Open tíbia FracturePhase 3BeadsvsVacNCT05615844
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
A Phase 3 study testing Antibiotic Cement Bead Pouch and Negative Pressure Wound Therapy in people with Open tíbia Fracture, run by University of Maryland, Baltimore at 35 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open tíbia Fracture
- What is being tested?
- Antibiotic Cement Bead Pouch and Negative Pressure Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 35 sitesin 2 countries
- Study dates
- 5 Nov 2023to 1 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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:
- Patients 18 years of age or older.
- Severe open tibia fracture requiring more than one irrigation and debridement procedure to treat the open fracture.
- Planned internal or external fixation for definitive fracture management.
- Formal surgical debridement within 72 hours of their injury.
- Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
- Informed consent obtained.
The exclusion criteria are:
- 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).
- Medical contraindication to antibiotic beads, including previously known allergies or sensitivities to vancomycin and/or tobramycin.
- 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.
- Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic (as applicable).
- Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
- Incarceration.
- Women of child-bearing potential who are pregnant or intending to become pregnant within the next 6 months.
- Currently enrolled in a study that does not permit co-enrollment.
- Unable to obtain informed consent due to language barriers.
- Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
- Prior enrollment in the trial.
- Other reason to exclude the patient, as approved by the Methods Center.
Trial locations and contacts
35 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
35 sites in 2 countries
United States30 sites, 25 recruiting
- Recruiting
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
Heather Phipps, 410-706-2492
Mark Gage, MD
- Withdrawn
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
John Wixted, MD, (617) 667-3940, jwixted@bidmc.harvard.edu
- Recruiting
Dignity Health Chandler Regional Medical Center
Chandler, Arizona, 85224
William Naylor, DO, (480) 728-4470, william.naylor2@commonspirit.org
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
Michael Beltran, MD
- Recruiting
Bon Secours Mercy Health
Cincinnati, Ohio, 45237
John Gentile, MD, 330-480-3990, jgentile@mercy.com
- Recruiting
Prisma Health - Midlands
Columbia, South Carolina, 29203
Daniel Cunningham, MD, (803) 296-7846, daniel.cunningham2@prismahealth.org
- Recruiting
University of California, Davis
Davis, California, 95616
Augustine Saiz, MD, 800-282-3284, amsaiz@health.ucdavis.edu
- Recruiting
Slocum Center
Eugene, Oregon, 97401
Brandon Wilkinson, MD, 541-485-8111, brandon.wilkinson@slocumcenter.com
- Recruiting
Inova Fairfax
Falls Church, Virginia, 22042
Greg Gaski, MD
- Recruiting
Sanford Medical Center
Fargo, North Dakota, 58103
Michael White, MD, (701) 234-2000, Michael.white@sanfordhealth.org
- Recruiting
University of Florida
Gainesville, Florida, 32611
Jennifer Hagen, MD
- Recruiting
Prisma Health
Greenville, South Carolina, 29605
Kyle Jeray, MD
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Luke Lopas, MD, (317) 944-9400, llopas@iuhealth.org
- Recruiting
University of Florida Health Jacksonville
Jacksonville, Florida, 32207
Porter Young, MD, (904) 383-1010, Porter.Young@jax.ufl.edu
- Recruiting
University of Maryland Capital Region Health
Largo, Maryland, 20774
Brent Bauer, MD, 410-448-6400, bbauer@som.umaryland.edu
- Withdrawn
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Ida L Gitajn, MD
- Completed
Bryan Medical Center
Lincoln, Nebraska, 68506
- Recruiting
University of Southern California
Los Angeles, California, 90033
Joseph Patterson, MD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Carol Lin, MD, 310-423-9839, carol.lin@cshs.org
- Withdrawn
University of Wisconsin
Madison, Wisconsin, 53792
- Recruiting
University of Miami
Miami, Florida, 33146
Giselle Hernandez, MD, (305) 325-5511, g.hernandez@med.miami.edu
- Withdrawn
Yale University
New Haven, Connecticut, 06520
- Recruiting
University of California, Irvine
Orange, California, 92868
Gerard Slobogean, MD, 714-456-1699, gsloboge@hs.uci.edu
- Recruiting
Ortegon Health & Science University
Portland, Oregon, 97239
Zachary Working, MD
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Lucas Marchand, MD
- Recruiting
Sanford Health
Sioux Falls, South Dakota, 57104
Robert Van Demark III, MD, 605-333-1000, Rob.VanDemarkIII@SanfordHealth.org
- Recruiting
University of Arizona
Tucson, Arizona, 85721
Michael McKee, MD, 602-827-2905, michael.mckee@bannerhealth.com
- Recruiting
University of Mississippi
University, Mississippi, 38677
Patrick Bergin, MD
Canada5 sites, 5 recruiting
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
Jamal Al-Asiri, MD
- Recruiting
London Health Sciences Centre
London, Ontario, N6C 2R6
Emil Schemitsch, MD, (519) 663-3307, emil.schemitsch@lhsc.on.ca
- Recruiting
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
Darius Viskontas, MD
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
Steven Papp, MD, 613-798-5555 ext. 18131, spapp@toh.ca
- Recruiting
University of British Columbia
Vancouver, British Columbia, V5Z 1M9
David Stockton, MD, 604-875-5809, David.Stockton@vch.ca
About this study
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
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.
Read the detailed 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.
- Conditions
- Open tíbia Fracture
- Being tested
- Antibiotic Cement Bead Pouch, Negative Pressure Wound Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic Cement Bead PouchDrug
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.
Negative Pressure Wound TherapyDevice
Standard application of negative pressure wound therapy
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic Cement Bead Pouch | Experimental | The antibiotic cement bead pouch involves placing temporary non-absorbable antibiotic-laden cement beads into the open fracture wound and sealing the wound with a large occlusive dressing for prophylaxis against bacteria.
The antibiotic beads used will be prepared intraoperatively by the surgical team. The bead recipe will be comprised of a ratio of 2 grams of vancomycin, 2.4 grams of tobramycin, and 40g (one bag) of PMMA cement. The beads will be handmade and approximately 10-mm in diameter. The number of beads placed in the wound will be at the discretion of the treating surgeon based on recipient wound size. As commonly practiced, the antibiotic beads may be exchanged for new beads at each subsequent irrigation and debridement surgery. The number of beads, the number of replaced beads, and the removal of the antibiotic beads will be recorded. Receives: Drug: Antibiotic Cement Bead Pouch |
| Negative Pressure Wound Therapy (NPWT) | Active comparator | The NPWT system is a sealed dressing placed over the open fracture wound that includes an occlusive plastic wound dressing connected to a vacuum pump, tubing, and a canister to collect fluid. The pump creates a vacuum seal and exerts negative pressure on the wound to remove fluid and maintain a sealed environment. NPWT promotes wound healing through four primary mechanisms: 1) wound shrinkage or macrodeformation; 2) microdeformation at the foam-wound surface interface; 3) fluid removal; and 4) stabilization of the wound environment.
125 mmHg continuous negative pressure is the recommended NPWT device setting; however, the treating surgeon will be allowed to adjust these settings as clinically necessary.
The frequency and timing of NPWT changes will also be at the surgeon's discretion but is expected to primarily coincide with the timing of repeat debridement, typically every 24-72 hours until definitive management has occurred. Receives: Device: Negative Pressure Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical status
Clinical status is a hierarchal composite of the following outcomes:
- 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.
Measured: 6 months
Secondary outcomes (4)
Mortality
All-cause mortality
Measured: 6 months
Amputation
Injury-related amputation of the lower extremity
Measured: 6 months
Unplanned reoperation(s)
Unplanned reoperation to manage wound complications, an infection, or promote fracture healing.
Measured: 6 months
Clinical fracture healing
Clinical fracture healing assessed using the Functional IndeX for Trauma (FIX-IT) instrument.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start5 Nov 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open tíbia FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, University of California, Irvine
- Responsible party
- Principal investigator, Mark Gage, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615844
- Sponsor's protocol ID
- SSU00222774
- Acronym
- BeadsvsVac
- Status last verified
- Feb 2026
- First submitted
- 14 Oct 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Marchand LS, Slobogean G, O'Hara NN, Harris AD, Grainger DW, Thabane L, Bhandari M, Della Rocca GJ, Kellam PJ, Zura RD, Marvel D, Wells JL, Gitajn IL, Jeray KJ, O'Toole RV, Working ZM, Natoli RM, Bergin PF, Hagen JE, Levack AE, Guerra-Farfan E, Schrank GM, Hebden JN, Mossuto F, Tsoutsounakis C, Pogorzelski D, Pineda H, Bzovsky S, Sprague S; BvV Investigators. Randomised controlled trial comparing antibiotic cement bead pouch versus negative pressure wound therapy for the management of severe open tibia fracture wounds: Beads versus VAC (BvV) protocol. BMJ Open. 2026 May 4;16(5):e088521. doi: 10.1136/bmjopen-2024-088521.
PubMed 42082225
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05615844
- Acronym / sponsor ID
- BeadsvsVac / SSU00222774
- Conditions
- Open tíbia Fracture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- McMaster University, University of California, Irvine
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic Cement Bead Pouch | Experimental | Drug: Antibiotic Cement Bead PouchThe antibiotic cement bead pouch involves placing temporary non-absorbable antibiotic-laden cement beads into the open fracture wound and sealing the wound with a large occlusive dressing for prophylaxis against bacteria. The antibiotic beads used will be prepared intraoperatively by the surgical team. The bead recipe will be comprised of a ratio of 2 grams of vancomycin, 2.4 grams of tobramycin, and 40g (one bag) of PMMA cement. The beads will be handmade and approximately 10-mm in diameter. The number of beads placed in the wound will be at the discretion of the treating surgeon based on recipient wound size. As commonly practiced, the antibiotic beads may be exchanged for new beads at each subsequent irrigation and debridement surgery. The number of beads, the number of replaced beads, and the removal of the antibiotic beads will be recorded. |
| Negative Pressure Wound Therapy (NPWT) | Active comparator | Device: Negative Pressure Wound TherapyThe NPWT system is a sealed dressing placed over the open fracture wound that includes an occlusive plastic wound dressing connected to a vacuum pump, tubing, and a canister to collect fluid. The pump creates a vacuum seal and exerts negative pressure on the wound to remove fluid and maintain a sealed environment. NPWT promotes wound healing through four primary mechanisms: 1) wound shrinkage or macrodeformation; 2) microdeformation at the foam-wound surface interface; 3) fluid removal; and 4) stabilization of the wound environment. 125 mmHg continuous negative pressure is the recommended NPWT device setting; however, the treating surgeon will be allowed to adjust these settings as clinically necessary. The frequency and timing of NPWT changes will also be at the surgeon's discretion but is expected to primarily coincide with the timing of repeat debridement, typically every 24-72 hours until definitive management has occurred. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic Cement Bead PouchThe 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. | Drug | Antibiotic Cement Bead Pouch |
| Negative Pressure Wound TherapyStandard application of negative pressure wound therapy | Device | Negative Pressure Wound Therapy (NPWT) |
Primary outcome
Clinical status
Time frame: 6 months
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.
4 secondary outcomes
Mortality
Time frame: 6 months
Amputation
Time frame: 6 months
Unplanned reoperation(s)
Time frame: 6 months
Clinical fracture healing
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Derived from this study: PubMed 42082225Marchand LS, Slobogean G, O'Hara NN, Harris AD, Grainger DW, Thabane L, Bhandari M, Della Rocca GJ, Kellam PJ, Zura RD, Marvel D, Wells JL, Gitajn IL, Jeray KJ, O'Toole RV, Working ZM, Natoli RM, Bergin PF, Hagen JE, Levack AE, Guerra-Farfan E, Schrank GM, Hebden JN, Mossuto F, Tsoutsounakis C, Pogorzelski D, Pineda H, Bzovsky S, Sprague S; BvV Investigators. Randomised controlled trial comparing antibiotic cement bead pouch versus negative pressure wound therapy for the management of severe open tibia fracture wounds: Beads versus VAC (BvV) protocol. BMJ Open. 2026 May 4;16(5):e088521. doi: 10.1136/bmjopen-2024-088521.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
35 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antibiotic Cement Bead Pouch and Negative Pressure Wound Therapy in people with Open tíbia Fracture, run by University of Maryland, Baltimore at 35 sites in 2 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Phipps, MPS (410-706-2492, hphipps@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical status (time frame: 6 months). 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 NCT05615844, which also lists 1 linked publication.
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 22 Oct 2026.