NCT04957732

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

The Effect of Wound Irrigation With Irrisept Delivery System on Abscess Healing in Patients Presenting to the Emergency Department

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Irrimax Corporation · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

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. At intervals of 48 hours (up to 96 hours) later, abscesses were assessed until healing occurred. If the subject required antibiotics, this was recorded, as well as results from the wound and Methicillin-resistant Staphylococcus Aureus (MRSA) cultures.

Conditions

• Abscess

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2021-07-12
• Last updated: 2022-02-02
• Results posted: 2022-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study