Prophylactic Antibiotic in Subtalar Fusion Surgery

Phase 2

Not yet recruiting

• Conditions: Surgical Site Infection
• Interventions: Drug: Ceftriaxone 2000 mg

• Registration Number: NCT06527989
• Lead Sponsor: Assiut University

Brief Summary

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 Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30
• Study Start: 2024-09-01
• Primary Completion: 2025-09-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. posttraumatic subtallar osteoarthritis
2. adult age 18 up to 60
3. good skin condition healthy

Exclusion Criteria

1. comorbidities such as Diabetes Mellitus, Autoimmune diseases
2. previous foot surgery
3. wounds near surgical incision
4. skin infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ceftriaxone 2 grams	Ceftriaxone 2000 mg	Single dose 2grams of ceftriaxone in 1st 24 hr Postoperative
ceftriaxone 10 grams	Ceftriaxone 2000 mg	Multiple doses 2 grams of ceftriaxone every 24 hrs for 5 days

Primary Outcome Measures

Name	Time	Method
assessment of incidence rate of surgical site infection	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