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

NCT01076049 | Terminated Results DMC FDA Device

• 1 other identifier: 108527
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Wound State at 48-Hour Follow-up Visit

  The primary endpoint was overall wound progression and signs of infection 48 hours post-treatment. This was measured via a blinded investigator's discretion and recorded as 'improved', 'no change', 'progression of signs or symptoms of infection', or 'immediate treatment required' if an infection had progressed to a certain extent.

  48 hours

Secondary Outcomes (1)

• Clinical Performance of Irrisept to the Current SoC

  48 hours

Study Arms (2)

Standard of Care (SoC)

ACTIVE COMPARATOR

For subjects randomized to the control group, the preferred irrigation solution was chosen by the site's emergency department physician(s).

Device: Standard of Care (SoC)

Irrisept

ACTIVE COMPARATOR

For subjects randomized to the investigational group, Irrisept was used.

Device: Irrisept Delivery System

Interventions

Standard of Care (SoC) DEVICE

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.

Standard of Care (SoC)

Irrisept Delivery System DEVICE

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.

Also known as: Irrisept

Irrisept

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80
• Skin and soft tissue infections (SSTIs), in the form of an abscess, which will require incision and drainage.
• Patient able to provide an informed consent.
• Patient volunteers to participate.

You may not qualify if:

• Wound was caused by human or animal bite.
• Wound is a blunt crush injury or has tendon, bone, or joint involvement.
• Diabetic foot infection.
• Anticipated incision size less than 5mm.
• Abscess extends to the muscle layer.
• Admission to hospital for any reason, including IV antibiotics.
• Clinical signs of systemic infection on initial patient encounter.
• Prior history of allergy or hypersensitivity to CHG.
• Neutropenic (known ANC\<500/mm3), HIV (known CD4\<50), or other severely immunocompromised state (e.g., receiving chemotherapy).
• Patient is diagnosed with systemic lupus erythematosus or other immunological disease.
• Currently in police custody.
• Patient withdraws from participation.
• Patient unable or unwilling to give informed consent.

Sponsors & Collaborators

• Irrimax Corporation: lead

Study Sites (1)

Tampa General Hospital - University of South Florida

Tampa, Florida, 33606, United States

Location

MeSH Terms

Conditions

Soft Tissue Infections; Abscess

Condition Hierarchy (Ancestors)

Infections; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chevy Brown, Clinical Trials Manager
• Organization: Irrimax Corporation

chevy.brown@irrisept.com

770-807-3355

Study Officials

• David Wein, MD

  Tampa General Hospital, University South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The randomization methodology was controlled by a biostatistician at the site.

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 25, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 23, 2021
• Results First Posted: July 28, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)