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Floraseal Versus Iodine Impregnated Adhesive Drapes

NCT03466489 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-07-22

No results posted yet for this study

Summary

Infection after total joint arthroplasty can have devastating consequences. Adhesive drapes have been traditionally used at our institution to help reduce the risk of wound contamination and infection by superficial skin flora. Our primary objective is to determine if a cyanoacrylate-based sealant (FloraSeal microbial sealant) is superior to conventional iodine impregnated drapes in prevention of both superficial and deep surgical site infections in total joint arthroplasty (TJA) patients. A prospective, randomized controlled model will be used to answer this question.

Conditions

  • Surgical Site Infection
  • Surgical Wound Infection

Interventions

DEVICE

Floraseal

FloraSeal is a cyanoacrylate-based sealant used in the prevention of surgical site infections.

Sponsors & Collaborators

  • Osteoremedies

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Victor H Hernandez, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-11-01
Completion
2020-02-01
FDA Device
Yes

Countries

  • United States

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 NCT03466489 on ClinicalTrials.gov