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Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances

NCT04218110 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 329

Last updated 2021-10-22

Study results available
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Summary

Comparative study of antimicrobial effectiveness evaluation of of 26ml Project X, 10.5ml Project X, 5.1ml Project X and Prevantics Maxi swabstick following ASTM E1173 - Standard test method for evaluation of preoperative, precatheterization or preinjection skin preparations.

Conditions

  • Surgical Site Infection

Interventions

DRUG

Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic

Application of antiseptic drug to the inguinal area of the subjects

DRUG

Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic

Application of antiseptic drug to the inguinal area of the subjects

DRUG

Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic

Application of antiseptic drug to the inguinal area of the subjects

DRUG

Prevantics 3.15 % / 70 % Swabstick

Application of antiseptic drug to the inguinal area of the subjects

Sponsors & Collaborators

  • Professional Disposables International, Inc.

    lead INDUSTRY

Principal Investigators

  • Rozalia Olsavszky, MD · EUROFINS EVIC PRODUCT TESTING ROMANIA S.R.L

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-11
Primary Completion
2020-03-10
Completion
2020-03-31
FDA Drug
Yes

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04218110 on ClinicalTrials.gov