search
Back to results

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

Primary Purpose

Skin Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional Curved Iris Scissors
Wuennenberg Modified Curved Iris Scissors
Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Skin Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UPMB

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Other

Arm Label

Traditional Curved Iris Scissors

Modified Curved Iris Scissors

Comparative Experience

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 19, 2020
Last Updated
August 13, 2021
Sponsor
University of Missouri-Columbia
search

1. Study Identification

Unique Protocol Identification Number
NCT04413383
Brief Title
Use of Traditional Curved Iris Scissors or the Wuennenberg Modified Curved Iris Scissors for Skin Surgery
Acronym
TISMIS
Official Title
Do Patients Undergoing Dermatologic Surgery Prefer the Use of Traditional Curved Iris Scissors or the Wuennenberg Modified Curved Iris Scissors?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 21, 2020 (Actual)
Primary Completion Date
July 14, 2021 (Actual)
Study Completion Date
July 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Curved Iris Scissors
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Modified Curved Iris Scissors
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparative Experience
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional Curved Iris Scissors
Other Intervention Name(s)
Curved Iris Scissors
Intervention Description
Aesculap Curved Iris Scissors
Intervention Type
Other
Intervention Name(s)
Wuennenberg Modified Curved Iris Scissors
Other Intervention Name(s)
Modified Curved Iris Scissors
Intervention Description
Modified Silent Curved Iris Scissors
Intervention Type
Other
Intervention Name(s)
Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors
Other Intervention Name(s)
Comparative Experience
Intervention Description
Patients experience both types of scissors
Primary Outcome Measure Information:
Title
Extent that patient notices curved Iris scissors
Description
Questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient notices the use of the curved iris scissors.
Time Frame
3 to 8 hours (length of the patients Mohs Surgery)
Title
Extent that patient is bothered by the curved Iris scissors
Description
Questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient is bothered by the curved iris scissors.
Time Frame
3 to 8 hours (length of the patients Mohs Surgery)
Title
Patients Preference of curved Iris scissor
Description
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.
Time Frame
3 to 8 hours (length of the patients Mohs Surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Wuennenberg, MD
Organizational Affiliation
University of Missouri-Columbia Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMB
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs