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High Dose Rate Brachytherapy for Treatment of Keloids

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ClinicalTrials.gov Identifier: NCT02005055
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : December 9, 2013
Sponsor:
Information provided by (Responsible Party):
Michiel van Leeuwen, VU University Medical Center

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.

Condition or disease Intervention/treatment
Keloid Procedure: Surgical excision with adjuvant high-dose-rate brachytherapy

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)

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Study Type : Observational
Actual Enrollment : 43 participants
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Use of High-dose-rate Brachytherapy for the Treatment of Recalcitrant Keloids
Study Start Date : January 2003
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Group/Cohort Intervention/treatment
Patients with recalcitrant keloid scars
All patients with keloids insensitive to other treatments
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.
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 Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with recalcitrant keloids meeting inclusion criteria
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005055


Locations
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Netherlands
VUmc
Amsterdam, Noord-Holland, Netherlands, 1081HV
Sponsors and Collaborators
VU University Medical Center
Investigators
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Principal Investigator: Michiel CE Leeuwen van, MD VUmc

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michiel van Leeuwen, MD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02005055     History of Changes
Other Study ID Numbers: PlastChirVUmc 01
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: December 2013

Keywords provided by Michiel van Leeuwen, VU University Medical Center:
Brachytherapy
Radiotherapy
Scar treatment

Additional relevant MeSH terms:
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Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes