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

NCT ID: NCT01076049

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-12-31

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.

Detailed Description

After being informed about the trial and potential risks, subjects completed an informed consent form prior to participation. After eligibility criteria was verified, an initial wound assessment examination was performed. Subjects were then randomized to the Irrisept or Standard of Care treatment group. Forty-eight hours later, wound progression and signs of infection were assessed.

Conditions

Skin and Soft Tissue Infections; Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard of Care (SoC)

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

Group Type: ACTIVE_COMPARATOR

Standard of Care (SoC)

Intervention Type: 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.

Irrisept

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

Group Type: ACTIVE_COMPARATOR

Irrisept Delivery System

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Irrisept

Eligibility Criteria

Inclusion Criteria

1. Age 18 to 80

2. Skin and soft tissue infections (SSTIs), in the form of an abscess, which will require incision and drainage.

3. Patient able to provide an informed consent.

4. Patient volunteers to participate.

Exclusion Criteria

1. Wound was caused by human or animal bite.

2. Wound is a blunt crush injury or has tendon, bone, or joint involvement.

3. Diabetic foot infection.

4. Anticipated incision size less than 5mm.

5. Abscess extends to the muscle layer.

6. Admission to hospital for any reason, including IV antibiotics.

7. Clinical signs of systemic infection on initial patient encounter.

8. Prior history of allergy or hypersensitivity to CHG.

9. Neutropenic (known ANC<500/mm3), HIV (known CD4<50), or other severely immunocompromised state (e.g., receiving chemotherapy).

10. Patient is diagnosed with systemic lupus erythematosus or other immunological disease.

11. Currently in police custody.

12. Patient withdraws from participation.

13. Patient unable or unwilling to give informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Irrimax Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Wein, MD

Role: PRINCIPAL_INVESTIGATOR

Tampa General Hospital, University South Florida

Locations

Tampa General Hospital - University of South Florida

Tampa, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

108527

Identifier Type: -

Identifier Source: org_study_id