A Phase 3 interventional study of Tobramycin and Placebo: normal saline in Fractures, Open, sponsored by University of Virginia. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-06-15.
Sponsored by University of Virginia · Phase 3, Interventional, and Treatment
The primary objective of this study is to investigate the effectiveness of local antibiotic versus placebo in the prevention of infections in open fractures. The study will assess whether local treatment of open fractures with the antibiotic tobramycin (in addition to standard systemic antibiotics) will decrease the risk and rate of infection, and rate of re-operation. This will be studied using a randomized controlled clinical trial design in adult population of age 18-70 years who present with open fractures. About 133 subjects will be recruited in this study at UVA.
53 studies on the registry are indexed under Fractures, Open; 14 are open to participants now.
This study's enrollment of 11 is below the median of 90 across 40 interventional studies indexed under Fractures, Open.
Browse Fractures, Open studies →University of Virginia is the lead sponsor of 675 studies on the registry; 138 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 42 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be injected locally at the wound cavity (i.e. fracture site, surrounding soft tissue which include muscle, and subcutaneous space) with 80mg/40mL of tobramycin after wound closure. Systemic antibiotic will not be withheld and will be done along side the intervention.
Drug: Tobramycin
Subjects will be injected locally with 40 mL 0.9% NS after wound closure. Systemic antibiotic will not be withheld and will be done along side the intervention.
Other: Placebo: normal saline
Presence of Wound Infection
Infection will be defined as major and minor, with major indicated by return to the operating room for irrigation and debridement. Minor infection is represented by documentation of cellulitis or superficial infection at surgical site and administration of oral antibiotics
Time frame: 6 weeks post op
| Milestone | Antibiotic | Normal Saline |
|---|---|---|
| Started | 8 | 3 |
| Completed | 8 | 3 |
| Not completed | 0 | 0 |
Infection will be defined as major and minor, with major indicated by return to the operating room for irrigation and debridement. Minor infection is represented by documentation of cellulitis or superficial infection at surgical site and administration of oral antibiotics
| Participants | Antibiotic | Normal Saline |
|---|---|---|
| Presence of Wound Infection | 0 | 0 |
Collected over 6 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Antibiotic | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Normal Saline | 0/3 (0%) | 1/3 (33.3%) | 0/3 (0%) |
| Event | Antibiotic | Normal Saline |
|---|---|---|
| Suicide IdeationPsychiatric disorders | — | 1/3 |
Subjects approached and enrolled presented to our emergency department with open fractures
| Age, Categorical(Participants) | Antibiotic | Normal Saline | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 3 | 10 |
| >=65 years | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | Antibiotic | Normal Saline | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 5 | 1 | 6 |
| Race (NIH/OMB)(Participants) | Antibiotic | Normal Saline | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 8 | 3 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Antibiotic | Normal Saline | Total |
|---|---|---|---|
| United States | 8 | 3 | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2015 to primary completion in Mar 2019, 44 months.
Results were first posted in Jun 2023, 4 years 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tobramycin