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Alcohol Skin Solutions for Broken Bones (PREPARE Trial)
Phase 4
Waitlist Available
Led By Gerard Slobogean, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fracture management requires a surgical incision (i.e., for fracture reduction or implant insertion)
Open fracture of the appendicular skeleton
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days of the patient's last planned fracture management surgery
Awards & highlights
PREPARE Trial Summary
This trial is testing different solutions to see which one is the best at preventing infection in people with broken bones.
Who is the study for?
Adults over 18 with open fractures needing surgery within 72 hours of injury can join. They must be treated by a participating surgeon, consent to the study, and not be in conflicting trials or have communication barriers.Check my eligibility
What is being tested?
The trial is testing two skin cleaning solutions, DuraPrep and ChloraPrep, used before surgery on broken bones to prevent infections. It aims to find out which one is better at reducing bacteria and infection risks.See study design
What are the potential side effects?
Potential side effects from DuraPrep and ChloraPrep may include skin irritation or allergic reactions at the application site. However, these are generally mild as they're topical antiseptics.
PREPARE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need surgery for a fracture.
Select...
I have a broken bone that is exposed through my skin.
Select...
I have had or will have surgery to fix a bone fracture using implants.
Select...
My fracture surgery will be done by a surgeon in the trial.
Select...
I have a closed fracture in my leg or pelvis.
PREPARE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 days of the patient's last planned fracture management surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days of the patient's last planned fracture management surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Surgical Site Infection: Deep Incision or Organ/Space
Surgical Site Infection: Superficial Incisional
Secondary outcome measures
Unplanned Fracture-Related Reoperation
PREPARE Trial Design
2Treatment groups
Experimental Treatment
Group I: First pre-op antiseptic skin solutionExperimental Treatment2 Interventions
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.
Group II: Crossover - Second pre-op antiseptic skin solutionExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DuraPrep
2010
Completed Phase 4
~230
Isopropyl alcohol
FDA approved
Find a Location
Who is running the clinical trial?
McMaster UniversityOTHER
880 Previous Clinical Trials
2,589,828 Total Patients Enrolled
University of Maryland, BaltimoreLead Sponsor
687 Previous Clinical Trials
366,646 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
549 Previous Clinical Trials
29,988,776 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My fracture was treated by a specialist outside of the orthopedic team.I have burns at the site of my fracture.I need surgery for a fracture.I am 18 years old or older.I have a broken bone that is exposed through my skin.I have a broken bone in my hand below the wrist.I have had or will have surgery to fix a bone fracture using implants.My fracture surgery will be done by a surgeon in the trial.I had surgery or fracture management at a hospital not part of this study.I had surgery for my fracture at a hospital or clinic not involved in this study.I cannot use certain pre-surgery solutions due to health reasons.I have an infection at or near where my bone was broken and first treated.I enrolled in the study within 3 weeks of breaking a bone.My open fracture was treated by a specialist outside of the orthopedic team.I had surgery to clean my open fracture within 3 days of injury.I have a closed fracture in my leg or pelvis.
Research Study Groups:
This trial has the following groups:- Group 1: Crossover - Second pre-op antiseptic skin solution
- Group 2: First pre-op antiseptic skin solution
Awards:
This trial has 5 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are enrolled in this experiment?
"Enrollment for this medical trial has been halted. It was initially posted on August 21st of 2018 and edited most recently on November 8th 2022. If you are looking to participate in a clinical study, there are currently 431 trials related to unplanned fracture-related reoperation that need participants as well as 47 studies focused on DuraPrep."
Answered by AI
How prevalent is this empirical research in our state?
"Patients are currently being accepted into this trial at the University of Cincinnati Medical Centre, Bryan Health in Lincoln, Nebraska and Royal Columbia Hospital in New Westminster, British Columbia. Additionally, there are 24 other locations participating in the study."
Answered by AI
To what ailments is DuraPrep regularly administered?
"DuraPrep is commonly used to create antisepsis, but it has additional applications such as disinfection and treating injuries in the throat or pressure ulcers."
Answered by AI
Is the team behind this study still seeking participants?
"Per the data on clinicaltrials.gov, this particular study is not actively seeking applicants at present. The trial was first posted in August 2018 and most recently updated in November 2022. Nonetheless, there are currently 478 other medical trials recruiting volunteers around the world right now."
Answered by AI
Is DuraPrep an accepted medical device by the Food and Drug Administration?
"Our team at Power rated DuraPrep's safety a 3 on the scale, signifying that this intervention has been officially approved by regulatory authorities."
Answered by AI
What other research initiatives have been launched to analyze the efficacy of DuraPrep?
"Currently, 47 trials are underway regarding DuraPrep. Of those clinical investigations, 18 have entered Phase 3. Although the main research is conducted in Bialystok, Podlaskie, a total of 2768 sites worldwide offer this particular treatment trial."
Answered by AI
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