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

NCT ID: NCT04413383

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-21

Study Completion Date

2021-07-14

Brief Summary

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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.

Detailed Description

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Conditions

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Skin Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Traditional Curved Iris Scissors

Intervention Type OTHER

Aesculap Curved Iris Scissors

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.

Group Type EXPERIMENTAL

Wuennenberg Modified Curved Iris Scissors

Intervention Type OTHER

Modified Silent Curved Iris Scissors

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.

Group Type OTHER

Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors

Intervention Type OTHER

Patients experience both types of scissors

Interventions

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Traditional Curved Iris Scissors

Aesculap Curved Iris Scissors

Intervention Type OTHER

Wuennenberg Modified Curved Iris Scissors

Modified Silent Curved Iris Scissors

Intervention Type OTHER

Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors

Patients experience both types of scissors

Intervention Type OTHER

Other Intervention Names

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Curved Iris Scissors Modified Curved Iris Scissors Comparative Experience

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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John Wuennenberg

Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John P Wuennenberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia Dermatology

Locations

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UPMB

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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2023744

Identifier Type: -

Identifier Source: org_study_id

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