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

Skin Cancer Clinical Trial

— TISMIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04413383
• Other study ID #: 2023744
• Status: Completed
• Phase: N/A
• Start date: December 21, 2020
• Est. completion date: July 14, 2021

Study information

• Verified date: August 2021
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: July 14, 2021
• Est. primary completion date: July 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Skin Cancer
• Skin Neoplasms

Intervention

Other:
• Traditional Curved Iris Scissors
Aesculap Curved Iris Scissors
• Wuennenberg Modified Curved Iris Scissors
Modified Silent Curved Iris Scissors
• Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors
Patients experience both types of scissors

Locations

Country	Name	City	State
United States	UPMB	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)