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NCT Number: NCT06527989

Prophylactic Antibiotic in Subtalar Fusion Surgery

Assessment of surgical site infection when using postoperative antibiotic prophylaxis in subtalar fusion surgery 24hours versus 5 days

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • posttraumatic subtallar osteoarthritis
  • adult age 18 up to 60
  • good skin condition healthy

Exclusion criteria

  • comorbidities such as Diabetes Mellitus, Autoimmune diseases
  • previous foot surgery
  • wounds near surgical incision
  • skin infection

Treatment and study plan

Ceftriaxone 2000 mg

Drug

antibiotic prophylaxis

Other names: ceftriaxone

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Amr A Elsayed

CONTACT

[email protected]

+201007788699

Ibram R Labib

CONTACT

[email protected]

+201095022190

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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