Prophylactic Antibiotic in Subtalar Fusion Surgery

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

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Site Infection
• Intervention / Treatment: Drug: Ceftriaxone 2000 mg

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 Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Ibram R Labib; Phone Number: +201095022190; Email: ibram.romany@gmail.com
• Study Contact Backup: Name: Amr A Elsayed; Phone Number: +201007788699; Email: Amr.a.mohamed@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ceftriaxone 2 grams; Single dose 2grams of ceftriaxone in 1st 24 hr Postoperative	Drug: Ceftriaxone 2000 mg; antibiotic prophylaxis; Other Names: ceftriaxone
Experimental: ceftriaxone 10 grams; Multiple doses 2 grams of ceftriaxone every 24 hrs for 5 days	Drug: Ceftriaxone 2000 mg; antibiotic prophylaxis; Other Names: ceftriaxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Wael Y Eladly, Assiut University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wound Infection; Surgical Wound Infection; Anti-Infective Agents; Anti-Bacterial Agents; Third Generation Cephalosporins; Beta Lactam Antibiotics; Ceftriaxone
• Other Study ID Numbers: antibiotic prophylaxis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No