Study Results
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Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
102 participants
INTERVENTIONAL
2024-09-01
2025-11-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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
PREVENTION
NONE
Study Groups
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ceftriaxone 2 grams
Single dose 2grams of ceftriaxone in 1st 24 hr Postoperative
Ceftriaxone 2000 mg
antibiotic prophylaxis
ceftriaxone 10 grams
Multiple doses 2 grams of ceftriaxone every 24 hrs for 5 days
Ceftriaxone 2000 mg
antibiotic prophylaxis
Interventions
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Ceftriaxone 2000 mg
antibiotic prophylaxis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. adult age 18 up to 60
3. good skin condition healthy
Exclusion Criteria
2. previous foot surgery
3. wounds near surgical incision
4. skin infection
18 Years
60 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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ibram romany labib nashed
resident
Principal Investigators
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Wael Y Eladly
Role: STUDY_DIRECTOR
Assiut University
Central Contacts
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References
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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.
Dhammi 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.
Upadhyyaya 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.
Other Identifiers
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antibiotic prophylaxis
Identifier Type: -
Identifier Source: org_study_id
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