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OpenTrials
Completed

NCT Number: NCT04413383

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMB

Columbia, Missouri, 65212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional Curved Iris Scissors

Other

Aesculap Curved Iris Scissors

Other names: Curved Iris Scissors

Wuennenberg Modified Curved Iris Scissors

Other

Modified Silent Curved Iris Scissors

Other names: Modified Curved Iris Scissors

Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors

Other

Patients experience both types of scissors

Other names: Comparative Experience

Primary outcomes

  1. 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.

  2. 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. 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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

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

Acronym: TISMIS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2020
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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