Open FracturePhase 4NCT03560232
Noninferiority Comparison of Prophylactic Open Fracture Antimicrobial Regimens
A Phase 4 study testing Ceftriaxone, Ampicillin/sulbactam and Piperacillin/tazobactam in people with Open Fracture and Post-Op Wound Infection, run by Mercy Health Ohio at 2 sites in United States.
Trial summary
To demonstrate noninferiority of three different empiric antimicrobial regimens compared to the traditional antimicrobial regimen for the management of grade III open fractures as well as evaluate outcomes among these groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Fracture, Post-Op Wound Infection
- What is being tested?
- Ceftriaxone, Ampicillin/sulbactam and Piperacillin/tazobactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jul 2018to 19 Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
Who may be able to join
- Age great than/equal to 18 years
- Diagnosis of Grade III open fracture
Who cannot join
- Water-borne injury
- Farm-related injury
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. Joseph Warren Hospital
Warren, Ohio, 44484
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501
About this study
Official title: A Randomized Controlled Trial Assessing Noninferiority of Three Antimicrobial Regimens for the Treatment of Grade III Open Fractures
To demonstrate noninferiority of three different empiric antimicrobial regimens compared to the traditional antimicrobial regimen for the management of grade III open fractures as well as evaluate outcomes among these groups.
Read the detailed description
Per the EAST practice management guidelines, an open fracture is defined as one in which the fracture fragments communicate with the environment through a break in the skin. The presence of an open fracture, either isolated or as part of a multiple injury complex, increases the risk of infection and soft tissue complications. Open fractures are further classified into Grade I - Grade III fractures per the Gustilo Classification. Grade III fractures are those with the highest likelihood of contamination and infection with infection rates ranging from 10% to 42%.
EAST guidelines currently recommend systemic gram positive coverage for all open fractures with the addition of gram negative coverage for all Grade III fractures. Antibiotics should be initiated as soon as possible following the injury and should be continued for 72 hours after the injury or not greater than 24 hours after soft tissue coverage was obtained. Traditionally, patients received the combination of Cefazolin and Gentamicin as the preferred prophylactic antibiotic regimen, despite the need for multiple antibiotics and the risk of nephrotoxicity associated with aminoglycosides. Whether there is clinically a more ideal prophylactic antibiotic available remains to be seen. This proposed research initiative is intended to evaluate several antibiotic regimens with similar spectrums of activity to see if there is an equally effective single agent with minimal nephrotoxicity associated with its use. In selecting the study antibiotics to be utilized in the protocol, available information was obtained regarding timing of antibiotics, organisms identified by culture results, and any studies available on specific antibiotic regimens. In regards to timing, there is evidence to support that time to antibiotics and time to the operating room may be more important than the particular antibiotic itself. Additionally, a recent study from 2015 looked at the organisms identified from culture results for Grade I through Grade III fractures in Germany. The vast majority of cultures obtained were gram positive organisms, even in the Grade III fractures, and included Staphylococcus epidermidis, Staphylococcus aureus, Staphylococcus capitis, various Streptococcus species, Enterococcus faecium and Corynebacterium. Interestingly, the only gram negative organism identified in the study was Escherichia coli. Lastly, when trying to identify antibiotic specific studies, a recent study was identified looking at Ceftriaxone as the agent of choice, while limiting the use of vancomycin and aminoglycosides. The conclusion of the study showed a significant decrease in vancomycin and aminoglycosides administered with no increase in infection rates.
Here at St. Elizabeth Youngstown Hospital, the investigator's current trauma and orthopedics practice management guideline has been reviewed and changed multiple times in the past several years. For the vast majority of time, the recommendation has been to use the traditional cefazolin/gentamicin combination. However, several cases of nephrotoxicity led to some hesitation in utilizing this regimen. Therefore, for a short time period, piperacillin/tazobactam was being used for all Grade III fractures instead. At present however, due to conflicting concerns regarding antimicrobial stewardship with utilizing broad spectrum piperacillin/tazobactam with the nephrotoxicity concerns of gentamicin, the approved guideline utilizes cefazolin/gentamicin for patients under 65 years of age and piperacillin/tazobactam for all patients greater than or equal to 65 years of age. This study aims to evaluate non-inferiority of ampicillin/sulbactam, ceftriaxone, and piperacillin/tazobactam when compared to the traditional regimen of cefazolin/gentamicin for grade III open fractures.
- Conditions
- Open Fracture, Post-Op Wound Infection
- Being tested
- Ceftriaxone, Ampicillin/sulbactam, Piperacillin/tazobactam, Cefazolin + Gentamicin, Clindamycin + Gentamicin
- Keywords
- Open Fracture, Wound Infection, Antimicrobial Prophylaxis, Cefazolin, Gentamicin, Ceftriaxone, Ampicillin/Sulbactam, Clindamycin, Piperacillin/tazobactam
- Medical subject headings
- Fractures, Open, Surgical Wound Infection, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftriaxoneDrug
Also called Rocephin
See arm description
Ampicillin/sulbactamDrug
Also called Unasyn
See arm description
Piperacillin/tazobactamDrug
Also called Zosyn
See arm description
Cefazolin + GentamicinDrug
Also called Ancef + Garamycin
See arm description
Clindamycin + GentamicinDrug
Also called Cleocin + Garamycin
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin + Gentamicin | Active comparator | [Cefazolin]
Initial dose:
* Cefazolin 2g IV x1 dose (patient weight < 120kg)
* Cefazolin 3g IV x1 dose (patient weight >/= 120kg)
Subsequent dose:
* Cefazolin 2g IV every 8 hrs (CrCl >/= 40 mL/min)
* Cefazolin 2g IV every 12 hrs (CrCl 20-39 mL/min)
* Cefazolin 2g IV every 24 hrs (CrCl < 20 mL/min)
Duration:
* 24 hrs post-op after soft tissue coverage or total of 72 hrs, whichever comes first
[Gentamicin]
Initial dose:
* If Patient age </= 80 years old: 5 mg/kg adjusted body weight x1 dose (Max dose 500 mg)
* If Patient age >80 years old: 3 mg/kg adjusted body weight x1 dose (Max dose 300 mg)
Subsequent dose:
* Pharmacy Consult to dose gentamicin
Duration:
* 24 hrs post-op after soft tissue coverage or total of 72 hrs, whichever comes first Receives: Drug: Cefazolin + Gentamicin |
| Ceftriaxone | Active comparator | Initial dose:
* Ceftriaxone 2g IV x1 dose
Subsequent dose:
* Ceftriaxone 2g IV every 24 hours
Duration:
* One dose post-op after soft tissue coverage or total of 72 hours, whichever comes first Receives: Drug: Ceftriaxone |
| Ampicillin/Sulbactam | Active comparator | Initial dose:
* Ampicillin/Sulbactam 3g IV x1 dose
Subsequent dose:
* Ampicillin/Sulbactam 3g IV every 6 hours (CrCl >/= 30 mL/min)
* Ampicillin/Sulbactam 3g IV every 12 hours (CrCl 15-29 mL/min)
* Ampicillin/Sulbactam 3g IV every 24 hours (CrCl <15 mL/min)
Duration:
* 24 hours post-op after soft tissue coverage or total of 72 hours, whichever comes first Receives: Drug: Ampicillin/sulbactam |
| Piperacillin/Tazobactam | Active comparator | Initial dose:
* Piperacillin/Tazobactam 4.5g IV x1 dose over 30 minutes
Subsequent dose:
* Piperacillin/Tazobactam 3.375g IV every 8 hours over 4 hours (CrCl >/= 20 mL/min)
* Piperacillin/Tazobactam 3.375g IV every 12 hours over 4 hours (CrCl < 20 mL/min)
Duration:
* 24 hours post-op after soft tissue coverage or total of 72 hours, whichever comes first Receives: Drug: Piperacillin/tazobactam |
| Clindamycin + Gentamicin | Other | Patients with known Penicillin allergy will receive:
[Clindamycin]
Initial dose:
* Clindamycin 900mg IV x1 dose
Subsequent dose:
* Clindamycin 600mg IV every 8 hours
Duration:
* 24 hours post-op after soft tissue coverage or total of 72 hours, whichever comes first
[Gentamicin]
Initial dose:
* If Patient age </= 80 years old: 5 mg/kg adjusted body weight x1 dose (Max dose 500 mg)
* If Patient age >80 years old: 3 mg/kg adjusted body weight x1 dose (Max dose 300 mg)
Subsequent dose:
* Pharmacy Consult to dose gentamicin
Duration:
* 24 hours post-op after soft tissue coverage or total of 72 hours, whichever comes first Receives: Drug: Clindamycin + Gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-surgical site wound infections
The primary outcome for this study is the number of post-surgical site wound infections, defined as initiation of antibiotics for surgical-site infection and/or need for surgical debridement of site. The acceptable infection rate per Trauma Practice Management Guidelines states a rate less than 20%.
Measured: 1 year
Secondary outcomes (3)
Incidence of acute kidney injury
Incidence of acute kidney injury during hospital admission will be collected and compared to the other antibiotic regimens.
Acute kidney injury is defined as (per KDIGO guidelines):
- An increase in SCr by 0.3 mg/dL within 48 hours OR
- Increase in SCr to 1.5 times baseline within the previous 7 days OR
- Urine volume less than 0.5 mL/kg/h for 6 hours
Measured: Hospital admission
Average cost of antibiotic therapy per patient
Cost per patient of each antibiotic therapy will be calculated and compared to the other antibiotic regimens
Measured: Hospital admission
Time to antibiotic therapy
Time from arrival to receiving first dose of antibiotic therapy will be collected (Goal within 30 minutes of arrival).
Measured: Hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start9 Jul 2018
- Primary completion19 Feb 2020
- Study completion19 Feb 2020
Why it stopped: Unable to recruit patients in a timely fashion and unable to recruit sufficient patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Open 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Health Ohio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie I Rine, PharmD, Study chair, MercyHealth YoungstownPaul T Miller, PharmD, Study chair, MercyHealth YoungstownTyson T Schrickel, MD, Study chair, MercyHealth YoungstownStuart Drew, DO, Study chair, MercyHealth YoungstownDavid J Gemmel, PhD, Study chair, MercyHealth YoungstownChad W Donley, MD, Principal investigator, MercyHealth YoungstownAllison R Lauver, PharmD, Study chair, MercyHealth Youngstown
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560232
- Sponsor's protocol ID
- 17-028
- Status last verified
- Sep 2020
- First submitted
- 6 Jun 2018
- Last updated
- 11 Sep 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gustilo RB, Mendoza RM, Williams DN. Problems in the management of type III (severe) open fractures: a new classification of type III open fractures. J Trauma. 1984 Aug;24(8):742-6. doi: 10.1097/00005373-198408000-00009.
PubMed 6471139Hoff WS, Bonadies JA, Cachecho R, Dorlac WC. East Practice Management Guidelines Work Group: update to practice management guidelines for prophylactic antibiotic use in open fractures. J Trauma. 2011 Mar;70(3):751-4. doi: 10.1097/TA.0b013e31820930e5. No abstract available.
PubMed 21610369Lack WD, Karunakar MA, Angerame MR, Seymour RB, Sims S, Kellam JF, Bosse MJ. Type III open tibia fractures: immediate antibiotic prophylaxis minimizes infection. J Orthop Trauma. 2015 Jan;29(1):1-6. doi: 10.1097/BOT.0000000000000262.
PubMed 25526095Otchwemah R, Grams V, Tjardes T, Shafizadeh S, Bathis H, Maegele M, Messler S, Bouillon B, Probst C. Bacterial contamination of open fractures - pathogens, antibiotic resistances and therapeutic regimes in four hospitals of the trauma network Cologne, Germany. Injury. 2015 Oct;46 Suppl 4:S104-8. doi: 10.1016/S0020-1383(15)30027-9.
PubMed 26542854Rodriguez L, Jung HS, Goulet JA, Cicalo A, Machado-Aranda DA, Napolitano LM. Evidence-based protocol for prophylactic antibiotics in open fractures: improved antibiotic stewardship with no increase in infection rates. J Trauma Acute Care Surg. 2014 Sep;77(3):400-7; discussion 407-8; quiz 524. doi: 10.1097/TA.0000000000000398.
PubMed 25159242Lenarz CJ, Watson JT, Moed BR, Israel H, Mullen JD, Macdonald JB. Timing of wound closure in open fractures based on cultures obtained after debridement. J Bone Joint Surg Am. 2010 Aug 18;92(10):1921-6. doi: 10.2106/JBJS.I.00547. Epub 2010 Jul 21.
PubMed 20660225
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Assessing Noninferiority of Three Antimicrobial Regimens for the Treatment of Grade III Open Fractures
- ClinicalTrials.gov ID
- NCT03560232
- Acronym / sponsor ID
- 17-028
- Conditions
- Open Fracture, Post-Op Wound Infection
- Keywords
- Open Fracture, Wound Infection, Antimicrobial Prophylaxis, Cefazolin, Gentamicin, Ceftriaxone, Ampicillin/Sulbactam, Clindamycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit patients in a timely fashion and unable to recruit sufficient patients
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mercy Health OhioUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 18 Jun 2018 (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.
To demonstrate noninferiority of three different empiric antimicrobial regimens compared to the traditional antimicrobial regimen for the management of grade III open fractures as well as evaluate outcomes among these groups.
Detailed description
Per the EAST practice management guidelines, an open fracture is defined as one in which the fracture fragments communicate with the environment through a break in the skin. The presence of an open fracture, either isolated or as part of a multiple injury complex, increases the risk of infection and soft tissue complications. Open fractures are further classified into Grade I - Grade III fractures per the Gustilo Classification. Grade III fractures are those with the highest likelihood of contamination and infection with infection rates ranging from 10% to 42%.
EAST guidelines currently recommend systemic gram positive coverage for all open fractures with the addition of gram negative coverage for all Grade III fractures. Antibiotics should be initiated as soon as possible following the injury and should be continued for 72 hours after the injury or not greater than 24 hours after soft tissue coverage was obtained. Traditionally, patients received the combination of Cefazolin and Gentamicin as the preferred prophylactic antibiotic regimen, despite the need for multiple antibiotics and the risk of nephrotoxicity associated with aminoglycosides. Whether there is clinically a more ideal prophylactic antibiotic available remains to be seen. This proposed research initiative is intended to evaluate several antibiotic regimens with similar spectrums of activity to see if there is an equally effective single agent with minimal nephrotoxicity associated with its use. In selecting the study antibiotics to be utilized in the protocol, available information was obtained regarding timing of antibiotics, organisms identified by culture results, and any studies available on specific antibiotic regimens. In regards to timing, there is evidence to support that time to antibiotics and time to the operating room may be more important than the particular antibiotic itself. Additionally, a recent study from 2015 looked at the organisms identified from culture results for Grade I through Grade III fractures in Germany. The vast majority of cultures obtained were gram positive organisms, even in the Grade III fractures, and included Staphylococcus epidermidis, Staphylococcus aureus, Staphylococcus capitis, various Streptococcus species, Enterococcus faecium and Corynebacterium. Interestingly, the only gram negative organism identified in the study was Escherichia coli. Lastly, when trying to identify antibiotic specific studies, a recent study was identified looking at Ceftriaxone as the agent of choice, while limiting the use of vancomycin and aminoglycosides. The conclusion of the study showed a significant decrease in vancomycin and aminoglycosides administered with no increase in infection rates.
Here at St. Elizabeth Youngstown Hospital, the investigator's current trauma and orthopedics practice management guideline has been reviewed and changed multiple times in the past several years. For the vast majority of time, the recommendation has been to use the traditional cefazolin/gentamicin combination. However, several cases of nephrotoxicity led to some hesitation in utilizing this regimen. Therefore, for a short time period, piperacillin/tazobactam was being used for all Grade III fractures instead. At present however, due to conflicting concerns regarding antimicrobial stewardship with utilizing broad spectrum piperacillin/tazobactam with the nephrotoxicity concerns of gentamicin, the approved guideline utilizes cefazolin/gentamicin for patients under 65 years of age and piperacillin/tazobactam for all patients greater than or equal to 65 years of age. This study aims to evaluate non-inferiority of ampicillin/sulbactam, ceftriaxone, and piperacillin/tazobactam when compared to the traditional regimen of cefazolin/gentamicin for grade III open fractures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Randomized, open-label
| Arm | Type | Receives |
|---|---|---|
| Cefazolin + Gentamicin | Active comparator | Drug: Cefazolin + Gentamicin[Cefazolin] Initial dose: * Cefazolin 2g IV x1 dose (patient weight < 120kg) * Cefazolin 3g IV x1 dose (patient weight >/= 120kg) Subsequent dose: * Cefazolin 2g IV every 8 hrs (CrCl >/= 40 mL/min) * Cefazolin 2g IV every 12 hrs (CrCl 20-39 mL/min) * Cefazolin 2g IV every 24 hrs (CrCl < 20 mL/min) Duration: * 24 hrs post-op after soft tissue coverage or total of 72 hrs, whichever comes first [Gentamicin] Initial dose: * If Patient age </= 80 years old: 5 mg/kg adjusted body weight x1 dose (Max dose 500 mg) * If Patient age >80 years old: 3 mg/kg adjusted body weight x1 dose (Max dose 300 mg) Subsequent dose: * Pharmacy Consult to dose gentamicin Duration: * 24 hrs post-op after soft tissue coverage or total of 72 hrs, whichever comes first |
| Ceftriaxone | Active comparator | Drug: CeftriaxoneInitial dose: * Ceftriaxone 2g IV x1 dose Subsequent dose: * Ceftriaxone 2g IV every 24 hours Duration: * One dose post-op after soft tissue coverage or total of 72 hours, whichever comes first |
| Ampicillin/Sulbactam | Active comparator | Drug: Ampicillin/sulbactamInitial dose: * Ampicillin/Sulbactam 3g IV x1 dose Subsequent dose: * Ampicillin/Sulbactam 3g IV every 6 hours (CrCl >/= 30 mL/min) * Ampicillin/Sulbactam 3g IV every 12 hours (CrCl 15-29 mL/min) * Ampicillin/Sulbactam 3g IV every 24 hours (CrCl <15 mL/min) Duration: * 24 hours post-op after soft tissue coverage or total of 72 hours, whichever comes first |
| Piperacillin/Tazobactam | Active comparator | Drug: Piperacillin/tazobactamInitial dose: * Piperacillin/Tazobactam 4.5g IV x1 dose over 30 minutes Subsequent dose: * Piperacillin/Tazobactam 3.375g IV every 8 hours over 4 hours (CrCl >/= 20 mL/min) * Piperacillin/Tazobactam 3.375g IV every 12 hours over 4 hours (CrCl < 20 mL/min) Duration: * 24 hours post-op after soft tissue coverage or total of 72 hours, whichever comes first |
| Clindamycin + Gentamicin | Other | Drug: Clindamycin + GentamicinPatients with known Penicillin allergy will receive: [Clindamycin] Initial dose: * Clindamycin 900mg IV x1 dose Subsequent dose: * Clindamycin 600mg IV every 8 hours Duration: * 24 hours post-op after soft tissue coverage or total of 72 hours, whichever comes first [Gentamicin] Initial dose: * If Patient age </= 80 years old: 5 mg/kg adjusted body weight x1 dose (Max dose 500 mg) * If Patient age >80 years old: 3 mg/kg adjusted body weight x1 dose (Max dose 300 mg) Subsequent dose: * Pharmacy Consult to dose gentamicin Duration: * 24 hours post-op after soft tissue coverage or total of 72 hours, whichever comes first |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age great than/equal to 18 years
- Diagnosis of Grade III open fracture
Key exclusion criteria (2 listed)
- Water-borne injury
- Farm-related injury
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 |
|---|---|---|
| CeftriaxoneAlso: RocephinSee arm description | Drug | Ceftriaxone |
| Ampicillin/sulbactamAlso: UnasynSee arm description | Drug | Ampicillin/Sulbactam |
| Piperacillin/tazobactamAlso: ZosynSee arm description | Drug | Piperacillin/Tazobactam |
| Cefazolin + GentamicinAlso: Ancef + GaramycinSee arm description | Drug | Cefazolin + Gentamicin |
| Clindamycin + GentamicinAlso: Cleocin + GaramycinSee arm description | Drug | Clindamycin + Gentamicin |
Primary outcome
Post-surgical site wound infections
Time frame: 1 year
The primary outcome for this study is the number of post-surgical site wound infections, defined as initiation of antibiotics for surgical-site infection and/or need for surgical debridement of site. The acceptable infection rate per Trauma Practice Management Guidelines states a rate less than 20%.
3 secondary outcomes
Incidence of acute kidney injury
Time frame: Hospital admission
Average cost of antibiotic therapy per patient
Time frame: Hospital admission
Time to antibiotic therapy
Time frame: Hospital admission
Results and safety
The study was stopped early (reason given: Unable to recruit patients in a timely fashion and unable to recruit sufficient patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Background: PubMed 6471139Gustilo RB, Mendoza RM, Williams DN. Problems in the management of type III (severe) open fractures: a new classification of type III open fractures. J Trauma. 1984 Aug;24(8):742-6. doi: 10.1097/00005373-198408000-00009.
- Background: PubMed 21610369Hoff WS, Bonadies JA, Cachecho R, Dorlac WC. East Practice Management Guidelines Work Group: update to practice management guidelines for prophylactic antibiotic use in open fractures. J Trauma. 2011 Mar;70(3):751-4. doi: 10.1097/TA.0b013e31820930e5. No abstract available.
- Background: PubMed 25526095Lack WD, Karunakar MA, Angerame MR, Seymour RB, Sims S, Kellam JF, Bosse MJ. Type III open tibia fractures: immediate antibiotic prophylaxis minimizes infection. J Orthop Trauma. 2015 Jan;29(1):1-6. doi: 10.1097/BOT.0000000000000262.
- Background: PubMed 26542854Otchwemah R, Grams V, Tjardes T, Shafizadeh S, Bathis H, Maegele M, Messler S, Bouillon B, Probst C. Bacterial contamination of open fractures - pathogens, antibiotic resistances and therapeutic regimes in four hospitals of the trauma network Cologne, Germany. Injury. 2015 Oct;46 Suppl 4:S104-8. doi: 10.1016/S0020-1383(15)30027-9.
- Background: PubMed 25159242Rodriguez L, Jung HS, Goulet JA, Cicalo A, Machado-Aranda DA, Napolitano LM. Evidence-based protocol for prophylactic antibiotics in open fractures: improved antibiotic stewardship with no increase in infection rates. J Trauma Acute Care Surg. 2014 Sep;77(3):400-7; discussion 407-8; quiz 524. doi: 10.1097/TA.0000000000000398.
- Background: PubMed 20660225Lenarz CJ, Watson JT, Moed BR, Israel H, Mullen JD, Macdonald JB. Timing of wound closure in open fractures based on cultures obtained after debridement. J Bone Joint Surg Am. 2010 Aug 18;92(10):1921-6. doi: 10.2106/JBJS.I.00547. Epub 2010 Jul 21.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Natalie I Rine, PharmD study chair
MercyHealth Youngstown
Paul T Miller, PharmD study chair
MercyHealth Youngstown
Tyson T Schrickel, MD study chair
MercyHealth Youngstown
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ceftriaxone, Ampicillin/sulbactam and Piperacillin/tazobactam in people with Open Fracture and Post-Op Wound Infection, run by Mercy Health Ohio at 2 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit patients in a timely fashion and unable to recruit sufficient patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-surgical site wound infections (time frame: 1 year). 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 NCT03560232, which also lists 6 linked publications.
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 11 Sep 2020.