"Enhancing Surgical Safety in Developing Nations: Investigating Antibiotics' Role in Hand Surgeries."
Sponsor
Marcos Felipe Marcatto de Abreu (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05990842
Collaborator
(none)
51
2
25
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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"
Anticipated Study Start Date
:
Aug 8, 2023
Anticipated Primary Completion Date
:
Aug 8, 2025
Anticipated Study Completion Date
:
Sep 8, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: antibiotic prophylaxis
|
Drug: Antibiotic
the individual will receive 1 dose of antibiotic during anesthetic induction
|
| Placebo Comparator: placebo
|
Other: placebo
the individual will receive 10 ml of saline during anesthetic induction
|
Outcome Measures
Primary Outcome Measures
- Surgical wound infection [30 days]
CDC protocol for surgical wound infection surveillance
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- individuals with clean soft tissue conditions of the upper limb requiring surgery
Exclusion Criteria:
-
abandonment of treatment
-
ASA > 3
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Marcos Felipe Marcatto de Abreu
Investigators
- Principal Investigator: Marcos M de Abreu, MD, University of Campinas, Brazil
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Marcos Felipe Marcatto de Abreu,
Medical Doctor,
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT05990842
Other Study ID Numbers:
- 57490822.9.0000.5404
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marcos Felipe Marcatto de Abreu,
Medical Doctor,
University of Campinas, Brazil
Additional relevant MeSH terms: