High Dose Rate Brachytherapy for Treatment of Keloids

Keloid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005055
• Other study ID #: PlastChirVUmc 01
• Status: Completed
• Phase: N/A
• First received: November 26, 2013
• Last updated: December 3, 2013
• Start date: January 2003
• Est. completion date: December 2010

Study information

• Verified date: December 2013
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Keloid

Intervention

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.

Locations

Country	Name	City	State
Netherlands	VUmc	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Cosman B, Wolff M. Bilateral earlobe keloids. Plast Reconstr Surg. 1974 May;53(5):540-3. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Scar Quality	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)	Pre- and postoperative	No

External Links

•   VU University medical center