NCT05371795

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Instituto Portugues de Oncologia, Francisco Gentil, Porto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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®)

Conditions

• Radiotherapy
• Tattooing

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2021-10-18
• Primary completion: 2022-03-11
• Completion: 2022-09-01
• First posted: 2022-05-12
• Last updated: 2022-06-10

Locations

1 site across 1 country: Portugal