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The Effect of Irrisept for Irrigation of Skin and Soft Tissue Infections (Irrisept USF Study)

NCT01076049 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2021-08-23

Study results available
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Summary

The purpose of this study was to determine whether Irrisept can effectively prevent the progression of skin and soft tissue infections (SSTIs) as compared to treatment by the current Standard of Care.

Conditions

  • Skin and Soft Tissue Infections
  • Abscess

Interventions

DEVICE

Standard of Care (SoC)

The preferred irrigation solution and method was chosen by the site's emergency department physician(s) and could vary between subjects. The type of SoC was recorded in the source document and the same solution and irrigation method were used during the initial treatment and 48-hour follow-up visits.

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. Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits.

Sponsors & Collaborators

  • Irrimax Corporation

    lead INDUSTRY

Principal Investigators

  • David Wein, MD · Tampa General Hospital, University South Florida

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-12-31
Completion
2011-12-31
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 NCT01076049 on ClinicalTrials.gov