NCT05990842

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

August 8, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2025

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

August 6, 2023

Last Update Submit

August 6, 2023

Conditions

Soft Tissue Injuries

Keywords

antibiotic prophylaxishand surgeryorthopedic surgerypostoperative caresurgical wound infectiondeveloping country

Outcome Measures

Primary Outcomes (1)

  • Surgical wound infection

    CDC protocol for surgical wound infection surveillance

    30 days

Study Arms (2)

antibiotic prophylaxis

EXPERIMENTAL
Drug: Antibiotic

placebo

PLACEBO COMPARATOR
Other: placebo

Interventions

AntibioticDRUG

the individual will receive 1 dose of antibiotic during anesthetic induction

antibiotic prophylaxis
placeboOTHER

the individual will receive 10 ml of saline during anesthetic induction

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • abandonment of treatment
  • ASA \> 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Soft Tissue InjuriesSurgical Wound Infection

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Wounds and InjuriesWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Marcos M de Abreu, MD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcos M Abreu, MD

CONTACT

+55 19 3521-7512marcatto@unicamp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 14, 2023

Study Start

August 8, 2023

Primary Completion

August 8, 2025

Study Completion

September 8, 2025

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

all data will be made available, with the exception of the name of the participant

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
30 days after study publication
Access Criteria
peer reviewer of a scientific magazine