Soft Tissue InjuriesNCT05990842
"Enhancing Surgical Safety in Developing Nations: Investigating Antibiotics' Role in Hand Surgeries."
A study testing Antibiotic in people with Soft Tissue Injuries, run by Marcos Felipe Marcatto de Abreu.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Injuries
- What is being tested?
- Antibiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 8 Aug 2023to 8 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals with clean soft tissue conditions of the upper limb requiring surgery
Who cannot join
- abandonment of treatment
- ASA > 3
Trial locations and contacts
No sites are listed yet.
About this study
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"
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.
- Conditions
- Soft Tissue Injuries
- Being tested
- Antibiotic, placebo
- Keywords
- antibiotic prophylaxis, hand surgery, orthopedic surgery, postoperative care, surgical wound infection, developing country
- Medical subject headings
- Soft Tissue Injuries, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
the individual will receive 1 dose of antibiotic during anesthetic induction
placeboOther
the individual will receive 10 ml of saline during anesthetic induction
| Study group | Role | What they receive |
|---|---|---|
| antibiotic prophylaxis | Experimental | Not described Receives: Drug: Antibiotic |
| placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical wound infection
CDC protocol for surgical wound infection surveillance
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start8 Aug 2023 (estimated)
- Primary completion8 Aug 2025 (estimated)
- Study completion8 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marcos Felipe Marcatto de Abreu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcos Felipe Marcatto de Abreu, University of Campinas, Brazil
- Investigators
- Marcos M de Abreu, MD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990842
- Sponsor's protocol ID
- 57490822.9.0000.5404
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data will be made available, with the exception of the name of the participant
Publications
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.
PubMed 42139662
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT05990842
- Acronym / sponsor ID
- 57490822.9.0000.5404
- Conditions
- Soft Tissue Injuries
- Keywords
- antibiotic prophylaxis, hand surgery, orthopedic surgery, postoperative care, surgical wound infection, developing country
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Marcos Felipe Marcatto de AbreuUniversity, hospital or other
- Study start
- 8 Aug 2023 (estimated)
- Primary completion
- 8 Aug 2025 (estimated)
- Study completion
- 8 Sep 2025 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antibiotic prophylaxis | Experimental | Drug: Antibiotic |
| placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- individuals with clean soft tissue conditions of the upper limb requiring surgery
Key exclusion criteria (2 listed)
- abandonment of treatment
- ASA > 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibioticthe individual will receive 1 dose of antibiotic during anesthetic induction | Drug | antibiotic prophylaxis |
| placebothe individual will receive 10 ml of saline during anesthetic induction | Other | placebo |
Primary outcome
Surgical wound infection
Time frame: 30 days
CDC protocol for surgical wound infection surveillance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 42139662Marcatto-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.
- Individual participant dataSharing planned: Yes. all data will be made available, with the exception of the name of the participant
Related trials for Soft Tissue Injuries
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcos M de Abreu, MD principal investigator
University of Campinas, Brazil
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic in people with Soft Tissue Injuries, run by Marcos Felipe Marcatto de Abreu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcos M Abreu, MD (+55 19 3521-7512, marcatto@unicamp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical wound infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05990842, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.