Prophylactic Antibiotic in Subtalar Fusion Surgery

NCT ID: NCT06527989

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-11-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ceftriaxone 2 grams

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

Group Type EXPERIMENTAL

Ceftriaxone 2000 mg

Intervention Type DRUG

antibiotic prophylaxis

ceftriaxone 10 grams

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

Group Type EXPERIMENTAL

Ceftriaxone 2000 mg

Intervention Type DRUG

antibiotic prophylaxis

Interventions

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Ceftriaxone 2000 mg

antibiotic prophylaxis

Intervention Type DRUG

Other Intervention Names

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ceftriaxone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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ibram romany labib nashed

resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wael Y Eladly

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Ibram R Labib

Role: CONTACT

+201095022190

Amr A Elsayed

Role: CONTACT

+201007788699

References

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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.

Reference Type RESULT
PMID: 25631195 (View on PubMed)

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.

Reference Type RESULT
PMID: 26229155 (View on PubMed)

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.

Reference Type RESULT
PMID: 38022210 (View on PubMed)

Other Identifiers

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antibiotic prophylaxis

Identifier Type: -

Identifier Source: org_study_id

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