Use of Traditional Curved Iris Scissors or the Wuennenberg Modified Curved Iris Scissors for Skin Surgery (TISMIS)

Do Patients Undergoing Dermatologic Surgery Prefer the Use of Traditional Curved Iris Scissors or the Wuennenberg Modified Curved Iris Scissors?

Every year thousands of dermatologic surgery procedures are performed at the University of Missouri Department of Dermatology, including Mohs Micrographic Surgery (MMS), Excisions, and biopsies. Surgery is known to cause anxiety for patients and with these procedures performed under local anesthetic on awake patients', the sights, sounds, and smells experienced during the procedure can lead to an increase in their anxiety or affect their overall perception of the experience. From performing and assisting with dermatologic surgery the noise associated with the use of the traditional curved Iris scissors provokes an increase in patient awareness to the procedure resulting in increased anxiety, triggering of the vasovagal response, and expressions of annoyance by the patient. However, the modified curved Iris scissors make almost no noise. The Investigators hypothesize that if patients were given the comparative experience of both types of curved Iris scissors during dermatologic surgery, then they will choose the modified curved Iris scissors because the lack of noise will be perceived as more pleasant experience. Our objective is to perform a prospective, single blinded, randomized controlled trial to determine how the noise of traditional curved Iris scissors vs the silent Wuennenberg modified curved Iris scissors affects patients during dermatologic surgery.

Study Overview

• Status: Completed
• Conditions: Skin Cancer
• Intervention / Treatment: Other: Traditional Curved Iris Scissors; Other: Wuennenberg Modified Curved Iris Scissors; Other: Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • UPMB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult (18 years or older)
• non-pregnant
• patients being treated with Mohs micrographic surgery or excision on the head and neck

Exclusion Criteria:

• Patients not meeting above inclusion criteria will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Traditional Curved Iris Scissors; The traditional curved Iris scissors are used to during the dermatologic surgery. Patients complete a survey after the surgery on sights, sounds and smells experienced during the procedure.	Other: Traditional Curved Iris Scissors; Aesculap Curved Iris Scissors; Other Names: Curved Iris Scissors
EXPERIMENTAL: Modified Curved Iris Scissors; The Wuennenberg modified curved Iris scissors are used during the dermatologic surgery. Patients complete a survey after the surgery on sights, sounds and smells experienced during the procedure.	Other: Wuennenberg Modified Curved Iris Scissors; Modified Silent Curved Iris Scissors; Other Names: Modified Curved Iris Scissors
OTHER: Comparative Experience; Both the traditional and modified curved Iris scissors are used and patients are asked which they prefer. Patients complete a survey after the surgery on sights, sounds and smells experienced during the procedure.	Other: Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors; Patients experience both types of scissors; Other Names: Comparative Experience

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent that patient notices curved Iris scissors	Questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient notices the use of the curved iris scissors.	3 to 8 hours (length of the patients Mohs Surgery)
Extent that patient is bothered by the curved Iris scissors	Questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient is bothered by the curved iris scissors.	3 to 8 hours (length of the patients Mohs Surgery)
Patients Preference of curved Iris scissor	Patient is asked during the procedure if they prefer "1," surgeon uses the traditional curved Iris scissors, or "2" and the surgeon uses the Wuennenberg modified curved Iris scissors. The patient indicates their preference by responding "1 or 2." After the procedure the patient completes a questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient notices and is bothered by the curved iris scissors.	3 to 8 hours (length of the patients Mohs Surgery)

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: John P Wuennenberg, MD, University of Missouri-Columbia Dermatology

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 21, 2020
• Primary Completion (ACTUAL): July 14, 2021
• Study Completion (ACTUAL): July 14, 2021

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (ACTUAL): June 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: 2023744

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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