREP-IT Investigators. Aqueous skin antisepsis before surgical fixation of open fractures (Aqueous-PREP): a multiple-period, cluster-randomised, crossover trial. Lancet. 2022 Oct 15;400(10360):1334-1344. doi: 10.1016/S0140-6736(22)01652-X. |
| 33648577 | Derived | Sprague S, Guyatt P, Bzovsky S, Nguyen U, Bhandari M, Thabane L, Petrisor B, Johal HS, Leonard J, Dodds S, Mossuto F, O'Toole RV, Howe A, Demyanovich HK, Camara M, O'Hara NN, Slobogean GP; PREP-IT Investigators. Pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solution in open fractures (Aqueous-PREP): the feasibility of a cluster randomized crossover study. Pilot Feasibility Stud. 2021 Mar 1;7(1):61. doi: 10.1186/s40814-021-00800-8. |
| 32787892 | Derived | Sprague S, Scott T, Dodds S, Pogorzelski D, McKay P, Harris AD, Wood A, Thabane L, Bhandari M, Mehta S, Gaski G, Boulton C, Marcano-Fernandez F, Guerra-Farfan E, Hebden J, O'Hara LM, Slobogean GP; PREP-IT Investigators. Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials. Trials. 2020 Aug 12;21(1):712. doi: 10.1186/s13063-020-04611-9. |
| 32259266 | Derived | Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma (PREP-IT) Investigators; Slobogean GP, Sprague S, Wells J, Bhandari M, Rojas A, Garibaldi A, Wood A, Howe A, Harris AD, Petrisor BA, Mullins DC, Pogorzelski D, Marvel D, Heels-Ansdell D, Mossuto F, Grissom F, Del Fabbro G, Guyatt GH, Della Rocca GJ, Demyanovich HK, Gitajn IL, Palmer J, D'Alleyrand JC, Friedrich J, Rivera J, Hebden J, Rudnicki J, Fowler J, Jeray KJ, Thabane L, Marchand L, O'Hara LM, Joshi MG, Talbot M, Camara M, Szasz OP, O'Hara NN, McKay P, Devereaux PJ, O'Toole RV, Zura R, Morshed S, Dodds S, Li S, Tanner SL, Scott T, Nguyen U. Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol. JAMA Netw Open. 2020 Apr 1;3(4):e202215. doi: 10.1001/jamanetworkopen.2020.2215. |
| FG001 | 4% Chlorhexidine Gluconate (CHG) in Purified Water | The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.). 10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period. 4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase. |
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| Months 1-2 |
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| Months 3-4 |
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| Months 5-6 |
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| Months 7-8 |
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| Months 9-10 |
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| Months 11-12 |
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| Months 13-14 |
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| Months 15-16 |
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| Months 17-18 |
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| Months 19-20 |
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| Months 21-22 |
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| Months 23-24 |
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| Months 25-26 |
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| Months 27-28 |
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| Months 29-30 |
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| Months 31-32 |
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| COMPLETED | Total Study Duration |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 10% Povidone-iodine (1% Free Iodine) in Purified Water | The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.). 10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period. 4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase. |
| BG001 | 4% Chlorhexidine Gluconate (CHG) in Purified Water | The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.). 10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period. 4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| BMI | BMI (Body Mass Index) [kg/m^2] was determined by collecting each participant's weight and height | Count of Participants | Participants |
| |||||||||||||||
| Diabetes of any type | Count of Participants | Participants |
| ||||||||||||||||
| Current smoker | Count of Participants | Participants |
| ||||||||||||||||
| American Society of Anesthesiologist (ASA) Physical Score | The American Society of Anesthesiologist (ASA) score is a subjective assessment of a patient's overall health that is based on five classes (I to V). I. Patient is a completely healthy fit patient. II. Patient has mild systemic disease. III. Patient has severe systemic disease that is not incapacitating. IV. Patient has incapacitating disease that is a constant threat to life. V. A moribund patient who is not expected to live 24 hour with or without surgery. | Count of Participants | Participants |
| |||||||||||||||
| Number of included open fractures per participant | Count of Participants | 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 With a Superficial Incisional Surgical Site Infection (SSI) | Guided by the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network reporting criteria (2017): Date of event for infection may occur from the date of fracture to 30 days after the definitive fracture management surgery; AND involves only skin and subcutaneous tissue of the incision; AND patient has at least one of the following:
| Posted | Count of Participants | Participants | Within 30 days of the patient's last planned fracture management surgery |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants With a Deep Incisional or Organ/Space Infection | Guided by CDC's National Healthcare Safety Network Surgical Site Infection reporting criteria (2017): Deep Incisional Infection: Occurs within 90 days post definitive fracture management; & involves fascial/muscle layers; & has at least one of the following:
Organ/Space Infection: Occurs within 90 days post definitive fracture management; & involves any part of the body deeper than the fascial/muscle layers; & has at least one of the following:
| Posted | Count of Participants | Participants | Within 90 days of the patient's last planned fracture management surgery |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With an Unplanned Fracture-Related Reoperation | Common examples include any unplanned fracture-related surgery that is associated with an infection at the operative site or contiguous to it, a wound-healing problem, or a fracture delayed union or non-union. | Primary and secondary outcomes were evaluated using a complete case analysis. For that reason, the overall number of participants analyzed differs from the numbers provided under the Participant Flow module. | Posted | Count of Participants | Participants | Within 12 months of the patient's last planned operation |
|
1 year post injury
This study did not collect data regarding "Other (Not Including Serious) Adverse Events".
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10% Povidone-iodine (1% Free Iodine) in Purified Water | The povidone-iodine solution will contain 10% povidone-iodine (1% free iodine) in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions for use (e.g., technique of application, duration of application, drying time, drying techniques, replacement of draping, etc.). 10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period. 4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase. | 19 | 828 | 365 | 828 | 0 | 0 |
| EG001 | 4% Chlorhexidine Gluconate (CHG) in Purified Water | The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.). 10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period. 4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase. | 7 | 810 | 368 | 810 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Study Fracture Related Complication | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Non-Study Fracture Related Complication | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neurological | Nervous system disorders | Systematic Assessment |
| ||
| Renal | Renal and urinary disorders | Systematic Assessment |
| ||
| Cardiac | Cardiac disorders | Systematic Assessment |
| ||
| Vascular | Vascular disorders | Systematic Assessment |
| ||
| Gastro-Intestinal | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Other | General disorders | Systematic Assessment |
|
Not provided
The uncontrolled use of adjunctive skin preparations before final antisepsis is a potential limitation of our study design. Although the use of a prewash with adjunctive alcohol was similarly distributed between the treatment groups, post-randomization confounding from this practice might exist. The trial has other limitations, including unmasked treatment allocation and the decision to initiate each recruitment site as soon as possible.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Administrator | University of Maryland, Baltimore | 410-706-6823 | ahowe@som.umaryland.edu |
| Nov 8, 2022 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D005597 | Fractures, Open |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| C010882 | chlorhexidine gluconate |
| D002864 | Chromogranins |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
Not provided
Not provided
| Male |
|
| Black |
|
| Central or South American |
|
| Asian |
|
| Prefer not to answer |
|
| Indigenous |
|
| Multiracial |
|
| Native Hawaiian or Pacific Islander |
|
| Healthy weight (18.5 - 24.9 kg/m^2) |
|
| Overweight (25.0-29.9 kg/m^2) |
|
| Obesity (>30.0 kg/m^2) |
|
| Class III or higher |
|
| Two |
|
| Three |
|
| OG001 | 4% Chlorhexidine Gluconate (CHG) in Purified Water | The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.). 10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period. 4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase. |
|
|
| OG001 | 4% Chlorhexidine Gluconate (CHG) in Purified Water | The CHG solution will contain 4% CHG in purified water as the only active ingredient. Operating room personnel will apply the solution to the operative site as the final preoperative skin antisepsis preparation immediately prior to commencing surgical fixation. They will apply the solution as per manufacturer's directions (e.g., technique of application, duration of application, drying time, replacement of draping, etc.). 10% povidone-iodine (1% free iodine) in purified water: Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period. 4% chlorhexidine gluconate (CHG) in purified water: Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase. |
|
|