Post Operative Surgical Site InfectionPhase 3VANCONCT02227446
Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter Randomized, Controlled Trial (VANCO)
A Phase 3 study testing Vancomycin antibiotic powder in people with Post Operative Surgical Site Infection, run by Major Extremity Trauma Research Consortium at 1 site in United States.
Trial summary
The Vancomycin Study is a multi-center, prospective randomized controlled trial that will compare the proportion of deep surgical site infections within 6 months in patients treated with local Vancomycin powder compared to those treated without local Vancomycin powder at the time of fracture fixation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Operative Surgical Site Infection
- What is being tested?
- Vancomycin antibiotic powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,036 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Nov 2019
- Phase
- Phase 3
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All "high energy" tibial plateau fractures treated operatively with plate and screw fixation.
- We define "high energy" tibial plateau fractures as patients who are either:
- Initially treated with an external fixation (with or without limited internal fixation) and treated definitively more than 3 days later after swelling has resolved.
- Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment.
- Any tibial plateau fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds.
- All "high energy" pilon (distal tibial plafond) fractures treated operatively with plate and screw fixation. We define "high energy" pilon fractures as patients who are either:
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- Initially treated with an external fixation (with or without fibula fixation or limited internal fixation) and treated definitively more than 3 days later after swelling has resolved.
- Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment.
- Any tibial pilon fracture associated with ipsilateral leg compartment syndrome fasciotomy wounds.
- Ages 18 to 80 years
- Patients may have co-existing non-tibial infection, with or without antibiotic treatment.
- Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
- Patients may have a head injury
- Patients may have a portion of the fixation (e.g. fibula fixation in pilon or percutaneous screws across a tibial plateau fracture) prior to definitive plate fixation, at the initial surgery before randomization.
- Patients may have other orthopedic and non-orthopaedic injuries.
- Patients may have pre-existing musculoskeletal injuries, be non ambulators, or have spinal cord injuries.
- Women and minorities are included
Who cannot join
- The study injury: tibial plateau, pilon, is already infected at time of study enrollment.
- Patient speaks neither English nor Spanish.
- Patients who have already had definitive fixation prior to enrollment in the study.
- Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury or those how are intellectually challenged without adequate family support).
- Patients with allergies, drug administration reactions, or other sensitivities to Vancomycin (such as a history of Redman's Syndrome).
- Pregnancy.
- The study injury is a type IIIB or IIIC open fracture.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
About this study
Official title: Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter Randomized, Controlled Trial (Vancomycin Study)
The Vancomycin Study is a multi-center, prospective randomized controlled trial that will compare the proportion of deep surgical site infections within 6 months in patients treated with local Vancomycin powder compared to those treated without local Vancomycin powder at the time of fracture fixation.
Read the detailed description
Primary Aim: Compare the proportion of deep surgical site infections within 6 months in patients treated with local Vancomycin powder compared to those treated without local Vancomycin powder.
Primary Hypothesis: The proportion of deep surgical site infections will be lower for patients treated with local Vancomycin powder.
Secondary Aim #1: Compare antibiotic sensitivities of the bacteria in the patients who develop deep surgical site infections in study patients treated with local Vancomycin powder compared to those treated without local Vancomycin powder.
Hypothesis 1: In the patients who develop infections, the antibiotic sensitivity profiles between patients treated with local Vancomycin powder will be non-inferior to those treated without local Vancomycin powder.
Secondary Aim #2: Build and validate a risk prediction model for the development of deep surgical site infections in patients treated without local Vancomycin powder. (b) Explore whether the effect of local Vancomycin powder is modified by the predicted risk of infection.
Hypothesis 2: Patient (e.g. medical co-morbidities) and injury (e.g open fractures) factors will be highly predictive of infection risk.
Hypothesis 3: Patients with higher predictive risk will experience greater benefit from local antibiotics.
- Conditions
- Post Operative Surgical Site Infection
- Being tested
- Vancomycin antibiotic powder
- Keywords
- Surgical site infection risk prevention, Bacterial species type and antibacterial sensitives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin antibiotic powderDrug
At the time of fracture fixation 1000 mg of Vancomycin powder placed into the wound during wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin Antibotic Powder | Experimental | Participants in the treatment group will receive the study intervention of a maximum dose of 1000mg of Vancomycin antibiotic powder in their wound bed, which is placed right before wound closure. Vancomycin antibiotic powder may be combined with normal saline as per clinical practice at the participating institution.
In addition, participants in this group will receive standard of care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection. Receives: Drug: Vancomycin antibiotic powder |
| Standard of Care | No intervention | Participants in this group will receive standard of care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection. Participants in this group will not receive local Vancomycin antibiotic powder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Clinically Significant Deep Surgical Site Infection (SSI)
The main outcome will be the presence of clinically significant surgical site infection (SSI) in the first 26 weeks after surgery, as determined by CDC guidelines. The CDC criteria is currently 3 months for surgical site infection. To help capture more infections the study investigators have moved the time frame back to 6 months.
Wound characteristics will also be evaluated using the ASEPSIS score. In this system wounds are scored using the weighted sum of points assigned for predetermined criteria including the need for Additional treatment, presence of Serous drainage, Erythema, Purulent exudates, Separation of deep tissues, the Isolation of bacteria, and the duration of patients Stay (ASEPSIS).
The study investigators will define deep infections as those that require operative treatment, and superficial infections as those that are treated without operative intervention.
Measured: 26 weeks
Secondary outcomes (2)
Pathogen Type
This secondary outcome represents the type of bacteria or fungus isolated from the fracture site at the time of surgery for infection during the follow up period. Cultures were obtained using routine clinical sterile technique in the operating room and processed according to standard laboratory practices at each participating site. An infectious disease physician blinded to treatment arm reviewed and categorized all culture results. Pathogens were classified into five groups: gram-positive cocci, gram-positive rods, gram-negative rods, anaerobes, and fungi. The frequency of each pathogen type recovered was compared between patients who received topical vancomycin powder during surgery and those who did not.
Measured: 26 weeks
Bacterial Susceptibility and Antimicrobial Resistance
This secondary outcome characterizes the susceptibility of recovered pathogens to commonly used antibiotics collected at the time of surgery for infection during follow up. Antimicrobial susceptibility testing was performed by hospital laboratories using standard methods at each participating site. The pattern of susceptibility and resistance to various antimicrobial agents was compared between the two treatment groups to assess whether exposure to topical vancomycin powder was associated with differences in antibiotic resistance profiles, including the emergence of resistant organisms or other hard-to-treat pathogens.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2018
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Operative Surgical Site InfectionStudies 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
- 1,036 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renan Castillo, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public HealthRobert O'Toole, MD, Principal investigator, University of Maryland R Adams Cowley Shock Trauma CenterAnthony Carlini, MS, Study director, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227446
- Sponsor's protocol ID
- W81XWH-10-2-0134
- Acronym
- VANCO
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2014
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Major Extremity Trauma Research Consortium (METRC); O'Toole RV, O'Hara NN, Carlini AR, Schrank GM, Chung S, Gary JL, Obremskey W, Matuszewski PE, Teague D, Natoli RM, Gitajn IL, Weaver MJ, Renninger CH, Levack AE, Degani Y, Collins SC, Weston-Farber E, Howe AL, Thompson RE, Castillo RC, Karunakar MA, Blum L, Harmer L, Hsu JR, Kempton LB, Phelps KD, Seymour RB, Sims SH, Acharya MS, Callahan H, Chavez-Araujo LM, Churchill C, Gambuzza MP, Haim KR, Ishman E, Kendall JS, Mullis ND, Young C, Pilson HT, Carroll EA, Goodman JB, Holden MB, Jones AL, Moon C, Lin CA, Marecek GS, Moffitt GB, Conlan T, George AV, Fisher LA, Mullin DS, Recendez CL, Aneja A, Brameier DT, Heng M, Ly TV, Stenquist DS, Suneja N, Wignakumar T, Borgida JS, Policicchio TJ, Hanson GR, Alese OM, Ricci WM, Behrens SB, Dvorzhinskiy A, Bilodeau RE, Klinger CE, Mullis BH, Jang Y, Lopas LA, McKinley TO, O'Neill DC, Szatkowski JP, Virkus WW, Hill LC, Gaski G, Hymes RA, Ahn J, Goch AM, Holzman M, Malekzadeh AS, Schulman JE, Rivera JC, Krause PC, Bridgman C, Cohen J, Eikani C, Chavez M, Kudulis M, Warner SJ, Achor TS, Choo A, Eastman JG, Kellam PJ, Boutte SJ, Guevara KD, Reid KR, Vallier HA, Tucci AV, Davis JM, Bell AC, Bonyun ME, Healey K, Li V, McKibben NS, Nascone J, Okhuereigbe D, Sciadini MF, Slobogean G, Zingas N, Kovvur M, Lawrence JE, Phipps H, Rudnicki J, Turner KE, Hayda R, Evans AR, Quinnan S, Benitez A, Rehman S, Soderquist MC, Townsend CB, Caroom C, Collins AC, Okwumabua E, Shaikh HS, Spitler CA, Agarwal A, Johnson MD, Haller JM, Marchand LS, Alfonso NA, Gorman MA, Charlton WM, Scott BR, Kraus KM, Meredith SJ, Talwar S, Bergin PF, Jha AJ, McGee S, Nehete PV, Pryor TA, Spears I, Chen AT, Kelley B, Nez NR, Ertl WJ, Hull BR, Blumenthal S, Patterson JT, Flynn C, Ross RC, Agarwal A, Weiss DB, Hadeed MM, Yarboro SR, Daoud T, McVey ED, Whiting PS, Domes C, Goodspeed DC, Kuhn GR, Boyce R, Libos A, Mitchell PM, Moreno-Diaz AF, Ponce RB, Stinner DJ, Tatman LM, Velasco-Castro J, Trochez K, Satpathy J, Zuelzer DA, Potter BK. Intrawound Tobramycin Plus Vancomycin to Prevent Surgical Site Infection in Tibial Fractures: The TOBRA Randomized Clinical Trial. JAMA. 2026 May 12;335(18):1586-1595. doi: 10.1001/jama.2026.4023.
PubMed 41984450Major Extremity Trauma Research Consortium (METRC); O'Toole RV, Joshi M, Carlini AR, Murray CK, Allen LE, Huang Y, Scharfstein DO, O'Hara NN, Gary JL, Bosse MJ, Castillo RC, Bishop JA, Weaver MJ, Firoozabadi R, Hsu JR, Karunakar MA, Seymour RB, Sims SH, Churchill C, Brennan ML, Gonzales G, Reilly RM, Zura RD, Howes CR, Mir HR, Wagstrom EA, Westberg J, Gaski GE, Kempton LB, Natoli RM, Sorkin AT, Virkus WW, Hill LC, Hymes RA, Holzman M, Malekzadeh AS, Schulman JE, Ramsey L, Cuff JAN, Haaser S, Osgood GM, Shafiq B, Laljani V, Lee OC, Krause PC, Rowe CJ, Hilliard CL, Morandi MM, Mullins A, Achor TS, Choo AM, Munz JW, Boutte SJ, Vallier HA, Breslin MA, Frisch HM, Kaufman AM, Large TM, LeCroy CM, Riggsbee C, Smith CS, Crickard CV, Phieffer LS, Sheridan E, Jones CB, Sietsema DL, Reid JS, Ringenbach K, Hayda R, Evans AR, Crisco MJ, Rivera JC, Osborn PM, Kimmel J, Stawicki SP, Nwachuku CO, Wojda TR, Rehman S, Donnelly JM, Caroom C, Jenkins MD, Boulton CL, Costales TG, LeBrun CT, Manson TT, Mascarenhas DC, Nascone JW, Pollak AN, Sciadini MF, Slobogean GP, Berger PZ, Connelly DW, Degani Y, Howe AL, Marinos DP, Montalvo RN, Reahl GB, Schoonover CD, Schroder LK, Vang S, Bergin PF, Graves ML, Russell GV, Spitler CA, Hydrick JM, Teague D, Ertl W, Hickerson LE, Moloney GB, Weinlein JC, Zelle BA, Agarwal A, Karia RA, Sathy AK, Au B, Maroto M, Sanders D, Higgins TF, Haller JM, Rothberg DL, Weiss DB, Yarboro SR, McVey ED, Lester-Ballard V, Goodspeed D, Lang GJ, Whiting PS, Siy AB, Obremskey WT, Jahangir AA, Attum B, Burgos EJ, Molina CS, Rodriguez-Buitrago A, Gajari V, Trochez KM, Halvorson JJ, Miller AN, Goodman JB, Holden MB, McAndrew CM, Gardner MJ, Ricci WM, Spraggs-Hughes A, Collins SC, Taylor TJ, Zadnik M. Effect of Intrawound Vancomycin Powder in Operatively Treated High-risk Tibia Fractures: A Randomized Clinical Trial. JAMA Surg. 2021 May 1;156(5):e207259. doi: 10.1001/jamasurg.2020.7259. Epub 2021 May 12.
PubMed 33760010