High Dose Rate Brachytherapy for Treatment of Keloids

Completed

• Conditions: Keloid
• Interventions: Procedure: Surgical excision with adjuvant high-dose-rate brachytherapy

• Registration Number: NCT02005055
• Lead Sponsor: Amsterdam UMC, location VUmc

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)

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Study First Submitted: 2013-11-26
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-03
• Last Update Submitted: 2013-12-03
• Study First Posted: 2013-12-09
• Last Update Posted: 2013-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with recalcitrant keloid scars	Surgical excision with adjuvant high-dose-rate brachytherapy	All patients with keloids insensitive to other treatments

Primary Outcome Measures

Name	Time	Method
Recurrence	At a minimum of one year post surgery	Recurrence was defined as a growing, pruritic, nodular scar as described by Cosman and Wolff(1)

Secondary Outcome Measures

Name	Time	Method
Scar Quality	Pre- and postoperative	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)

Trial Locations

Locations (1)

VUmc; 🇳🇱 Amsterdam, Noord-Holland, Netherlands