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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05990842
Enrollment
51
Registered
2023-08-14
Start date
2023-08-08
Completion date
2025-09-08
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Soft Tissue Injuries

Keywords

antibiotic prophylaxis, hand surgery, orthopedic surgery, postoperative care, surgical wound infection, developing country

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.

Interventions

DRUGAntibiotic

the individual will receive 1 dose of antibiotic during anesthetic induction

OTHERplacebo

the individual will receive 10 ml of saline during anesthetic induction

Sponsors

Marcos Felipe Marcatto de Abreu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* abandonment of treatment * ASA \> 3

Design outcomes

Primary

MeasureTime frameDescription
Surgical wound infection30 daysCDC protocol for surgical wound infection surveillance

Contacts

Primary ContactMarcos M Abreu, MD
marcatto@unicamp.br+55 19 3521-7512

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 17, 2026