ULTRAPREP Used to Perform Skin Antisepsis Outside the Operating Room

NCT ID: NCT04600310

Last Updated: 2020-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-17
• Study Completion Date: 2019-01-17

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

No Intervention

Intervention Type: DEVICE

Conventional skin preparation technique

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).

Group Type: OTHER

ULTRAPREP

Intervention Type: DEVICE

ULTRAPREP device for reducing OR prep times.

Interventions

ULTRAPREP

ULTRAPREP device for reducing OR prep times.

Intervention Type: DEVICE

No Intervention

Conventional skin preparation technique

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prep Tech, LLC

OTHER

Sponsor Role: lead

Responsible Party

Mallory M. Przybylski, DPM, MSc

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pete Prados, Business

Role: STUDY_DIRECTOR

PrepTech, LLC

Locations

PrepTech, LLC

Westlake, Louisiana, United States

Countries

United States

Other Identifiers

ULTRAPREP-100

Identifier Type: -

Identifier Source: org_study_id