High Dose Rate Brachytherapy for Treatment of Keloids

CompletedOBSERVATIONAL
Enrollment

43

Participants

Timeline

Start Date

January 31, 2003

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2010

Conditions
Keloid
Interventions
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.

Trial Locations (1)

1081HV

VUmc, Amsterdam

All Listed Sponsors
lead

Amsterdam UMC, location VUmc

OTHER

NCT02005055 - High Dose Rate Brachytherapy for Treatment of Keloids | Biotech Hunter | Biotech Hunter