Clinical trial NCT02005055: High Dose Rate Brachytherapy for Treatment of Keloids
Official title: Prospective Evaluation of the Use of High-dose-rate Brachytherapy for the Treatment of Recalcitrant Keloids
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keloid
Keywords: Brachytherapy
Radiotherapy
Scar treatment
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 43
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with recalcitrant keloids meeting inclusion criteria

Brief summary: This prospective study evaluates the outcome of surgical excision with adjuvant high-dose-rate brachytherapy for the treatment of recalcitrant keloids. Main outcomes are recurrence rate, scar quality and physical complaints.

Detailed description: This prospective evaluation describes the outcome of surgical excision with adjuvant high-dose-rate brachytherapy for the treatment of recalcitrant keloids in a large mixed Fitzpatrick skin type patient population. After intralesional excision, a unique low dose radiation scheme of 2x6Gray (Gy) was administered in 2 fractions: the first within 4 hours, the second within 24 hours. Keloids were evaluated pre- and postoperative (1 week, 3, 6, 12 months, 5years). Scars were measured and recurrence was judged. An evaluation of the outcome of the scars was obtained using the Patient and Observer Scar Assessment Scale. Statistical analyses were conducted using SPSS version 20.0 (SPSS, Inc, Chicago, III)

Eligibility criteria: Inclusion Criteria:

* Keloid defined as excessive scar tissue raised above skin level and proliferating beyond the confines of the original lesion. Keloids were distinguished from hypertrophic scars based on the clinical judgment of experienced plastic surgeons and on the age of the scar (\>1yr)
* the keloid had been proven insensitive to at least one other treatment
* patients had to be older than 10 years of age.

Exclusion Criteria:

* keloids not suitable for excision with primary closure due to its size or anatomical location
* pregnancy or diabetes

Primary outcomes:
measure: Recurrence
timeFrame: At a minimum of one year post surgery
Secondary outcomes:
measure: Scar Quality
timeFrame: Pre- and postoperative
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VUmc
state: Noord-Holland
Study officials:
affiliation: VUmc
name: Michiel CE Leeuwen van, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cosman B, Wolff M. Bilateral earlobe keloids. Plast Reconstr Surg. 1974 May;53(5):540-3. doi: 10.1097/00006534-197405000-00008. No abstract available.
citation: Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
citation: van Leeuwen MCE, Stokmans SC, Bulstra AJ, Meijer OWM, van Leeuwen PAM, Niessen FB. High-dose-rate brachytherapy for the treatment of recalcitrant keloids: a unique, effective treatment protocol. Plast Reconstr Surg. 2014 Sep;134(3):527-534. doi: 10.1097/PRS.0000000000000415.