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The Effect of Wound Irrigation With Irrisept on Abscess Healing (Irrisept UF Study)

NCT04957732 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-02-02

Study results available
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Summary

The purpose of this study was to evaluate the safety and effectiveness of Irrisept compared to standard of care treatment of skin and soft tissue infections in the form of abscesses.

Conditions

Interventions

DEVICE

Standard of Care (SoC)

SoC consisted of irrigation with normal saline, using the same proprietary abscess irrigation tip as the Irrisept arm. SoC was used at the initial visit and at each subsequent 48-hour visit interval (up to 96 hours) until abscess healing.

DEVICE

Irrisept Delivery System

Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression. The device had an option for use with an Irriprobe applicator or an abscess irrigation tip. Irrisept was used at the initial visit and at each subsequent 48-hour visit interval (up to 96 hours) until abscess healing.

Sponsors & Collaborators

  • Irrimax Corporation

    lead INDUSTRY

Principal Investigators

  • Richard Petrik, MD · University of Florida/Shands Emergency Department

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-11-30
Completion
2011-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04957732 on ClinicalTrials.gov