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Clinical trial

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

ID
Name
57490822.9.0000.5404
Description
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.
Trial arms
Trial start
2023-08-08
Estimated PCD
2025-08-08
Trial end
2025-09-08
Status
Not yet recruiting
Treatment
Antibiotic
the individual will receive 1 dose of antibiotic during anesthetic induction
Arms:
antibiotic prophylaxis
placebo
the individual will receive 10 ml of saline during anesthetic induction
Arms:
placebo
Size
51
Primary endpoint
Surgical wound infection
30 days
Eligibility criteria
Inclusion Criteria: * individuals with clean soft tissue conditions of the upper limb requiring surgery Exclusion Criteria: * abandonment of treatment * ASA \> 3
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 51, 'type': 'ESTIMATED'}}
Updated at
2023-08-14

1 organization

1 product

1 indication

Organization
Marcos Felipe Marcatto de Abreu
Product
Antibiotic
Indication
Soft Tissue Injuries