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

August 13, 2021 updated by: John Wuennenberg, University of Missouri-Columbia

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
147

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Extent that patient notices curved Iris scissors
Time Frame: 3 to 8 hours (length of the patients Mohs Surgery)
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
Time Frame: 3 to 8 hours (length of the patients Mohs Surgery)
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
Time Frame: 3 to 8 hours (length of the patients Mohs Surgery)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John P Wuennenberg, MD, University of Missouri-Columbia Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 14, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 14, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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