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

NCT ID: NCT05371795

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-18
• Study Completion Date: 2022-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Lancets

Group Type: ACTIVE_COMPARATOR

Lancets

Intervention Type: DEVICE

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.

Comfort Marker 2.0

Group Type: EXPERIMENTAL

Comfort Marker 2.0

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Portugues de Oncologia, Francisco Gentil, Porto

OTHER

Sponsor Role: lead

Responsible Party

André Miranda Pires

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto Português de Oncologia do Porto Francisco Genti

Porto, , Portugal

Countries

Portugal

References

Pires AM, Carvalho L, Santos AC, Vilaca AM, Coelho AR, Oliveira C, Costa C, Fernandes F, Moreira L, Lima J, Vieira R, Ferraz MJ, Silva M, Silva P, Matias R, Zorro S, Costa S, Sarandao S, Barros AF. Radiation Therapy Skin Marking with Lancets Versus Electric Marking Pen (COMFORTATTOO)-6 Months Results on Cosmesis, Fading, and Patients' Satisfaction From a Randomized, Double-Blind Trial. Adv Radiat Oncol. 2023 Nov 5;9(3):101404. doi: 10.1016/j.adro.2023.101404. eCollection 2024 Mar.

Reference Type: DERIVED

PMID: 38292889 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

CONFORTATTOO

Identifier Type: -

Identifier Source: org_study_id