Prophylactic Antibiotic in Subtalar Fusion Surgery

NCT06527989 | Not Yet Recruiting Phase 2

• 1 other identifier: antibiotic prophylaxis
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ceftriaxone 2 grams

EXPERIMENTAL

Single dose 2grams of ceftriaxone in 1st 24 hr Postoperative

Drug: Ceftriaxone 2000 mg

ceftriaxone 10 grams

EXPERIMENTAL

Multiple doses 2 grams of ceftriaxone every 24 hrs for 5 days

Drug: Ceftriaxone 2000 mg

Interventions

Ceftriaxone 2000 mg DRUG

antibiotic prophylaxis

Also known as: ceftriaxone

ceftriaxone 10 grams; ceftriaxone 2 grams

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• 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.

  PMID: 25631195 RESULT

• 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.

  PMID: 26229155 RESULT

• 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.

  PMID: 38022210 RESULT

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Wael Y Eladly

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ibram R Labib

CONTACT

+201095022190; ibram.romany@gmail.com

Amr A Elsayed

CONTACT

+201007788699; Amr.a.mohamed@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Model Details: 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

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 30, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share