Pre-operative Alcohol Skin Solutions in Fractured Extremities

Surgical Site Infection Clinical Trial

— PREPARE  

Official title:

PREPARE: A Pragmatic Randomized Trial Evaluating Pre-operative Alcohol Skin Solutions in FRactured Extremites

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03523962
• Other study ID #: HP-00080639
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 21, 2018
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The prevention of infection is an important goal influencing peri-operative care of extremity fracture patients. Standard practice in the operative management of extremity 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 extremity fracture surgery.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8000
• Est. completion date: December 2024
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

The open fracture 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) (i.e., 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 open fracture exclusion criteria are:

1. Fracture of the hand (distal to radial carpal joint).

2. Patients who did not or will not receive the allocated pre-operative surgical preparation solution due to a medical contraindication.

3. Received previous surgical debridement or management of their fracture at a nonparticipating hospital or clinic (as applicable).

4. Open fracture managed outside of the participating orthopaedic service (e.g., foot fracture managed by podiatrist).

5. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.

6. Burns at the fracture site.

7. Incarceration.

8. Expected injury survival of less than 90 days.

9. Terminal illness with expected survival less than 90 days.

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. Prior or current enrollment in a PREP-IT trial.

14. Enrolled in the PREPARE closed cohort.

15. Excluded due to sampling strategy.

The closed fracture inclusion criteria are:

1. Patients 18 years of age or older.

2. Closed fracture of the lower extremity or pelvis.

3. Received or will receive definitive fracture treatment with a surgical implant(s) (i.e., internal fixation, external fixation, joint prosthesis, etc.).

4. Fracture management requires a surgical incision (i.e., for fracture reduction or implant insertion).

5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate.

6. Informed consent obtained.

7. Patient enrolled within 6 weeks of their fracture.

The closed fracture exclusion criteria are:

1. Patients who did not or will not receive the allocated pre-operative surgical preparation solution due to a medical contraindication.

2. Received previous surgical management of their fracture at a non-participating hospital or clinic.

3. Fracture managed outside of the participating orthopaedic service (e.g., foot fracture managed by podiatrist).

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. Currently enrolled in a study that does not permit co-enrollment.

10. Unable to obtain informed consent due to language barriers.

11. Likely, problems, in the judgment of study personnel, with maintaining follow-up with the patient.

12. Prior or current enrollment in a PREP-IT trial.

13. Enrolled in the PREPARE open cohort.

14. Excluded due to sampling strategy.

Related Conditions & MeSH terms

• Closed Lower Extremity Fracture
• Fractures, Bone
• Hip Fractures
• Open Appendicular Fracture
• Pelvic Fracture
• Surgical Site Infection
• Surgical Wound Infection
• Unplanned Fracture-Related Reoperation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	McMaster University, Center for Evidence-Based Orthopaedics	Hamilton	Ontario
Canada	Royal Columbia Hospital	New Westminster	British Columbia
United States	University of Maryland, R Adams Cowley Shock Trauma Center	Baltimore	Maryland
United States	Louisiana State University	Baton Rouge	Louisiana
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Carolinas Medical Center, Atrium Health Musculoskeletal Institute	Charlotte	North Carolina
United States	University of Maryland Capital Region Health	Cheverly	Maryland
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Case Western / MetroHealth Medical Center	Cleveland	Ohio
United States	Duke University Hospital	Durham	North Carolina
United States	Inova Health System Foundation / Inova Fairfax Hospital	Falls Church	Virginia
United States	Greenville Health System	Greenville	South Carolina
United States	Dartmouth-Hitchcock Medical Center	Hanover	New Hampshire
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana
United States	University of California, Irvine	Irvine	California
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Bryan Health	Lincoln	Nebraska
United States	Cedars Sinai	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Utah	Salt Lake City	Utah
United States	San Antonio Military Medical Center	San Antonio	Texas
United States	Regional Medical Center of San Jose	San Jose	California
United States	Sanford Health	Sioux Falls	South Dakota
United States	Wake Forest Baptist University Medical Center	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	McMaster University, Patient-Centered Outcomes Research Institute

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infection: Superficial Incisional	Guided by the CDC's National Healthcare Safety Network reporting criteria	Within 30 days of the patient's last planned fracture management surgery
Primary	Surgical Site Infection: Deep Incision or Organ/Space	Guided by the CDC's National Healthcare Safety Network reporting criteria	Within 90 days of the patient's last planned fracture management surgery
Secondary	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