Pre-operative Alcohol Skin Solutions in Fractured Extremities (PREPARE)
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| ClinicalTrials.gov Identifier: NCT03523962 |
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Recruitment Status :
Active, not recruiting
First Posted : May 14, 2018
Last Update Posted : May 9, 2023
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| Condition or disease | Intervention/treatment | Phase |
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| Surgical Site Infection Unplanned Fracture-Related Reoperation Open Appendicular Fracture Closed Lower Extremity Fracture Pelvic Fracture | Drug: DuraPrep Drug: ChloraPrep | Phase 4 |
More than one million Americans suffer an extremity fracture (broken bone in the arm, leg, or pelvis) that requires surgery each year. Approximately 5% (or 50,000) of surgical fracture patients develop a surgical site infection (SSI), which is twice the rate among most surgical patients and nearly five times the rate among patients undergoing elective orthopaedic surgeries (e.g. joint replacement). Patients who develop a SSI after their fracture fixation surgery experience a long and difficult treatment pathway. Researchers have identified that when a fracture patient experiences a SSI, they typically undergo at least two additional surgeries to control the infection, spend a median of 14 additional days in the hospital, and have significantly lower health related quality of life (HRQL). Similarly, results from the recently completed Fluid Lavage of Open Wounds (FLOW) trial confirmed that patients who had a SSI, or another complication, that required an additional surgery reported significantly lower physical and mental HRQL in the 12 months following their fracture compared to patients who did not experience a SSI. In the most severe cases, when a SSI cannot be controlled, a limb amputation becomes necessary.
Open fractures, closed lower extremity fractures, and pelvic fractures represent some of the most severe musculoskeletal injuries. Due to their high-energy mechanisms, these fractures are often accompanied by soft-tissue injuries that contribute to unacceptably poor outcomes. The FLOW trial of 2,447 open fracture patients reported a 13.2% incidence of open fracture-related reoperations; Closed fractures of the lower extremity are also at high risk of complications, particularly when compared to closed upper extremity fractures. For example, the rate of SSI in closed tibial plateau and plafond fractures range from 5.6 - 11.9%, although some cohort studies have reported infection rates as high as 25.0%. This is contrast with SSI rates of <5% for common upper extremity fractures like humeral shaft, forearm, or distal radius fractures. This is further illustrated in a series of 214 deep orthopaedic fracture infections, in which 58% occurred in the tibia and ankle, and only 10% occurred anywhere in the upper extremity. Finally, pelvic fractures are associated with some of the most challenging SSIs to treat among closed fractures because of their propensity to gram negative organisms and limitations in reconstruction options post-infection. Ultimately, infectious complications in these fracture populations lead to prolonged morbidity, loss of function, and potential limb loss.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 8000 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention Model Description: | Treatment allocation will be determined using a cluster-randomized crossover trial design. The open and closed fracture populations will be treated with the same allocated solution at all times during the trial. 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. |
| Masking: | Single (Outcomes Assessor) |
| Masking Description: | 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 iodine povacrylex, 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. |
| Primary Purpose: | Treatment |
| Official Title: | PREPARE: A Pragmatic Randomized Trial Evaluating Pre-operative Alcohol Skin Solutions in FRactured Extremites |
| Actual Study Start Date : | August 21, 2018 |
| Actual Primary Completion Date : | March 15, 2023 |
| Estimated Study Completion Date : | December 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: First pre-op antiseptic skin solution
The PREPARE trial will compare the most common alcohol-based pre-operative antiseptic skin solutions used during extremity fracture surgery. Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all eligible fracture surgeries for a two-month period.
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Drug: DuraPrep
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ [3M Health Care, St Paul, MN], will be the commercial product used. Drug: ChloraPrep The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® [CareFusion Inc., Leawood, KS, USA] will be the product used. |
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Experimental: Crossover - Second pre-op antiseptic skin solution
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 eligible fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
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Drug: DuraPrep
The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ [3M Health Care, St Paul, MN], will be the commercial product used. Drug: ChloraPrep The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® [CareFusion Inc., Leawood, KS, USA] will be the product used. |
- Surgical Site Infection: Superficial Incisional [ Time Frame: Within 30 days of the patient's last planned fracture management surgery ]Guided by the CDC's National Healthcare Safety Network reporting criteria
- Surgical Site Infection: Deep Incision or Organ/Space [ Time Frame: Within 90 days of the patient's last planned fracture management surgery ]Guided by the CDC's National Healthcare Safety Network reporting criteria
- Unplanned Fracture-Related Reoperation [ Time Frame: Within 12 months of the patient's last planned operation ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
The open fracture inclusion criteria are:
- Patients 18 years of age or older.
- Open fracture of the appendicular skeleton.
- Received or will receive definitive fracture treatment with a surgical implant(s) (i.e., internal fixation, external fixation, joint prosthesis, etc.).
- Open fracture wound management that includes formal surgical debridement within 72 hours of their injury.
- Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
- Informed consent obtained.
- Patient enrolled within 3 weeks of their fracture.
The open fracture exclusion criteria are:
- Fracture of the hand (distal to radial carpal joint).
- Patients who did not or will not receive the allocated pre-operative surgical preparation solution due to a medical contraindication.
- Received previous surgical debridement or management of their fracture at a nonparticipating hospital or clinic (as applicable).
- Open fracture managed outside of the participating orthopaedic service (e.g., foot fracture managed by podiatrist).
- Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
- Burns at the fracture site.
- Incarceration.
- Expected injury survival of less than 90 days.
- Terminal illness with expected survival less than 90 days.
- Currently enrolled in a study that does not permit co-enrollment.
- Unable to obtain informed consent due to language barriers.
- Likely problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- Prior or current enrollment in a PREP-IT trial.
- Enrolled in the PREPARE closed cohort.
- Excluded due to sampling strategy.
The closed fracture inclusion criteria are:
- Patients 18 years of age or older.
- Closed fracture of the lower extremity or pelvis.
- Received or will receive definitive fracture treatment with a surgical implant(s) (i.e., internal fixation, external fixation, joint prosthesis, etc.).
- Fracture management requires a surgical incision (i.e., for fracture reduction or implant insertion).
- Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
- Informed consent obtained.
- Patient enrolled within 6 weeks of their fracture.
The closed fracture exclusion criteria are:
- Patients who did not or will not receive the allocated pre-operative surgical preparation solution due to a medical contraindication.
- Received previous surgical management of their fracture at a non-participating hospital or clinic.
- Fracture managed outside of the participating orthopaedic service (e.g., foot fracture managed by podiatrist).
- Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
- Burns at the fracture site.
- Incarceration.
- Expected injury survival of less than 90 days.
- Terminal illness with expected survival less than 90 days.
- Currently enrolled in a study that does not permit co-enrollment.
- Unable to obtain informed consent due to language barriers.
- Likely, problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- Prior or current enrollment in a PREP-IT trial.
- Enrolled in the PREPARE open cohort.
- Excluded due to sampling strategy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523962
Show 27 study locations
| Principal Investigator: | Gerard Slobogean, MD | University of Maryland Shock Trauma Center | |
| Principal Investigator: | Sheila Sprague, PhD | McMaster University | |
| Principal Investigator: | Mohit Bhandari, MD | McMaster University |
Documents provided by Gerard Slobogean, University of Maryland, Baltimore:
| Responsible Party: | Gerard Slobogean, Assistant Professor, Department of Orthopaedics, University of Maryland, Baltimore |
| ClinicalTrials.gov Identifier: | NCT03523962 |
| Other Study ID Numbers: |
HP-00080639 |
| First Posted: | May 14, 2018 Key Record Dates |
| Last Update Posted: | May 9, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Surgical Site Infection Open Fracture Lower Extremity Fracture Pelvis; Fracture |
DuraPrep ChloraPrep Peri-operative Preparation Solutions |
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Surgical Wound Infection Fractures, Bone Hip Fractures Infections Wounds and Injuries Wound Infection |
Postoperative Complications Pathologic Processes Femoral Fractures Hip Injuries Leg Injuries |