CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 87 enrolled
Drug / intervention
Antibiotic local prophylaxis with medicated calcium sulfate beads +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03976466
NCT03976466Phase 4Completed
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Application of Antibiotic Loaded Calcium Sulfate as Prophylaxis for Patients With Non Modifiable Risk Factors for Periprosthetic Joint Infections

Hospital Regional Tlalnepantla·interventional·Posted Jun 6, 2019·Updated Aug 20, 2020

In Brief

A Phase 4 clinical trial evaluating Antibiotic local prophylaxis with medicated calcium sulfate beads and Classical parenteral antibiotic prophylaxis for Infection. Completed, enrolled 87 participants across 1 site.

Detailed Summary

To demonstrate the prophylactic effect of calcium sulfate beads loaded with antibiotic in patients with non-modifiable risk factors that will undergo a hip or knee joint replacement, comparing with a control group. To know the economic cost generated in antibiotic prophylaxis with calcium sulfate beads in patients undergoing hip or knee joint replacement with non-modifiable risk factors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfection
CountriesMexico
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedJun 6, 2019
Enrollment StartMay 22, 2019
Primary CompletionApr 22, 2020
Study CompletionJul 15, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.1 years ago

Interventions

Antibiotic local prophylaxis with medicated calcium sulfate beadsdevice

Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection

Classical parenteral antibiotic prophylaxisprocedure

Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection