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

NCT04413383 | Completed

• 1 other identifier: 2023744
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Cancer

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (3)

Traditional Curved Iris Scissors

ACTIVE COMPARATOR

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

Modified Curved Iris Scissors

EXPERIMENTAL

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

Comparative Experience

OTHER

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

Interventions

Traditional Curved Iris Scissors OTHER

Aesculap Curved Iris Scissors

Also known as: Curved Iris Scissors

Traditional Curved Iris Scissors

Wuennenberg Modified Curved Iris Scissors OTHER

Modified Silent Curved Iris Scissors

Also known as: Modified Curved Iris Scissors

Modified Curved Iris Scissors

Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors OTHER

Patients experience both types of scissors

Also known as: Comparative Experience

Comparative Experience

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

UPMB

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John P Wuennenberg, MD

  University of Missouri-Columbia Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 2, 2020
• Study Start: December 21, 2020
• Primary Completion: July 14, 2021
• Study Completion: July 14, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)