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

Primary Purpose

Soft Tissue Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Antibiotic
placebo
Sponsored by
Marcos Felipe Marcatto de Abreu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Soft Tissue Injuries focused on measuring antibiotic prophylaxis, hand surgery, orthopedic surgery, postoperative care, surgical wound infection, developing country

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: individuals with clean soft tissue conditions of the upper limb requiring surgery Exclusion Criteria: abandonment of treatment ASA > 3

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    antibiotic prophylaxis

    placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Surgical wound infection
    CDC protocol for surgical wound infection surveillance

    Secondary Outcome Measures

    Full Information

    First Posted
    August 6, 2023
    Last Updated
    August 6, 2023
    Sponsor
    Marcos Felipe Marcatto de Abreu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05990842
    Brief Title
    "Enhancing Surgical Safety in Developing Nations: Investigating Antibiotics' Role in Hand Surgeries."
    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"
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 8, 2023 (Anticipated)
    Primary Completion Date
    August 8, 2025 (Anticipated)
    Study Completion Date
    September 8, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Marcos Felipe Marcatto de Abreu

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Soft Tissue Injuries
    Keywords
    antibiotic prophylaxis, hand surgery, orthopedic surgery, postoperative care, surgical wound infection, developing country

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    51 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    antibiotic prophylaxis
    Arm Type
    Experimental
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Antibiotic
    Intervention Description
    the individual will receive 1 dose of antibiotic during anesthetic induction
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    the individual will receive 10 ml of saline during anesthetic induction
    Primary Outcome Measure Information:
    Title
    Surgical wound infection
    Description
    CDC protocol for surgical wound infection surveillance
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: individuals with clean soft tissue conditions of the upper limb requiring surgery Exclusion Criteria: abandonment of treatment ASA > 3
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marcos M Abreu, MD
    Phone
    +55 19 3521-7512
    Email
    marcatto@unicamp.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marcos M de Abreu, MD
    Organizational Affiliation
    University of Campinas, Brazil
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    all data will be made available, with the exception of the name of the participant
    IPD Sharing Time Frame
    30 days after study publication
    IPD Sharing Access Criteria
    peer reviewer of a scientific magazine

    Learn more about this trial

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

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