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Clinical Assessment of Next Science Solution on Gustilo and Anderson Type II and IIIA or IIIB Tibial Fractures

NCT04906642 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-11-03

No results posted yet for this study

Summary

This is a prospective, randomized, controlled, double-blinded clinical feasibility study of subjects that are being treated for Gustilo and Anderson Type II or IIIA or IIIB Tibial Fractures

Conditions

  • Surgical Wound Infection

Interventions

DEVICE

Next Science

Solution is a clear, colorless, aqueous solution that is used to remove debris, including microorganisms, from wounds via hydrodynamic shear across the wound. This aids in the removal of foreign material such as, microorganisms, dirt, and debris.

OTHER

Standard of Care

Normal Saline will be used in place of Next Science for irrigation

Sponsors & Collaborators

  • Piedmont Healthcare

    collaborator OTHER

  • Hughston Clinic

    collaborator OTHER

  • Next Science TM

    lead INDUSTRY

Principal Investigators

  • Robert Harris, MD · Piedmont Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-04
Primary Completion
2023-07-05
Completion
2023-09-01
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 NCT04906642 on ClinicalTrials.gov