Comparison on Radiotherapy Permanent Skin Marking With Lancets and an Electric Marking Device

Radiotherapy Clinical Trial

— COMFORTATTOO  

Official title:

Research Study: Tattooing of Skin Landmarks in Radiotherapy: Comparison Between the System Traditional and Comfort Marker 2.0® (COMFORTATTOO)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05371795
• Other study ID #: CONFORTATTOO
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: September 2022

Study information

• Verified date: June 2022
• Source: Instituto Portugues de Oncologia, Francisco Gentil, Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison on radiotherapy skin set-up markings with lancets versus Comfort Marker 2.0®

Description:

A Prospective, unicentric, randomized, controlled, parallel, double-blinded, cohort study comparing radiotherapy skin set-up markings with lancets versus electric marking device (Comfort Marker 2.0® by CIVCO®)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age at least 18 years old.

• Patients referred to our department to receive external beam radiation therapy.

• Eastern Cooperative Oncology Group performance status of 0 to 1.

• Estimated fractionating schedule of at least 13 once-daily fractions.

• Written informed consent.

Exclusion Criteria:

• Patients requiring either immobilisation thermoplastic masks (for head or head and shoulders) or vacuum cushion.

Related Conditions & MeSH terms

• Radiotherapy
• Tattooing

Intervention

Device:
• Comfort Marker 2.0
The set-up markings are created during the simulation session, after the CT simulation is acquired. For the experimental group, patients' markings are tattooed using an electric marking device developed for set-up marking, the Comfort Marker 2.0® (CM), designed by CIVCO medical solutions, using the 0.2mm deep application depth and the brand-included black pigment. After cleaning the excess ink, if the tattooing was considered unsuccessful, the process was repeated. Markings arrangement followed our departmental protocol. No limit on the maximum number of cutaneous reference points is specified.
• Lancets
The set-up markings are created during the simulation session, after the CT simulation is acquired. For the control group, patients' markings are tattooed using a 28-gauge disposable lancet and india ink. After cleaning the excess ink, if the tattooing was considered unsuccessful, the process was repeated. Markings arrangement followed our departmental protocol. No limit on the maximum number of cutaneous reference points is specified.

Locations

Country	Name	City	State
Portugal	Instituto Português de Oncologia do Porto Francisco Genti	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Portugues de Oncologia, Francisco Gentil, Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tattoo fading	A photographic assessment is performed. Every set-up marking is individually photographed a. All photographs are scored by indepe6 months after completion of the RT. All photographs are scored by independent observers(both physicians and RTTs) blind to patient identity and treatment allocation, on a five-point scale (corresponding from bad to excellent fading).	6 months from the end of irradiation
Primary	Patients' comfort	Comfort is verbally assessed on the 11-point numeric pain scale. As more than one reference point is tattooed, the patients are asked to give an overall score to the procedure.	Day 1
Primary	Effectiveness	Effectiveness is assessed by the RTT team that delivered the daily fractions. Skin markings are individually evaluated at several periods, specifically at the first fraction, then every 5 fractions, and one last time in the last fraction of RT. These evaluations are scored on a 4-point graded scale (corresponding to bad, reasonable, good, and excellent).	up to 7 weeks
Secondary	RTTs' satisfaction	The RTT that executed the tattooing is asked to score the ease of the process on a three-point scale (easy, medium, and hard).	Day 1
Secondary	Cosmesis	A photographic assessment is performed. Every set-up marking is individually photographed on one of the last three days of treatment. All photographs are scored by independent observers (both physicians and RTTs) blind to patient identity and treatment allocation, on a five-point scale (corresponding from bad to excellent cosmesis).	one of the last three days of irradiation