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Prophylactic Antibiotic in Subtalar Fusion Surgery

Prophylactic Antibiotic in Subtalar Fusion Surgery: 24 Hours Versus 5 Days

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06527989
Enrollment
102
Registered
2024-07-30
Start date
2024-09-01
Completion date
2025-11-01
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

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.

Interventions

antibiotic prophylaxis

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
assessment of incidence rate of surgical site infectionbaselinesurgical 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

Contacts

Primary ContactIbram R Labib
ibram.romany@gmail.com+201095022190
Backup ContactAmr A Elsayed
Amr.a.mohamed@aun.edu.eg+201007788699

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026