Hypertrophic Scars Clinical Trial
Official title:
Topical Treatment With Glucocorticoids to Prevent Hypertrophic Scars and Keloid Due to Central Venous Access in Children
Most children with cancer need a central venous catheter. These catheters are typically
placed on the anterior thorax, where the risk of hypertrophic scarring and keloid
development is greatly enhanced. A significant part of the children who have survived
childhood cancer are troubled by their scars.
Topical glucocorticoid treatment is known to induce a reduction of the collagen in the
connective tissue.
The investigators hypothesize that treatment with topical glucocorticoids for one week
before and three weeks after removal of a central venous catheter, will reduce the formation
of hypertrophic scarring and keloid development in children.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | July 2016 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 21 Years |
Eligibility |
Inclusion Criteria: - All children and adolescents who have a central venous catheter removed at the Childrens Department of Oncology at Aarhus University Hospital Skejby in the period from March 2010 to July 2011 Exclusion Criteria: - Known allergy towards plaster or fusidic acid |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Arhus University Hospital Skejby | Aarhus | Aarhus N |
Lead Sponsor | Collaborator |
---|---|
Mette Møller Handrup |
Denmark,
Calaminus G, Weinspach S, Teske C, Göbel U. Quality of survival in children and adolescents after treatment for childhood cancer: the influence of reported late effects on health related quality of life. Klin Padiatr. 2007 May-Jun;219(3):152-7. — 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
Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. Eur J Cancer. 2001 Jan;37(2):189-97. — View Citation
Robles DT, Berg D. Abnormal wound healing: keloids. Clin Dermatol. 2007 Jan-Feb;25(1):26-32. Review. — View Citation
Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. — View Citation
Wolfram D, Tzankov A, Pülzl P, Piza-Katzer H. Hypertrophic scars and keloids--a review of their pathophysiology, risk factors, and therapeutic management. Dermatol Surg. 2009 Feb;35(2):171-81. doi: 10.1111/j.1524-4725.2008.34406.x. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal | Twelve months | No | |
Secondary | Judgement of the scar by Patient and observer scar scale after six months | six months | No | |
Secondary | Judgement of the scar by Patient and observer scar scale after twelve months | twelve months | No | |
Secondary | scars measured by the Vancouver Scar Scale six months after central venous catheter removal | six months | No |
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