ULTRAPREP Used to Perform Skin Antisepsis Outside the Operating Room

A Randomized, Single-blinded Trial to Study the Efficacy, Safety, and Time Saving Using the ULTRAPREP Device With FDA Approved Antisepsis Solution (70% Isopropyl Alcohol and 2% Chlorhexidine) in Preoperative Skin Antisepsis.

Testing ULTRAPREP (consists of a clear bag sealed on one end with the other end enclosing the patients extremity) for safety and efficacy to perform skin antisepsis outside the operating room.

Study Overview

• Status: Completed
• Conditions: Time Saved Performing Skin Antisepsis Process Outside the OR; Antisepsis of Skin Preparation Outside the OR
• Intervention / Treatment: Device: No Intervention; Device: ULTRAPREP

Detailed Description

The purpose of the study is to determine if ULTRAPREP is equal to or better than the conventional methods of preoperative skin antisepsis (the technique of cleansing the skin to help prevent infection) in surgical cases. The study will also help determine if ULTRAPREP will decrease the total amount of time in the operating room. The study will focus on whether or not using ULTRAPREP provides better patient flow and patient safety while improving a surgical staff's workload and workflow. The study includes 2 study arms:

Study Arm #1: the conventional method (or standard of care) will use an accepted skin disinfectant solution with ChloraPrep (70% isopropyl alcohol and 2% chlorhexidine). The solution is "painted" on the patient's skin using a sponge on a stick. The application time is with this method is 3 minutes plus 3 minutes for solution to evaporate. This is a widely-accepted method used in ORs. The preparation process is performed by surgical staff in the OR prior to surgery.

Study Arm #2: using ULTRAPREP bag containing ChloraPrep (70% isopropyl alcohol and 2% chlorhexidine). The bag will be placed on the patient's lower extremity in the holding area. The lower extremity will be scrubbed for 3 minutes. Once the patient is transferred to the OR, the solution will be suctioned out of the bag and the bag removed from the lower extremity to allow the solution to evaporate, this process take 3 minutes. the patient is then draped for surgery.

This study consists of 57 patients in each arm.

Sterile culture swabs will be taken from toenail beds and between toes or from fingernail beds and between fingers, depending on surgery site. The cultures will be taken preoperative before any disinfecting has begun and just before patient extremity is draped (after allowing 3 minutes for alcohol in disinfectant to evaporate). These sterile swabs will be taken to the lab for aliquot culturing to yield 6 pitre dishes for each swab. The CFUs (colony forming units) from each pitre dish will be counted and analyzed at 48 and 72 hours. A comparison will be made using the cultures in Arm 1 and Arm 2 to determine if the parameters of the study has been met.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Westlake, Louisiana, United States, 70669
      • PrepTech, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 or older
• Class 1 clean (as defined by The American College of Surgeons)
• Hand and Feet extremities

Exclusion Criteria:

• Open wounds
• Pregnant
• Emergency surgeries
• Class 2-4 (as defined by The American College of Surgeons)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study Arm 1 Conventional Prep/Control; The preoperative preparation for the control group will use ChloraPrep (2% chlorhexidine and 70% isopropyl alcohol) that will be applied to the skin using a sponge-on-a-stick method; this solution is widely recognized as optimal. After the alcohol-based solution has evaporated (no less than 3 minutes), the patient extremity is draped for surgery.	Device: No Intervention; Conventional skin preparation technique
Other: Study Arm 2 ULTRAPREP Group/Intervention Arm; ChloraPrep (2% chlorhexidine and 70% isopropyl alcohol) will be poured into the ULTRAPREP bag which will be placed on the patient's extremity while in the holding area; it will be removed only after scrub time of 3 minutes is complete and the patient has been transferred to the OR, anesthetized, and positioned. The patient is draped only after the solution has evaporated (no less than 3 minutes).	Device: ULTRAPREP; ULTRAPREP device for reducing OR prep times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Time: Room to drape	Minutes elapsed from patient ready for prep and ready for draping	Up to 60 minutes
Change in Time: ULTRAPREP bag use	Minutes elapsed from ULTRAPREP placed on extremity to scrubbing complete	Up to 60 minutes
Colony forming units (CFU) Pre-Prep 48h	CFUs of bacteria per plate, collected upon arrival to pre-op area, measured after 48 hours growth	48 hours after collection
Colony forming units (CFU) Pre-Prep 72h	CFUs of bacteria per plate, collected upon arrival to pre-op area, measured after 72 hours growth	72 hours after collection
Colony forming units (CFU) Post-Prep 48h	CFUs of bacteria per plate, collected prior to draping, measured after 48 hours growth	48 hours after collection
Colony forming units (CFU) Post-Prep 72h	CFUs of bacteria per plate, collected prior to draping, measured after 72 hours growth	72 hours after collection

Collaborators and Investigators

• Sponsor: Prep Tech, LLC
• Investigators: Study Director: Pete Prados, Business, PrepTech, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2018
• Primary Completion (Actual): January 17, 2019
• Study Completion (Actual): January 17, 2019

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: skin antisepsis; OR efficiency
• Other Study ID Numbers: ULTRAPREP-100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No