NCT02005055

High Dose Rate Brachytherapy for Treatment of Keloids

Prospective Evaluation of the Use of High-dose-rate Brachytherapy for the Treatment of Recalcitrant Keloids

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Keloid

Interventions

Type	Name	Description
PROCEDURE	Surgical excision with adjuvant high-dose-rate brachytherapy	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.

Timeline

• Start date: 2003-01-01
• Primary completion: 2009-12-01
• Completion: 2010-12-01
• First posted: 2013-12-09
• Last updated: 2013-12-09

Locations

1 site across 1 country: Netherlands