High Dose Rate Brachytherapy for Treatment of Keloids

NCT02005055 | Completed

• 1 other identifier: PlastChirVUmc 01
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Keloid

Keywords

Brachytherapy; Radiotherapy; Scar treatment

Outcome Measures

Primary Outcomes (1)

• Recurrence

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

  At a minimum of one year post surgery

Secondary Outcomes (1)

• Scar Quality

  Pre- and postoperative

Study Arms (1)

Patients with recalcitrant keloid scars

All patients with keloids insensitive to other treatments

Procedure: Surgical excision with adjuvant high-dose-rate brachytherapy

Interventions

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.

Also known as: 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)

Patients with recalcitrant keloid scars

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with recalcitrant keloids meeting inclusion criteria

You may qualify if:

• 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.

You may not qualify if:

• keloids not suitable for excision with primary closure due to its size or anatomical location
• pregnancy or diabetes

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VUmc

Amsterdam, North Holland, 1081HV, Netherlands

Location

Related Publications (3)

• Cosman B, Wolff M. Bilateral earlobe keloids. Plast Reconstr Surg. 1974 May;53(5):540-3. doi: 10.1097/00006534-197405000-00008. No abstract available.

  PMID: 4821203 BACKGROUND

• Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.

  PMID: 15253184 BACKGROUND

• van Leeuwen MCE, Stokmans SC, Bulstra AJ, Meijer OWM, van Leeuwen PAM, Niessen FB. High-dose-rate brachytherapy for the treatment of recalcitrant keloids: a unique, effective treatment protocol. Plast Reconstr Surg. 2014 Sep;134(3):527-534. doi: 10.1097/PRS.0000000000000415.

  PMID: 25158710 DERIVED

Related Links

• VU University medical center

MeSH Terms

Conditions

Keloid

Interventions

Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Michiel CE Leeuwen van, MD

  VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 9, 2013
• Study Start: January 1, 2003
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

NL (1)