A Randomized Controlled Trial Comparing Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy for the Management of Severe Open Tibia Fracture Wounds
Y
Yohan Jang
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
N/A
100 participants needed
1 Location
Brief description of study
What is this study about?
Open tibia fracture complications are debilitating for patients. NPWT is the current standard of care for temporary wound management of severe open fractures requiring multiple debridements. Emerging comparative studies suggest that the antibiotic bead pouch may significantly reduce the risk of open fracture infection and its related complications compared to NPWT. The primary objective is to determine if the antibiotic bead pouch, compared to NPWT application, is more effective at reducing open tibia fracture complications.
THIS STUDY IS ENROLLING BY INVITATION ONLY
THIS STUDY IS ENROLLING BY INVITATION ONLY - Patients with an open tibia fracture (OTA 41, 42, 43) will be screened for eligibility in the emergency room by research personnel, prior to going to the operating room for the first irrigation and debridement of the open fracture and wound. The final determination of eligibility will take place in the operating room when the surgeon determines if the patient will require subsequent irrigation and debridement procedures to manage the open injury. Patients with bilateral tibia fractures will be eligible for inclusion; however, only the most severe eligible fracture will be included, as determined by the attending surgeon.
Detailed description of study
What is involved in this study?
- Included patients will be randomized to receive either an intraoperative antibiotic bead pouch or NPWT.
- The timing of the trial interventions, other adjunctive treatments, and the fracture fixation procedures will be documented for both treatment groups.
- Participants will receive their allocated wound management strategy at the conclusion of their first irrigation and debridement, and they will continue to receive the same wound treatment until definitive wound closure is achieved at a subsequent surgery.
- Follow-up visits will occur at regularly scheduled clinic visits at 6 weeks, 3 months, and 6 months post-fracture.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Open tibia fracture
-
Age: 18 years - 100 years
-
Gender: All
Inclusion criteria
1. Patients 18 years of age and older
2. Severe open tibia fracture (OTA 41, 42, 43) 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.
2. Severe open tibia fracture (OTA 41, 42, 43) 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.
Exclusion criteria:
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, including previously known allergies or
sensitivities to vancomycin and/or tobramycin.
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 not using effective contraceptive
methods.
8. Currently enrolled in a trial 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.
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, including previously known allergies or
sensitivities to vancomycin and/or tobramycin.
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 not using effective contraceptive
methods.
8. Currently enrolled in a trial 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.
Updated on
08 Apr 2025.
Study ID: ORTHO-DOD-BVV, 19717
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