ULTRAPREP Used to Perform Skin Antisepsis Outside the Operating Room

NCT04600310 | Completed DMC FDA Device

• 1 other identifier: ULTRAPREP-100
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

skin antisepsis; OR efficiency

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Study Arm 1 Conventional Prep/Control

OTHER

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

Study Arm 2 ULTRAPREP Group/Intervention Arm

OTHER

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

Interventions

ULTRAPREP DEVICE

ULTRAPREP device for reducing OR prep times.

Study Arm 2 ULTRAPREP Group/Intervention Arm

No Intervention DEVICE

Conventional skin preparation technique

Study Arm 1 Conventional Prep/Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Prep Tech, LLC: lead

Study Sites (1)

PrepTech, LLC

Westlake, Louisiana, 70669, United States

Location

Study Officials

• Pete Prados, Business

  PrepTech, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 23, 2020
• Study Start: April 17, 2018
• Primary Completion: January 17, 2019
• Study Completion: January 17, 2019
• Last Updated: October 23, 2020

Record last verified: 2020-10

Locations

US (1)