Clinical trial NCT01113125: Scars After Central Venous Catheters
Official title: Topical Treatment With Glucocorticoids to Prevent Hypertrophic Scars and Keloid Due to Central Venous Access in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertrophic Scars
Keloids
Keywords: hypertrophic scar
keloid
central venous catheter
children
cancer
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2010-04-29
Enrollment: 60
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal
timeFrame: Twelve months
Secondary outcomes:
measure: Judgement of the scar by Patient and observer scar scale after six months
timeFrame: six months
measure: Judgement of the scar by Patient and observer scar scale after twelve months
timeFrame: twelve months
measure: scars measured by the Vancouver Scar Scale six months after central venous catheter removal
timeFrame: six months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Arhus University Hospital Skejby
state: Aarhus N
Study officials:
affiliation: Aarhus University Hospital Skejby
name: Henrik Hasle, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolfram D, Tzankov A, Pulzl 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.
citation: Robles DT, Berg D. Abnormal wound healing: keloids. Clin Dermatol. 2007 Jan-Feb;25(1):26-32. doi: 10.1016/j.clindermatol.2006.09.009.
citation: Calaminus G, Weinspach S, Teske C, Gobel 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. doi: 10.1055/s-2007-973846.
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. doi: 10.1097/00004630-199005000-00014.
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. doi: 10.1097/01.prs.0000122207.28773.56.
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. doi: 10.1016/s0959-8049(00)00353-1.