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

NCT ID: NCT05990842

Last Updated: 2023-08-14

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-08

Study Completion Date

2025-09-08

Brief Summary

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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.

Detailed Description

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Conditions

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Soft Tissue Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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antibiotic prophylaxis

Group Type EXPERIMENTAL

Antibiotic

Intervention Type DRUG

the individual will receive 1 dose of antibiotic during anesthetic induction

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

the individual will receive 10 ml of saline during anesthetic induction

Interventions

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Antibiotic

the individual will receive 1 dose of antibiotic during anesthetic induction

Intervention Type DRUG

placebo

the individual will receive 10 ml of saline during anesthetic induction

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* individuals with clean soft tissue conditions of the upper limb requiring surgery

Exclusion Criteria

* abandonment of treatment
* ASA \> 3
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marcos Felipe Marcatto de Abreu

OTHER

Sponsor Role lead

Responsible Party

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Marcos Felipe Marcatto de Abreu

Medical Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Marcos M de Abreu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Campinas, Brazil

Central Contacts

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Marcos M Abreu, MD

Role: CONTACT

+55 19 3521-7512

Other Identifiers

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57490822.9.0000.5404

Identifier Type: -

Identifier Source: org_study_id

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