Surgical Site InfectionPhase 2/3NCT06527989
Prophylactic Antibiotic in Subtalar Fusion Surgery
A Phase 2/3 study testing Ceftriaxone 2000 mg in people with Surgical Site Infection, run by Assiut University.
Trial summary
Assessment of surgical site infection when using postoperative antibiotic prophylaxis in subtalar fusion surgery 24hours versus 5 days Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Ceftriaxone 2000 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Nov 2025
- Phase
- Phase 2/3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- posttraumatic subtallar osteoarthritis
- adult age 18 up to 60
- good skin condition healthy
Who cannot join
- comorbidities such as Diabetes Mellitus, Autoimmune diseases
- previous foot surgery
- wounds near surgical incision
- skin infection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prophylactic Antibiotic in Subtalar Fusion Surgery: 24 Hours Versus 5 Days
Assessment of surgical site infection when using postoperative antibiotic prophylaxis in subtalar fusion surgery 24hours versus 5 days
Read the detailed description
Infection in orthopedic surgery is one of the most dreaded complications. Antibiotic prophylaxis should be utilized routinely in foot and ankle surgeries involving bone, utilizing hardware and prosthetic joints.
It is appropriate for the antibiotics to be administered within 60 minutes prior to surgery, discontinued within 24 hours after surgery, given prior to tourniquet inflation, and utilized routinely in prolonged foot and ankle surgery cases.
Narrow spectrum antibiotics covering Staphylococcus aureus should be utilized for prophylaxis in patients without a history of resistant infection. According to American Society of Health System Pharmacists (ASHP) cefazolin was the most used antibiotic in preoperative prophylaxis, combination of cefazolin with gentamicin was the second common regimen while 3rd generation cephalosporin were 3rd widely used antibiotics.
The controversy persists in administration of antibiotics varying from a single dose to 3 doses to 5 days or 14 days. In subtropical country, with a hot and humid climate is a conducive environment for both Gram-positive and Gram-negative bacterial colonization of skin. Therefore, we need studies tailored to our environment in Egypt Prevention of SSIs is critical for the health of patients, Economic efficiency, Antibiotic resistance considerations In conclusion, in many ways, the topic of prophylactic antibiotics in elective foot and ankle surgery is an unusual one, in that a relative divide exists between empirical science and common practice.
- Conditions
- Surgical Site Infection
- Being tested
- Ceftriaxone 2000 mg
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftriaxone 2000 mgDrug
Also called ceftriaxone
antibiotic prophylaxis
| Study group | Role | What they receive |
|---|---|---|
| ceftriaxone 2 grams | Experimental | Single dose 2grams of ceftriaxone in 1st 24 hr Postoperative Receives: Drug: Ceftriaxone 2000 mg |
| ceftriaxone 10 grams | Experimental | Multiple doses 2 grams of ceftriaxone every 24 hrs for 5 days Receives: Drug: Ceftriaxone 2000 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of incidence rate of surgical site infection
surgical site infection are further classified as either superficial or deep. Superficial infections involve only the skin and subcutaneous tissue, whereas deep infections involve deep tissue spaces or organs
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Preoperative: IV administration of prophylactic antibiotic 2gram ceftriaxone 30 to 60 min before surgical incision Intraoperative: if there is blood loss Postoperative: * Group A : Single dose 2grams of ceftriaxone in 1st 24 hr * Group B: Multiple doses 2 grams of ceftriaxone every 24 hrs for 5 days Follow up assessment of surgical wound 2 weeks after surgery for both groups then lately after 3 months
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ibram romany labib nashed, Assiut University
- Investigators
- Wael Y Eladly, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527989
- Sponsor's protocol ID
- antibiotic prophylaxis
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dayton P, DeVries JG, Landsman A, Meyr A, Schweinberger M. American college of foot and ankle surgeons' clinical consensus statement: perioperative prophylactic antibiotic use in clean elective foot surgery. J Foot Ankle Surg. 2015 Mar-Apr;54(2):273-9. doi: 10.1053/j.jfas.2015.01.004. Epub 2015 Jan 24.
PubMed 25631195Dhammi IK, Ul Haq R, Kumar S. Prophylactic antibiotics in orthopedic surgery: Controversial issues in its use. Indian J Orthop. 2015 Jul-Aug;49(4):373-6. doi: 10.4103/0019-5413.159556. No abstract available.
PubMed 26229155Upadhyyaya GK, Tewari S. Enhancing Surgical Outcomes: A Critical Review of Antibiotic Prophylaxis in Orthopedic Surgery. Cureus. 2023 Oct 27;15(10):e47828. doi: 10.7759/cureus.47828. eCollection 2023 Oct.
PubMed 38022210
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antibiotic in Subtalar Fusion Surgery: 24 Hours Versus 5 Days
- ClinicalTrials.gov ID
- NCT06527989
- Acronym / sponsor ID
- antibiotic prophylaxis
- Conditions
- Surgical Site Infection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 30 Jul 2024 (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.
Assessment of surgical site infection when using postoperative antibiotic prophylaxis in subtalar fusion surgery 24hours versus 5 days
Detailed description
Infection in orthopedic surgery is one of the most dreaded complications. Antibiotic prophylaxis should be utilized routinely in foot and ankle surgeries involving bone, utilizing hardware and prosthetic joints.
It is appropriate for the antibiotics to be administered within 60 minutes prior to surgery, discontinued within 24 hours after surgery, given prior to tourniquet inflation, and utilized routinely in prolonged foot and ankle surgery cases.
Narrow spectrum antibiotics covering Staphylococcus aureus should be utilized for prophylaxis in patients without a history of resistant infection. According to American Society of Health System Pharmacists (ASHP) cefazolin was the most used antibiotic in preoperative prophylaxis, combination of cefazolin with gentamicin was the second common regimen while 3rd generation cephalosporin were 3rd widely used antibiotics.
The controversy persists in administration of antibiotics varying from a single dose to 3 doses to 5 days or 14 days. In subtropical country, with a hot and humid climate is a conducive environment for both Gram-positive and Gram-negative bacterial colonization of skin. Therefore, we need studies tailored to our environment in Egypt Prevention of SSIs is critical for the health of patients, Economic efficiency, Antibiotic resistance considerations In conclusion, in many ways, the topic of prophylactic antibiotics in elective foot and ankle surgery is an unusual one, in that a relative divide exists between empirical science and common practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Preoperative: IV administration of prophylactic antibiotic 2gram ceftriaxone 30 to 60 min before surgical incision Intraoperative: if there is blood loss Postoperative: * Group A : Single dose 2grams of ceftriaxone in 1st 24 hr * Group B: Multiple doses 2 grams of ceftriaxone every 24 hrs for 5 days Follow up assessment of surgical wound 2 weeks after surgery for both groups then lately after 3 months
| Arm | Type | Receives |
|---|---|---|
| ceftriaxone 2 grams | Experimental | Drug: Ceftriaxone 2000 mgSingle dose 2grams of ceftriaxone in 1st 24 hr Postoperative |
| ceftriaxone 10 grams | Experimental | Drug: Ceftriaxone 2000 mgMultiple doses 2 grams of ceftriaxone every 24 hrs for 5 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- posttraumatic subtallar osteoarthritis
- adult age 18 up to 60
- good skin condition healthy
Key exclusion criteria (4 listed)
- comorbidities such as Diabetes Mellitus, Autoimmune diseases
- previous foot surgery
- wounds near surgical incision
- skin infection
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 |
|---|---|---|
| Ceftriaxone 2000 mgAlso: ceftriaxoneantibiotic prophylaxis | Drug | ceftriaxone 10 grams, ceftriaxone 2 grams |
Primary outcome
assessment of incidence rate of surgical site infection
Time frame: baseline
surgical site infection are further classified as either superficial or deep. Superficial infections involve only the skin and subcutaneous tissue, whereas deep infections involve deep tissue spaces or organs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Results publication: PubMed 25631195Dayton P, DeVries JG, Landsman A, Meyr A, Schweinberger M. American college of foot and ankle surgeons' clinical consensus statement: perioperative prophylactic antibiotic use in clean elective foot surgery. J Foot Ankle Surg. 2015 Mar-Apr;54(2):273-9. doi: 10.1053/j.jfas.2015.01.004. Epub 2015 Jan 24.
- Results publication: PubMed 26229155Dhammi IK, Ul Haq R, Kumar S. Prophylactic antibiotics in orthopedic surgery: Controversial issues in its use. Indian J Orthop. 2015 Jul-Aug;49(4):373-6. doi: 10.4103/0019-5413.159556. No abstract available.
- Results publication: PubMed 38022210Upadhyyaya GK, Tewari S. Enhancing Surgical Outcomes: A Critical Review of Antibiotic Prophylaxis in Orthopedic Surgery. Cureus. 2023 Oct 27;15(10):e47828. doi: 10.7759/cureus.47828. eCollection 2023 Oct.
- 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.
Wael Y Eladly study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ceftriaxone 2000 mg in people with Surgical Site Infection, run by Assiut University.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibram R Labib (+201095022190, ibram.romany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of incidence rate of surgical site infection (time frame: baseline). 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 NCT06527989, which also lists 3 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 30 Jul 2024.