4.OBJECTIVETo analyse the outcomes, results and complications, of the keloid treatment with excision followed by immediate adjuvant HDR brachytherapy at the AMC between July 2007 and October 2014.
ID
Source
Brief title
Condition
- Cutaneous neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
The secondary end point will be toxicity [dehiscence of the wound, infection,
chronic wound, skin ulceration, hyperpigmentation and hypopigmentation].
8.3.Withdrawal of individual subjects
Patients can leave the study at any time for any reason if they wish to do so
without any consequences. The investigator can decide to withdraw a patient
from the study for urgent medical reasons.
Secondary outcome
The secondary end point will be toxicity [dehiscence of the wound, infection,
chronic wound, skin ulceration, hyperpigmentation and hypopigmentation].
Background summary
3.INTRODUCTION AND RATIONALE
Keloids are benign fibrous dermal tumours characterized by excessive deposition
of extracellular matrix due to excessive collagen synthesis and decreased
collagen degradation [1], extending often beyond the site of the initial
injury. [2] It impairs the quality of life of patients due to pruritus, aching,
itching and cosmetic disfigurement. [3] Hypertrophic scars on the contrary do
not extend outside the wound area [2,4] and after a few months they tend to
regress without further treatment. [4]The incidence of keloids is hard to
determine, although it is known that in Black and Hispanic people it lies
between 4.5% and 16% with peaks during puberty and pregnancy. [5] In 50-80% of
the keloids excision alone results in recurrence [6], being an elevation of the
scar outside the initial wound. [7] This high recurrence rate has led to
several therapy options, such as interferon [1], pressure therapy, surgery,
laser therapy, cryotherapy, intralesional corticosteroid injection,
5FU-injections, topical imiquimod [8], radiotherapy or a combination of these
therapies. [9] The combination of surgery and immediate postoperative
radiotherapy is considered the most effective for severe therapy-resistant
keloids. [10] Though this combination has been used for nearly a century [1],
the optimal radiation scheme and the way of administering this radiation,
either external beam radiotherapy or brachytherapy, is still unknown. [6]
A dose-effect relationship for keloids with the biologically effective dose
(BED) as dose unit has been reported. [6] The optimal treatment is probably an
irradiation scheme resulting in a BED value of at least 30Gy which can be
obtained with, for instance, a single acute dose of 13 Gy, two fractions of 8
Gy or three fractions of 6 Gy [with High-Dose-Rate (HDR)] or a single dose of
27 Gy at Low-Dose-Rate. The radiation treatment should be administered within 2
days after surgery.
In 2007 the results of adjuvant treatment based on external beam radiotherapy
of the AMC cohort were reported .[4] Patients received 12Gy in 3-4 fractions
with superficial 250-kV electron beam irradiation prescribed at a 25- or 50-cm
source-to-skin distance using a 1-mm copper filter, starting within 24 hours
after surgical excision. Unfortunately, the results were disappointing with a
higher rate of recurrence in comparison to the literature partly being
explained by the long follow-up and the strict inclusion criteria.
Since then at the Academic Medical Center (AMC) in Amsterdam the adjuvant
treatment after excision of therapy-resistant keloids includes the use of HDR
brachytherapy which permits to increase the BED and allows to administer the
dose in one single fraction, with a prescribed dose of 13Gy at 4-7mm from the
source, within the 2 hours after extralesional excision of the keloid.
In 2012 we reported the preliminary long term results based on a retrospective
study of 24 consecutive patients with 28 keloids with promising results (World
Brachytherapy Congress 2012).
At the present time with a longer follow up and higher number of patients we
would like to assess the results in terms of recurrence and toxicity of our
cohort.
Study objective
4.OBJECTIVE
To analyse the outcomes, results and complications, of the keloid treatment
with excision followed by immediate adjuvant HDR brachytherapy at the AMC
between July 2007 and October 2014.
Study design
5.STUDY DESIGN
Retrospective observational cohort study with prospective collection of updated
data.
Study burden and risks
nvt
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Inability or unwillingness of the patient to provide informed consent or legally incompetent/incapacitated to do so
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55213.018.15 |