NCT01076049

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

Evaluation of a Novel Solution, IrriSept, a New Delivery System, Containing a Long-acting Antimicrobial Agent for Irrigation of Skin and Soft Tissue Infections, in the Form of an Abscess in the Emergency Department: a Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Irrimax Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-02-25
• Last updated: 2021-08-23
• Results posted: 2021-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study