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NCT05990842 Clinical Trial

"Enhancing Surgical Safety in Developing Nations: Investigating Antibiotics' Role in Hand Surgeries."

Soft Tissue Injuries Clinical Trial

Official title:
"Antibiotic Prophylaxis in Clean Soft Tissue Hand Surgery Among a Population in a Developing Country: A Randomized, Parallel, Triple-Blind, Placebo-Controlled Clinical Trial"

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05990842
Other study ID # 57490822.9.0000.5404
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 8, 2023
Est. completion date September 8, 2025

Study information
Verified date August 2023
Source University of Campinas, Brazil
Contact Marcos M Abreu, MD
Phone +55 19 3521-7512
Email marcatto@unicamp.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the use of antibiotics with no use in people undergoing soft tissue hand surgery in developing countries. The main question it aims to answer is: • Is an antibiotic necessary for this type of surgery in this population? Researchers will compare a group of patients who receives antibiotics during the surgical procedure with a group who receives no antibiotics to see if infection rates are the same.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 51
Est. completion date September 8, 2025
Est. primary completion date August 8, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - individuals with clean soft tissue conditions of the upper limb requiring surgery Exclusion Criteria: - abandonment of treatment - ASA > 3

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Antibiotic
the individual will receive 1 dose of antibiotic during anesthetic induction
Other:
• placebo
the individual will receive 10 ml of saline during anesthetic induction

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Marcos Felipe Marcatto de Abreu

Outcome
Type Measure Description Time frame Safety issue
Primary Surgical wound infection CDC protocol for surgical wound infection surveillance 30 days
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