High Dose Rate Brachytherapy for Treatment of Keloids

N/ACompletedNCT02005055

Amsterdam UMC, location VUmc43 enrolled

Overview

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.

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)

Study Type

OBSERVATIONAL

Enrollment

Conditions

Keloid

Interventions

Surgical excision with adjuvant high-dose-rate brachytherapyPROCEDURE

The keloid was excised extralesionally and subsequently a metal tipped Varisource catheter was positioned between the dermal edges of the wound, 5 mm below the surface of the skin and extending out of the skin beyond the wound. Primary wound closure was performed and patients were transferred to the radiation department, where the catheter was connected to the Iridium-192 remote control afterloader. The planning target volume was defined as a cylinder along the axis of the scar, with a central diameter of 5mm. Patients received 2 fractions of HighDoseRate brachytherapy. Within 4 hours after the resection, the first brachytherapy fraction of 6 Gy at 5mm of the source axis was given. Within 24 hours after the first fraction a second fraction of 6Gy was administered to a total dose of 12Gy in 2 days. After the second fraction the catheter was gently removed.

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

VUmc

Amsterdam, North Holland, Netherlands

Outcomes

Primary Outcomes

Recurrence

Recurrence was defined as a growing, pruritic, nodular scar as described by Cosman and Wolff(1)

Time frame: At a minimum of one year post surgery

Secondary Outcomes

Scar Quality

The scar (pre-operative) and the residual scar (post-operative at 1 week, 3,6,12 months and 5 year) was examined, photographs were taken, surface area was measured and the 'Patient and Observer Scar Assessment Scale' was obtained (2)

Time frame: Pre- and postoperative

Data from ClinicalTrials.gov

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