"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
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
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
NCT ID
NCT05990842
First Posted
August 6, 2023
Last Updated
August 6, 2023
Sponsor
Marcos Felipe Marcatto de Abreu
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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