Skin CancerTISMISNCT04413383
Use of Traditional Curved Iris Scissors or the Wuennenberg Modified Curved Iris Scissors for Skin Surgery
A study testing Traditional Curved Iris Scissors, Wuennenberg Modified Curved Iris Scissors and Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors in people with Skin Cancer, run by University of Missouri-Columbia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Traditional Curved Iris Scissors, Wuennenberg Modified Curved Iris Scissors and Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2020to 14 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (18 years or older)
- non-pregnant
- patients being treated with Mohs micrographic surgery or excision on the head and neck
Who cannot join
- Patients not meeting above inclusion criteria will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Skin Cancer
- Being tested
- Traditional Curved Iris Scissors, Wuennenberg Modified Curved Iris Scissors, Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Curved Iris ScissorsOther
Also called Curved Iris Scissors
Aesculap Curved Iris Scissors
Wuennenberg Modified Curved Iris ScissorsOther
Also called Modified Curved Iris Scissors
Modified Silent Curved Iris Scissors
Comparative Experience of Traditional and Wuennenberg Modified Curved Iris ScissorsOther
Also called Comparative Experience
Patients experience both types of scissors
| Study group | Role | What they receive |
|---|---|---|
| Traditional Curved Iris Scissors | Active comparator | 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. Receives: Other: Traditional Curved Iris Scissors |
| Modified Curved Iris Scissors | Experimental | 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. Receives: Other: Wuennenberg Modified Curved Iris Scissors |
| Comparative Experience | Other | 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. Receives: Other: Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 to 8 hours (length of the patients Mohs Surgery)
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.
Measured: 3 to 8 hours (length of the patients Mohs Surgery)
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.
Measured: 3 to 8 hours (length of the patients Mohs Surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start21 Dec 2020
- Primary completion14 Jul 2021
- Study completion14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Wuennenberg, University of Missouri-Columbia
- Investigators
- John P Wuennenberg, MD, Principal investigator, University of Missouri-Columbia Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413383
- Sponsor's protocol ID
- 2023744
- Acronym
- TISMIS
- Status last verified
- Aug 2021
- First submitted
- 19 May 2020
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Patients Undergoing Dermatologic Surgery Prefer the Use of Traditional Curved Iris Scissors or the Wuennenberg Modified Curved Iris Scissors?
- ClinicalTrials.gov ID
- NCT04413383
- Acronym / sponsor ID
- TISMIS / 2023744
- Conditions
- Skin Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional Curved Iris Scissors | Active comparator | Other: Traditional Curved Iris ScissorsThe 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. |
| Modified Curved Iris Scissors | Experimental | Other: Wuennenberg Modified Curved Iris ScissorsThe 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. |
| Comparative Experience | Other | Other: Comparative Experience of Traditional and Wuennenberg Modified Curved Iris ScissorsBoth 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (18 years or older)
- non-pregnant
- patients being treated with Mohs micrographic surgery or excision on the head and neck
Key exclusion criteria (1 listed)
- Patients not meeting above inclusion criteria will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Curved Iris ScissorsAlso: Curved Iris ScissorsAesculap Curved Iris Scissors | Other | Traditional Curved Iris Scissors |
| Wuennenberg Modified Curved Iris ScissorsAlso: Modified Curved Iris ScissorsModified Silent Curved Iris Scissors | Other | Modified Curved Iris Scissors |
| Comparative Experience of Traditional and Wuennenberg Modified Curved Iris ScissorsAlso: Comparative ExperiencePatients experience both types of scissors | Other | Comparative Experience |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P Wuennenberg, MD principal investigator
University of Missouri-Columbia Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Curved Iris Scissors, Wuennenberg Modified Curved Iris Scissors and Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors in people with Skin Cancer, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent that patient notices curved Iris scissors (time frame: 3 to 8 hours (length of the patients Mohs Surgery)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.