Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy

Open tíbia Fracture Clinical Trial

— BeadsvsVac  

Official title:

A Randomized Controlled Trial Comparing Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy for the Management of Severe Open Tibia Fracture Wounds

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05615844
• Other study ID #: VVB-001-2022
• Status: Recruiting
• Phase: Phase 3
• Start date: November 5, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: June 2024
• Source: University of Maryland, Baltimore
• Contact: Heather Phipps, MPS
• Phone: 410-706-2492
• Email: hphipps[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Beads vs Vac trial is a multi-centre randomized controlled trial of 312 participants with a severe open tibia fracture requiring multiple irrigation and debridement surgeries. Eligible participants will be randomized to receive either an antibiotic bead pouch or negative pressure wound therapy (NPWT) for their temporary open fracture wound management. Outcomes will be assessed at 6 weeks, 3 months, and 6 months post-surgery. The primary outcome will be a composite outcome to evaluate clinical status six months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) injury-related amputation of the lower extremity, 3) unplanned reoperation to manage wound complications, infection, or delayed fracture healing, and 4) clinical fracture healing as assessed using the Functional IndeX for Trauma (FIX-IT) instrument. The secondary outcomes will independently assess the four components of the primary outcome. This is a Phase III trial.

Description:

The primary objective of early open fracture management is to minimize the risk of complications. In severe cases, multiple irrigation and debridement surgeries are required to overcome the severe wound contamination, to reassess the evolving tissue injury, and/or to temporize and plan appropriate soft tissue coverage with a skin graft or muscle flap. When multiple irrigation and debridement surgeries are needed, there is uncertainty on how the open fracture wound should be managed between procedures. Negative pressure wound therapy (NPWT), commonly known as a Wound VAC, is the preferred method of open fracture wound management for most surgeons. Opponents of NPWT believe that NPWT desiccates the open fracture wound and rapidly removes any local antibiotics placed in the wound during surgery. Instead of using NPWT, they place temporary non-absorbable antibiotic-laden cement beads into the open fracture wound and seal it with a large occlusive dressing. This wound management strategy is known as an antibiotic cement bead pouch, or more commonly a Bead Pouch. Mounting evidence questions the effectiveness of NPWT to prevent open fracture complications. Additionally, emerging comparative studies suggest the antibiotic bead pouch may significantly reduce the risk of infection compared to NPWT. This trial seeks to fill this critical knowledge gap.

The primary objective of this trial is to determine if the antibiotic bead pouch, compared to NPWT application, is more effective at reducing open tibia fracture complications. The primary outcome will be a composite outcome to evaluate clinical status six months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) injury-related amputation of the lower extremity, 3) unplanned reoperation to manage wound complications, infection, or delayed fracture healing, and 4) clinical fracture healing as assessed using the Functional IndeX for Trauma (FIX-IT) instrument. The secondary objectives will independently assess the four components of the primary outcome.

The trial population includes patients 18 years and older with a severe open tibia fracture requiring more than one irrigation and debridement and being treated with internal or external fixation for definitive fracture management. Patients who have contraindications to the NPWT or local intrawound antibiotics will be excluded.

312 participants will be randomized in a 1:1 ratio to receive either an intraoperative antibiotic bead pouch or negative pressure wound therapy (NPWT). Participants will receive their allocated wound management strategy at the conclusion of their first irrigation and debridement procedure. Participants will have follow-up assessments at 6 weeks, 3 months and 6 months post-fracture.

The primary outcome will be a composite outcome to evaluate clinical status six months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) injury-related amputation of the lower extremity, 3) unplanned reoperation to manage wound complications, infection, or delayed fracture healing, and 4) clinical fracture healing as assessed using the Functional IndeX for Trauma (FIX-IT) instrument. The secondary outcomes will independently assess the four components of the primary outcome. An Adjudication Committee will review all primary and secondary endpoints and a Data Safety Monitoring Committee (DSMC) will review all safety events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 312
• Est. completion date: October 1, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

The inclusion criteria are:

1. Patients 18 years of age or older.

2. Severe open tibia fracture requiring more than one irrigation and debridement procedure to treat the open fracture.

3. Planned internal or external fixation for definitive fracture management.

4. 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.

The exclusion criteria are:

1. Due to the severity of injury, the treating surgeon does not believe limb salvage >6 months is likely to be successful based on the emergency department or initial intraoperative assessment (prior to enrolment and randomization).

2. Medical contraindication to antibiotic beads.

3. Medical or injury contraindication to NPWT. Injury contraindications could include situations in which the NPWT could not be placed over a vascular graft or exposed neurovascular structure.

4. Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic (as applicable).

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

6. Incarceration.

7. Women of child-bearing potential who are pregnant or intending to become pregnant within the next 6 months.

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

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

10. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.

11. Prior enrollment in the trial.

12. Other reason to exclude the patient, as approved by the Methods Center.

Related Conditions & MeSH terms

• Open tíbia Fracture
• Tibial Fractures

Intervention

Drug:
• Antibiotic Cement Bead Pouch
The antibiotic bead pouch provides an antibiotic delivery mechanism. It is made by combining polymethyl methacrylate (PMMA) cement with generic forms of vancomycin and tobramycin powder.

Device:
• Negative Pressure Wound Therapy
Standard application of negative pressure wound therapy

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	Royal Columbian Hospital	New Westminster	British Columbia
United States	University of Maryland, R Adams Cowley Shock Trauma Center	Baltimore	Maryland
United States	University of Cincinnati	Cincinnati	Ohio
United States	Inova Fairfax	Falls Church	Virginia
United States	University of Florida	Gainesville	Florida
United States	Prisma Health	Greenville	South Carolina
United States	Indiana University	Indianapolis	Indiana
United States	University of Maryland Capital Region Health	Largo	Maryland
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Bryan Medical Center	Lincoln	Nebraska
United States	University of Southern California	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Miami	Miami	Florida
United States	University of Utah	Salt Lake City	Utah
United States	University of Mississippi	University	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	McMaster University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical status	Clinical status is a hierarchal composite of the following outcomes: i) all-cause mortality ii) amputation at the fracture location iii) unplanned reoperation to manage wound complications, an infection, or promote fracture healing, iv) clinical fracture healing assessed using the Functional IndeX for Trauma (FIX-IT) instrument.	6 months
Secondary	Mortality	All-cause mortality	6 months
Secondary	Amputation	Injury-related amputation of the lower extremity	6 months
Secondary	Unplanned reoperation(s)	Unplanned reoperation to manage wound complications, an infection, or promote fracture healing.	6 months
Secondary	Clinical fracture healing	Clinical fracture healing assessed using the Functional IndeX for Trauma (FIX-IT) instrument.	6 months