Post Operative Surgical Site InfectionPhase 3SEXTANT 2NCT04678154
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2
A Phase 3 study testing Vancomycin and Tobramycin in people with Post Operative Surgical Site Infection, run by Major Extremity Trauma Research Consortium at 31 sites in United States.
Trial summary
The PRCT evaluates infection outcomes as well as fracture and antibiotic-related complications to include the emergence of resistant bacteria associated with two different antibiotic strategies in the treatment of Gustilo type IIIB tibia and hindfoot fractures (calcaneus and talus) and selected IIIA fractures of the… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Post Operative Surgical Site Infection
- What is being tested?
- Vancomycin and Tobramycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 31 sitesUnited States
- Study dates
- 7 May 2021to 31 Mar 2029
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Injury meeting at least one of the following criteria:
- Gustilo type III fractures of the tibia (OTA 41 plateau, OTA 42 shaft and OTA 43 pilon); ankle (OTA 44); calcaneus (OTA 82) and/or talus (OTA 81) with injury characteristics meeting at least one of the following criteria: i. All IIIB fractures ii. IIIA fractures that require a planned second debridement prior to definitive closure / coverage iii. IIIA fractures with extensive contamination or muscle damage precluding definitive internal fixation at the time of initial surgery iv. IIIA fractures with extensive degloving or wound greater than 10 cm after debridement (if indicated, primary wound closure is allowed. Primary wound closure refers to the definitive closure of the wound at the initial surgical event, without plans for re-entry for additional debridement and/or fracture fixation) v. IIIA fractures severe fracture comminution resulting from high energy trauma (if indicated, primary wound closure/coverage is allowed) vi. IIIA fractures with AO/OTA OFC contamination level of severe with material imbedded into bone or soft tissue or with a severe high risk environmental contamination from farm, fecal, dirty water inoculation or other equivalent (if indicated, primary wound closure/coverage is allowed) vii. IIIA Fractures where the skin could be closed after extensive muscle or bone removal (if indicated, primary wound closure/coverage is allowed) viii. IIIA fractures with bone loss resulting in a circumferential gap of 1 cm after debridement (if indicated, primary wound closure/coverage is allowed) ix. Fractures where fasciotomies were performed for impending or diagnosed compartment syndromes (regardless of the initial open or closed classification of the fracture x. Traumatic "zone-of-injury" trans-tibial amputations requiring DPC, and/or flap coverage
- Ages 18 - 64 years inclusive
- Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
- Patients may have a traumatic brain injury.
- Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur, or foot injuries.
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- Patients may be treated initially at an outside institution prior to transferring to the study institution, as long as the definitive wound closure/coverage was not performed prior to entrance into the study.
- Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as "more severe" by the treating surgeon will be enrolled in the study.
- Patients may have co-existing non-tibial or hindfoot infections, with or without antibiotic treatment.
- Patients may be definitively stabilized using any method (nail, plate, ex fix, or cast).
- Patients may have fasciotomy.
Who cannot join
- Patient speaks neither English or Spanish
- Patient in current therapy for a wound, implant or fracture site infection related to the study site.
- Patient is pregnant, potentially pregnant, or lactating.
- Patient likely to have difficulty maintaining follow-up, including:
- Diagnosis of a severe psychiatric condition
- Intellectually challenged without adequate family support
Show all 10Show fewer
- Resides outside of the hospital's catchment area, unless willing to follow-up by phone or telemedicine
- Planning to follow-up at another medical center, unless willing to follow-up by phone or telemedicine
- Being a prisoner
- Not having a means of contact (address, cell phone, home phone, e-mail)
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
United States31 sites, 31 recruiting
- Recruiting
Emory University School of Medicine
Atlanta, Georgia, 30303
William Reisman, MD
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Fahim Choudhury, (303) 724-3185, fahim.choudhury@cuanschutz.edu
- Recruiting
University of Maryland , MD Department of Orthopaedics
Baltimore, Maryland, 21201
Yasmin Degani, MPH, ydegani@som.umaryland.edu
Robert O'Toole, MD
- Recruiting
Walter Reed Military Medical Center
Bethesda, Maryland, 20889
Heather Decot, (301) 295-4568, heather.k.decot.ctr@health.mil
- Recruiting
Harvard/Mass General/Brigham Hospitals
Boston, Massachusetts, 02115
Thiru Wignakumar, twignakumar@bwh.harvard.edu
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Nevaeh Nez, nevaeh_nez@med.unc.edu
- Recruiting
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
Christine Churchill
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Eric McVey, 434.243.5382, EDM9U@hscmail.mcc.virginia.edu
David Weiss, MD
- Recruiting
METROHealth
Cleveland, Ohio, 44109
Anna Vergon, 216-778-3656, avergon@metrohealth.org
- Recruiting
Ohio State University Wexner Medical Center
Columbus, Ohio, 43201
Jessica Wiseman, 614-293-2064, jessica.wiseman@osumc.edu
- Recruiting
Inova Fairfax MEdical Campus
Falls Church, Virginia, 22042
Senay Ghidei, (703) 526-4382, Senay.Ghidei@Inova.org
- Recruiting
University of Texas Health Science Center - Houston
Houston, Texas, 77030
Sterling Boutte, Sterling.Boutte@uth.tmc.edu
Stephen Warner, MD
- Recruiting
Indiana University School of Medicine - Methodist Hospital
Indianapolis, Indiana, 46202
Maricella Diaz, 317.963.5034, diaz4@iu.edu
- Recruiting
Indiana University/Eskenazi Health
Indianapolis, Indiana, 46202
Molly Moore, 317-880-3581, momfreed@iupui.edu
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Sandra Powe, 601-815-1045, spowe@umc.edu
- Recruiting
Jamaica Hospital Medical Center
Jamaica, New York, 11418
Sanjit Konda, MD
- Recruiting
Dartmouth Hitchcock
Lebanon, New Hampshire, 03766
Devin Mullin, devin.s.mullin@hitchcock.org
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Matthew Eubank, (859)562-3428, mseuba01@uky.edu
- Recruiting
Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota, 55415
Andrew Schmidt, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Karen Trochez, karen.m.trochez@Vanderbilt.Edu
William T. Obremskey, MD
- Recruiting
LSU Health Sciences
New Orleans, Louisiana, 70112
Jessica Rivera, jrive5@lsuhsc.edu
- Recruiting
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73104
Lyndee Nguyen, 405-271-4426, lyndee-nguyen@ouhsc.edu
- Recruiting
Temple University
Philadelphia, Pennsylvania, 19140
Adam Lloyd-Jones, 267-643-5067, adam.lloyd-jones@temple.edu
- Recruiting
Brown University/Rhode Island Hospital
Providence, Rhode Island, 02905
Roman Hayda, MD
- Recruiting
Rhode Island Hospital/Brown University
Providence, Rhode Island, 02905
MJ Crisco, 401-457-2189, mjcrisco@uoi.com
- Recruiting
Stanford University
Redwood City, California, 94063
Carina Tedesco, 650-723-8386, ctedesco@stanford.edu
- Recruiting
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
Caleb Bridgman, 804.628.3584, Caleb.Bridgwater@vcuhealth.org
- Recruiting
_University of California, San Francisco
San Francisco, California, 94110
Eleni Berhaneselase, 415-476-2124, eleni.berhaneselase@ucsf.edu
- Recruiting
University of California at San Francisco
San Francisco, California, 94110
Eleni Berhaneselase, Eleni.Berhaneselase@ucsf.edu
Saam Morshed, MD
- Recruiting
St Mary's University/Tenent Health
West Palm Beach, Florida, 33407
Tracy Rodriguez, 561-882-6386, tracy.rodriguez@tenethealth.com
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Martha Holden, 336.716.5457, mholden@wakehealth.edu
About this study
Official title: Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2 - A Continuation of the Multicenter Randomized Control Trial SEXTANT 1
The PRCT evaluates infection outcomes as well as fracture and antibiotic-related complications to include the emergence of resistant bacteria associated with two different antibiotic strategies in the treatment of Gustilo type IIIB tibia and hindfoot fractures (calcaneus and talus) and selected IIIA fractures of the tibia and trauma-related transtibial amputations that are performed in the "zone-of-injury". This study will be conducted in established METRC level 1 trauma centers.
The patients will be randomized as close to admission as possible to either 1) Standard of Care (SOC) prophylactic open fracture protocol, including the use of topical antibiotic as per the usual practice of the surgeon or 2) experimental protocol (SEXTANT). The SEXTANT protocol includes application of wound bioburden-targeted topical Vancomycin powder and Tobramycin powder antibiotic treatment at the time of final wound closure/coverage combined with 72 hours of systemic antibiotic coverage targeted to both gram-positive and gram-negative pathogens. The study will compare the results of the current SOC prophylactic coverage to the strategic wound bioburden treatment (SEXTANT) protocol.
Read more
Up until the time of definitive wound closure/coverage, all patients will be treated per the usual regimen of the surgeon / center and in accordance with current Trauma Quality Improvement Program (TQIP) and Surgical Quality Improvement Program (SQIP) recommendations for the care of open fractures.14,15,17 It includes the administration of systemic antibiotics as close to the time of injury as possible.
In the definitive wound closure/coverage procedure post-operative period, participants in the intervention arm will receive 72 hours of systemic antibiotic therapy targeted at the modern wound bioburden, and patients in the usual care arm will receive post-operative care per the usual practice of their surgeon. All other activities related to follow-up and related treatments will proceed per the usual practice of the surgeon.
Read the detailed description
Specific Aim 1: To determine if the SEXTANT treatment strategy designed to address the modern wound bioburden at the time of delayed wound closure/coverage is superior to the standard-of-care (SOC) antibiotic protocol. Our primary comparison will be the proportion of fracture-related infections (FRI) under the SEXTANT arm versus the FRI proportion for those under standard of care in the first 180 days following final wound closure/coverage. One-year rates of FRI will also be assessed.
Secondary Aims:
To compare rates of antibiotic-related complications (including aseptic nonunion) and serious adverse events (SAEs), including emergence of antibiotic-resistant pathogens, of the two treatment groups in the first 180 days following final wound closure/coverage. One-year rates will also be assessed.
To compare the terminal bioburden of the wounds at the time of delayed closure/coverage as sampled by standard tissue microbiology and assess the effectiveness of the antibiotic regimen.
(Exploratory) To employ emerging NextGen Sequencing rapid PCR platforms for wound pathogen identification in a sub-cohort of patients.
- Conditions
- Post Operative Surgical Site Infection
- Being tested
- Standard of care, Vancomycin and Tobramycin
- Keywords
- Surgical site infection risk prevention, Bacterial species type and antibacterial sensitivities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careDrug
Participants in the control group will receive standard care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection. Topical antibiotics are allowed, if SOC for the institution, but are not mandated.
Vancomycin and TobramycinDrug
The patients in the SEXTANT cohort will receive 72 hours of targeted systemic antibiotic therapy (Table 2) and will have 1000 mg of Vancomycin and 1200 mg of Tobramycin administered to the wound surface, fracture site, and exposed hardware (if any) just prior to suture closure of the wound or flap.
72-hour of systemic gram-positive and gram-negative antibiotic coverage to target the terminal wound bioburden. The antibiotics coverage proposed as the primary choice includes PO Ciprofloxacin + PO linezolid or IV Ciprofloxacin and IV Vancomycin.
The preferred antibiotic regimen will be decided by study's ID team, in cooperation with the ID and Antibiotic Stewardship teams at each site. Antibiotic recommendations will be adjusted, if needed, to account for a Site's bacteria susceptibility / resistance profile, or the specific needs of an individual patient.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants in the control group will receive standard care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection. Topical antibiotics are allowed, if SOC for the institution, but are not mandated. Receives: Drug: Standard of care |
| Treatment | Experimental | The patients in the SEXTANT cohort will receive 72 hours of targeted systemic antibiotic therapy (Table 2) and will have 1000 mg of Vancomycin and 1200 mg of Tobramycin administered to the wound surface, fracture site, and exposed hardware (if any) just prior to suture closure of the wound or flap. Receives: Drug: Vancomycin and Tobramycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep surgical site infection
To determine if the SEXTANT treatment strategy designed to address the modern wound bioburden at the time of delayed wound closure/coverage is superior to the standard-of-care (SOC) antibiotic protocol. Our primary comparison will be the proportion of fracture-related infections (FRI) under the SEXTANT arm versus the FRI proportion for those under standard of care in the first 180 days following final wound closure/coverage. One-year rates of FRI will also be assessed.
Measured: 180 days from final wound closure/cloverage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start7 May 2021
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Micahel J Bosse, MD, Principal investigator, Carolinas Medical CenterRachel Seymour, PhD, Principal investigator, Atrium Health Musculoskeletal Institute ResearchRenan C Castillo, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public HealthAnthony R Carlini, MS, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678154
- Sponsor's protocol ID
- H294252510976
- Acronym
- SEXTANT 2
- Status last verified
- Jun 2026
- First submitted
- 11 Dec 2020
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2 - A Continuation of the Multicenter Randomized Control Trial SEXTANT 1
- ClinicalTrials.gov ID
- NCT04678154
- Acronym / sponsor ID
- SEXTANT 2 / H294252510976
- Conditions
- Post Operative Surgical Site Infection
- Keywords
- Surgical site infection risk prevention, Bacterial species type and antibacterial sensitivities
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 7 May 2021 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 21 Dec 2020 (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 PRCT evaluates infection outcomes as well as fracture and antibiotic-related complications to include the emergence of resistant bacteria associated with two different antibiotic strategies in the treatment of Gustilo type IIIB tibia and hindfoot fractures (calcaneus and talus) and selected IIIA fractures of the tibia and trauma-related transtibial amputations that are performed in the "zone-of-injury". This study will be conducted in established METRC level 1 trauma centers.
The patients will be randomized as close to admission as possible to either 1) Standard of Care (SOC) prophylactic open fracture protocol, including the use of topical antibiotic as per the usual practice of the surgeon or 2) experimental protocol (SEXTANT). The SEXTANT protocol includes application of wound bioburden-targeted topical Vancomycin powder and Tobramycin powder antibiotic treatment at the time of final wound closure/coverage combined with 72 hours of systemic antibiotic coverage targeted to both gram-positive and gram-negative pathogens. The study will compare the results of the current SOC prophylactic coverage to the strategic wound bioburden treatment (SEXTANT) protocol.
Up until the time of definitive wound closure/coverage, all patients will be treated per the usual regimen of the surgeon / center and in accordance with current Trauma Quality Improvement Program (TQIP) and Surgical Quality Improvement Program (SQIP) recommendations for the care of open fractures.14,15,17 It includes the administration of systemic antibiotics as close to the time of injury as possible.
In the definitive wound closure/coverage procedure post-operative period, participants in the intervention arm will receive 72 hours of systemic antibiotic therapy targeted at the modern wound bioburden, and patients in the usual care arm will receive post-operative care per the usual practice of their surgeon. All other activities related to follow-up and related treatments will proceed per the usual practice of the surgeon.
Detailed description
Specific Aim 1: To determine if the SEXTANT treatment strategy designed to address the modern wound bioburden at the time of delayed wound closure/coverage is superior to the standard-of-care (SOC) antibiotic protocol. Our primary comparison will be the proportion of fracture-related infections (FRI) under the SEXTANT arm versus the FRI proportion for those under standard of care in the first 180 days following final wound closure/coverage. One-year rates of FRI will also be assessed.
Secondary Aims:
To compare rates of antibiotic-related complications (including aseptic nonunion) and serious adverse events (SAEs), including emergence of antibiotic-resistant pathogens, of the two treatment groups in the first 180 days following final wound closure/coverage. One-year rates will also be assessed.
To compare the terminal bioburden of the wounds at the time of delayed closure/coverage as sampled by standard tissue microbiology and assess the effectiveness of the antibiotic regimen.
(Exploratory) To employ emerging NextGen Sequencing rapid PCR platforms for wound pathogen identification in a sub-cohort of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Standard of careParticipants in the control group will receive standard care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection. Topical antibiotics are allowed, if SOC for the institution, but are not mandated. |
| Treatment | Experimental | Drug: Vancomycin and TobramycinThe patients in the SEXTANT cohort will receive 72 hours of targeted systemic antibiotic therapy (Table 2) and will have 1000 mg of Vancomycin and 1200 mg of Tobramycin administered to the wound surface, fracture site, and exposed hardware (if any) just prior to suture closure of the wound or flap. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Injury meeting at least one of the following criteria:
- Ages 18 - 64 years inclusive
- Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
- Patients may have a traumatic brain injury.
- Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur, or foot injuries.
Key exclusion criteria (10 listed)
- Patient speaks neither English or Spanish
- Patient in current therapy for a wound, implant or fracture site infection related to the study site.
- Patient is pregnant, potentially pregnant, or lactating.
- Patient likely to have difficulty maintaining follow-up, including:
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 |
|---|---|---|
| Standard of careParticipants in the control group will receive standard care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection. Topical antibiotics are allowed, if SOC for the institution, but are not mandated. | Drug | Control |
| Vancomycin and TobramycinThe patients in the SEXTANT cohort will receive 72 hours of targeted systemic antibiotic therapy (Table 2) and will have 1000 mg of Vancomycin and 1200 mg of Tobramycin administered to the wound surface, fracture site, and exposed hardware (if any) just prior to suture closure of the wound or flap. 72-hour of systemic gram-positive and gram-negative antibiotic coverage to target the terminal wound bioburden. The antibiotics coverage proposed as the primary choice includes PO Ciprofloxacin + PO linezolid or IV Ciprofloxacin and IV Vancomycin. The preferred antibiotic regimen will be decided by study's ID team, in cooperation with the ID and Antibiotic Stewardship teams at each site. Antibiotic recommendations will be adjusted, if needed, to account for a Site's bacteria susceptibility / resistance profile, or the specific needs of an individual patient. | Drug | Treatment |
Primary outcome
Deep surgical site infection
Time frame: 180 days from final wound closure/cloverage
To determine if the SEXTANT treatment strategy designed to address the modern wound bioburden at the time of delayed wound closure/coverage is superior to the standard-of-care (SOC) antibiotic protocol. Our primary comparison will be the proportion of fracture-related infections (FRI) under the SEXTANT arm versus the FRI proportion for those under standard of care in the first 180 days following final wound closure/coverage. One-year rates of FRI will also be assessed.
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 Jul 2026.
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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.
Micahel J Bosse, MD principal investigator
Carolinas Medical Center
Rachel Seymour, PhD principal investigator
Atrium Health Musculoskeletal Institute Research
Renan C Castillo, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vancomycin and Tobramycin in people with Post Operative Surgical Site Infection, run by Major Extremity Trauma Research Consortium at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. 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 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. 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 Suna Chung, MPH (4105023357, schung60@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep surgical site infection (time frame: 180 days from final wound closure/cloverage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2026.