ULTRAPREP Used to Perform Skin Antisepsis Outside the Operating Room

Antisepsis of Skin Preparation Outside the OR Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04600310
• Other study ID #: ULTRAPREP-100
• Status: Completed
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: January 17, 2019

Study information

• Verified date: October 2020
• Source: Prep Tech, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: January 17, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Antisepsis of Skin Preparation Outside the OR
• Time Saved Performing Skin Antisepsis Process Outside the OR

Intervention

Device:
• ULTRAPREP
ULTRAPREP device for reducing OR prep times.
• No Intervention
Conventional skin preparation technique

Locations

Country	Name	City	State
United States	PrepTech, LLC	Westlake	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Prep Tech, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Time: Room to drape	Minutes elapsed from patient ready for prep and ready for draping	Up to 60 minutes
Primary	Change in Time: ULTRAPREP bag use	Minutes elapsed from ULTRAPREP placed on extremity to scrubbing complete	Up to 60 minutes
Primary	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
Primary	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
Primary	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
Primary	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