Skip to main content
OpenTrials
Completed

NCT Number: NCT02005055

High Dose Rate Brachytherapy for Treatment of Keloids

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Keloid Cicatrix Collagen Diseases Connective Tissue Diseases Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

VUmc

Amsterdam, North Holland, 1081HV, Netherlands

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical excision with adjuvant high-dose-rate brachytherapy

Procedure

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.

Other names: Metal tipped Varisource catheter (external diameter: 1.6mm, length: 150cm, Varian medical systems, Palo Alto, USA), Monocryl 4-0 or 5-0, Iridium-192 remote control afterloader (Varisource, Varian medical systems, Palo Alto, USA)

Primary outcomes

  1. Recurrence

    Time frame: 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 outcomes

  1. Scar Quality

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2009
Study completion
2010
First posted
Dec 9, 2013
Registry last updated
Dec 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.