"Enhancing Surgical Safety in Developing Nations: Investi... | NCT05990842

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

NCT05990842

Sponsor

Marcos Felipe Marcatto de Abreu

Status

Unknown status

Last Update Posted

Aug 14, 2023Actual

Enrollment

51Estimated

Phase

Not Applicable

Conditions

Soft Tissue Injuries

Interventions

Antibiotic
placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2023Estimated

Primary Completion Date

Aug 8, 2025Estimated

Completion Date

Sep 8, 2025Estimated

First Submitted Date

Aug 6, 2023

First Submission Date that Met QC Criteria

Aug 6, 2023

First Posted Date

Aug 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2023

Last Update Posted Date

Aug 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marcos Felipe Marcatto de Abreu, Medical Doctor, University of Campinas, BrazilSponsor-Investigator

Lead Sponsor

Marcos Felipe Marcatto de AbreuOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
antibiotic prophylaxis	Experimental		Drug: Antibiotic
placebo	Placebo Comparator		Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antibiotic	Drug	the individual will receive 1 dose of antibiotic during anesthetic induction	antibiotic prophylaxis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgical wound infection	CDC protocol for surgical wound infection surveillance	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

abandonment of treatment
ASA > 3

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marcos M Abreu, MD	Contact	+55 19 3521-7512		marcatto@unicamp.br

Overall Officials

Name	Affiliation	Role
Marcos M de Abreu, MD	University of Campinas, Brazil	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42139662	Derived	Marcatto-Abreu MF, de Magalhaes Tenorio PH, Etchebehere M. Surgical antibiotic prophylaxis in clean elective upper limb soft-tissue surgery in a resource-limited setting: a randomized, double-blind, placebo-controlled trial. Expert Rev Anti Infect Ther. 2026 May;24(5):465-473. doi: 10.1080/14787210.2026.2672549. Epub 2026 May 18.

ID	Term
D017695	Soft Tissue Injuries
D013530	Surgical Wound Infection

ID	Term
D014947	Wounds and Injuries
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications

ID	Term
D000890	Anti-Infective Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses