Postoperative interstitial high-dose-rate (HDR) brachytherapy in the treatment of therapy-resistant keloids. Long-term results of AMC cohort

Postoperative interstitial high-dose-rate (HDR) brachytherapy in the treatment of therapy-resistant keloids. Long-term results of AMC cohort - Postoperative brachytherapy for keloids. Outcomes AMC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42479

Enrollment

Registered

2015-10-26

Start date

2015-12-10

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keloid scar-benign-tumour

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients treated with excision and adjuvant brachytherapy for a keloid at the Academic Medical Center between July 2007 and October 2014. The cohort consist of 60 patients with 70 keloids

Exclusion criteria

Exclusion criteria: Inability or unwillingness of the patient to provide informed consent or legally incompetent/incapacitated to do so

Design outcomes

Primary

Measure	Time frame
7.TREATMENT / INTERVENTION For every keloid a data distraction form will be filled in (see appendix I). It includes patient and keloid characteristics, which will be extracted from the patients* records. The outcome measurements will be evaluated at the moment of the assessment consultation. 8.METHODS 8.1.Study procedure All consecutive keloids treated with excision followed by HDR brachytherapy at the AMC are subject of inclusion, thus 60 consecutive patients with a follow up longer than 12 months. Patients will be invited to undergo a clinical assessment at the plastic and reconstructive surgery outpatient clinic. This will be done by means of an invitation letter. No extra imaging, blood test or other intervention will be performed. During this interview, for every keloid, a distraction data form (Appendix I) will be filled in. It includes patient characteristics, keloid characteristics en outcome measurements. In case the patients are unable to come but willing to participate in the study they can do it in the form of a call interview. In the informed consent form, the patient can fill in a desired date and time frame for the call interview. During the call interview the required information for items E and F of the distraction form will be collected by asking the patient. During the first month of the project all the clinical assessments will be performed. During the second month the information will be analysed. The results of the study will be presented at national and international meetings and submitted as a paper for a peer reviewed scientific medical journal. 8.2.Study parameters/endpoints The first end-point will be the recurrence rate defined as a growing, pruritic, nodular scar.[11] A subjective scar evaluation will be performed by the patient and an independent medical doctor using the validated Patient and Observer Scar Assessment Scale (POSAS) as a descriptive measure to record the postoperative scar (Appendix II).	—

Measure

Time frame

7.TREATMENT / INTERVENTION For every keloid a data distraction form will be filled in (see appendix I). It includes patient and keloid characteristics, which will be extracted from the patients* records. The outcome measurements will be evaluated at the moment of the assessment consultation. 8.METHODS 8.1.Study procedure All consecutive keloids treated with excision followed by HDR brachytherapy at the AMC are subject of inclusion, thus 60 consecutive patients with a follow up longer than 12 months. Patients will be invited to undergo a clinical assessment at the plastic and reconstructive surgery outpatient clinic. This will be done by means of an invitation letter. No extra imaging, blood test or other intervention will be performed. During this interview, for every keloid, a distraction data form (Appendix I) will be filled in. It includes patient characteristics, keloid characteristics en outcome measurements. In case the patients are unable to come but willing to participate in the study they can do it in the form of a call interview. In the informed consent form, the patient can fill in a desired date and time frame for the call interview. During the call interview the required information for items E and F of the distraction form will be collected by asking the patient. During the first month of the project all the clinical assessments will be performed. During the second month the information will be analysed. The results of the study will be presented at national and international meetings and submitted as a paper for a peer reviewed scientific medical journal. 8.2.Study parameters/endpoints The first end-point will be the recurrence rate defined as a growing, pruritic, nodular scar.[11] A subjective scar evaluation will be performed by the patient and an independent medical doctor using the validated Patient and Observer Scar Assessment Scale (POSAS) as a descriptive measure to record the postoperative scar (Appendix II).

—

Secondary

Measure	Time frame
The secondary end point will be toxicity [dehiscence of the wound, infection, chronic wound, skin ulceration, hyperpigmentation and hypopigmentation].	—

Countries

Netherlands

Outcome results