AzTrials
AzTrials

Surgical Site InfectionPhase 4Aqueous-PREPNCT03385304

Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures

A Phase 4 study testing 10% povidone-iodine (1% free iodine) in purified water and 4% chlorhexidine gluconate (CHG) in purified water in people with Surgical Site Infection and Unplanned Fracture-Related Reoperation, run by University of Maryland, Baltimore at 15 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
10% povidone-iodine (1% free iodine) in purified water and 4% chlorhexidine gluconate (CHG) in purified water
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,638 participants
Where
15 sitesin 3 countries
Study dates
8 Apr 2018to 27 Jun 2022
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

The inclusion criteria are:

  1. Patients 18 years of age or older.
  2. Open fracture of the appendicular skeleton.
  3. Received or will receive definitive fracture treatment with a surgical implant(s) (e.g., internal fixation, external fixation, joint prosthesis, etc.).
  4. Open fracture wound management that includes formal surgical debridement within 72 hours of their injury.
  5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
  6. Informed consent obtained.
  7. Patient enrolled within 3 weeks of their fracture.

The exclusion criteria are:

  1. Patients that did not or will not receive the allocated pre-operative surgical preparation solution due to a medical contraindication.
  2. Received previous surgical debridement or management of their open fracture at a non-participating hospital or clinic.
  3. Open fracture managed outside of the participating orthopaedic service (e.g., hand fracture managed by plastic surgeon).
  4. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
  5. Burns at the fracture site.
  6. Incarceration.
  7. Expected injury survival of less than 90 days.
  8. Terminal illness with expected survival less than 90 days.
  9. Previous enrollment in a PREP-IT trial.
  10. Currently enrolled in a study that does not permit co-enrollment.
  11. Unable to obtain informed consent due to language barriers.
  12. Likely problems, in the judgment of study personnel, with maintaining follow-up with the patient.
  13. Excluded due to sampling strategy.

Trial locations and contacts

15 sites in 3 countries.

15 sites in 3 countries

United States11 sites

  • University of Maryland, R Adams Cowley Shock Trauma Center

    Baltimore, Maryland, 21201

  • Wright State University / Miami Valley Hospital

    Dayton, Ohio, 45409

  • San Antonio Military Medical Center

    Fort Sam Houston, Texas, 78234

  • University of Florida

    Gainesville, Florida, 32611

  • Greenville Health System

    Greenville, South Carolina, 29605

  • McGovern Medical School at University of Texas Health Science Center Houston

    Houston, Texas, 77030

  • Indiana University Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • Vanderbilt University

    Nashville, Tennessee, 37240

  • The CORE Institute / Banner University Medical Center

    Phoenix, Arizona, 85006

  • University of California San Francisco

    San Francisco, California, 94143

  • Banner - University Medical Center Tucson

    Tucson, Arizona, 85721

Other trials in United States

Canada2 sites

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L 2X2

  • McMaster University, Center for Evidence-Based Orthopaedics

    Hamilton, Ontario, L8L 8E7

Other trials in Canada

Spain2 sites

  • Hospital Parc Tauli de Sabadell

    Barcelona

  • Vall d'Hebron University Hospital

    Barcelona

Other trials in Spain

About this study

Official title: Aqueous-PREP: A Pragmatic Randomized Trial Evaluating Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures

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.

Being tested
10% povidone-iodine (1% free iodine) in purified water, 4% chlorhexidine gluconate (CHG) in purified water
Keywords
Surgical Site Infection, Open Fracture, Povidone-iodine, Chlorhexidine gluconate, Peri-operative Preparation Solutions
Medical subject headings
Surgical Wound Infection, Fractures, Open

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 10% povidone-iodine (1% free iodine) in purified waterDrug

    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 waterDrug

    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.

Study groups in NCT03385304
Study groupRoleWhat they receive
10% povidone-iodine (1% free iodine) in purified waterExperimentalThe 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.).
Receives: Drug: 10% povidone-iodine (1% free iodine) in purified water; Drug: 4% chlorhexidine gluconate (CHG) in purified water
4% chlorhexidine gluconate (CHG) in purified waterExperimentalThe 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.).
Receives: Drug: 10% povidone-iodine (1% free iodine) in purified water; Drug: 4% chlorhexidine gluconate (CHG) in purified water

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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:

    1. purulent drainage from the superficial incision.
    2. organisms identified from an aseptically obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment
    3. superficial incision that is deliberately opened by a surgeon, and culture or non-culture-based testing is not performed. AND patient has at least one of the following signs or symptoms: pain or tenderness; localized swelling; erythema; or heat.
    4. diagnosis of a superficial incisional SSI by the surgeon.

    Measured: Within 30 days of the patient's last planned fracture management surgery

  2. 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:

    1. deep incision purulent drainage
    2. a deep incision that dehisces, or is opened by a surgeon, and organism is identified by microbiologic testing; or microbiologic testing is not performed \& has at least one of the following: fever (> 38 °C); localized pain or tenderness
    3. other evidence of deep incision infection on anatomical exam or imaging test

    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:

    1. organ/space purulent drainage
    2. organisms in organ/space identified by microbiologic testing
    3. other evidence of organ/space infection on anatomical exam or imaging test

    Measured: Within 90 days of the patient's last planned fracture management surgery

Secondary outcomes (1)

  1. 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.

    Measured: Within 12 months of the patient's last planned operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2017
  2. Study start8 Apr 2018
  3. Primary completion19 Oct 2021
  4. Study completion27 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,638 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03385304
Sponsor's protocol ID
HP-00078470
Acronym
Aqueous-PREP
Status last verified
Mar 2023
First submitted
20 Dec 2017
Last updated
31 Mar 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36096826

  • 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.

    PubMed 36244384

  • 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.

    PubMed 33648577

  • 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.

    PubMed 32787892

  • 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.

    PubMed 32259266

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 10% povidone-iodine (1% free iodine) in purified water and 4% chlorhexidine gluconate (CHG) in purified water in people with Surgical Site Infection and Unplanned Fracture-Related Reoperation, run by University of Maryland, Baltimore at 15 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) (time frame: Within 30 days of the patient's last planned fracture management surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03385304, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in