Clinical Trial: IrrSept vs. Standard of Care in Prevention of Surgical Site Infections

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase IV, Multicenter, Prospective, Randomized, Controlled Clinical Study to Compare the IrriSept System Versus Standard of Care on the Prevalence of Surgical Site Infection in Patients With

Brief Summary: This is a Phase IV study designed to evaluate rate of Surgical Site Infections (SSIs) when the IrriSept device is used in an open abdominal laparotomy for abdominal trauma or acute surgical abdomen. Half of the eligible subjects will be randomized to receive the IrriSept device and half of the subjects will receive the respective institution's Standard of Care (SoC).

Detailed Summary:

IRR-CT-901-2013-01 is a Phase IV, multi-center, prospective, randomized, controlled, comparator clinical trial. The study consists of 3 parts: a Screening Phase typically performed in the Emergency Department, a randomized, open-label Treatment (Perioperative) Phase, and End of Study, a 30-day Follow-up.

Medical Centers throughout the United States will participate as research sites, enrolling eligible subjects 18 years of age and older who undergo open abdominal laparotomy for abdominal trauma or acute surgical abdomen. Subjects will be randomized in a 1 - 1 ratio to receive the IrriSept irrigation device or the institution's Standard of Care (SoC) prior to abdominal surgery.

Exclusion criteria includes: known allergy to chlorhexidine gluconate (CHG), Abbreviated Injury Scale (AIS) score of six (6), American Society of Anesthesiologists Physical Status Classification (ASA) score of five (5) or greater, female subjects who are pregnant and/or breast feeding, those patients undergoing a damage control laparotomy, abdominal incision created prior to operating room, and patients enrolled in a concurrent, ongoing interventional, randomized clinical trial.

Patient risk factors assessed at screening include chronic uncontrolled hypertension, chronic heart disease, chronic renal disease, chronic pulmonary disease, diabetes mellitus, HIV, chronic liver disease, a BMI of less than 18 or above 40, coagulopathy, current long-term steroid use, current smoker, and current cancer. Additional assessments include PATI (Penetrating Abdominal Trauma Index), AIS and ASA scores, and adherence to SCIP prophylactic antibiotic-specific guidelines. Other measures to be documented will include antibiotic usage and surgical skin preparation. The following "present on admission" (PoA) chara
Sponsor: Irrimax Corporation

Current Primary Outcome: Rate of surgical site infections (SSI) [ Time Frame: 30 days post surgical procedure ]

Compare the rate of SSI in the IrriSept system randomization group to the rate of SSI in Standard of Care randomization group.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hospital readmission rates [ Time Frame: 30 days post surgical procedure ]
    Compare the hospital readmission rate of subjects receiving the IrriSept system to the hospital readmission rate of subjects receiving Standard of Care treatment.
  • Hospital costs [ Time Frame: 30 days post surgical procedure ]
    Compare the estimated hospital cost to charge ratio between the IrriSept system and Standard of Care.
  • Length of hospital stay [ Time Frame: 30 days post surgical procedure ]
    Compare the length of hospital stay between IrriSept system and Standard of Care.


Original Secondary Outcome: Same as current

Information By: Irrimax Corporation

Dates:
Date Received: September 30, 2014
Date Started: January 2015
Date Completion: May 2017
Last Updated: December 12, 2016
Last Verified: December 2016