Scars After Central Venous Catheters - Full Text View

Purpose

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.

Condition	Intervention	Phase
Hypertrophic Scars Keloids	Drug: Betamethason-17-valerat and fusidic acid Drug: Fusidic Acid	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Topical Treatment With Glucocorticoids to Prevent Hypertrophic Scars and Keloid Due to Central Venous Access in Children

Resource links provided by NLM:

MedlinePlus related topics: Cancer Scars Steroids

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:

scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal [ Time Frame: Twelve months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Judgement of the scar by Patient and observer scar scale after six months [ Time Frame: six months ] [ Designated as safety issue: No ]
Judgement of the scar by Patient and observer scar scale after twelve months [ Time Frame: twelve months ] [ Designated as safety issue: No ]
scars measured by the Vancouver Scar Scale six months after central venous catheter removal [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	March 2010
Estimated Study Completion Date:	July 2016
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fucicort	Drug: Betamethason-17-valerat and fusidic acid 0.4 cm creme is applied and covered with a plaster (treatment under occlusion). Dosage every second or third day Treatment is started one week before removal of the central venous catheter and continued for four weeks
Placebo Comparator: Fucidin	Drug: Fusidic Acid 0.4 cm creme is applied and covered with a plaster (treatment under occlusion). Dosage every second or third day Treatment is started one week before removal of the central venous catheter and continued for four weeks

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113125

Contacts

Contact: Henrik Hasle, Professor	0045 8949 6841	hasle@dadlnet.dk
Contact: Mette M Handrup, MD	0045 8949 6749	handrup@ki.au.dk

Locations

Denmark
Arhus University Hospital Skejby	Recruiting
Aarhus, Aarhus N, Denmark, 8200
Contact: Henrik Hasle, Professor 0045 8949 6841 hasle@dadlnet.dk
Contact: Mette M Handrup, MD 0045 8949 6749 handrup@ki.au.dk

Sponsors and Collaborators

Aarhus University Hospital

Investigators

Principal Investigator:

Henrik Hasle, Professor

Aarhus University Hospital

More Information

Publications:

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. Review.

Robles DT, Berg D. Abnormal wound healing: keloids. Clin Dermatol. 2007 Jan-Feb;25(1):26-32. Review.

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.

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.

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.

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.

Responsible Party:	Henrik Hasle, Department of Pediatrics, Aarhus University Hospital, Skejby
ClinicalTrials.gov Identifier:	NCT01113125 History of Changes
Other Study ID Numbers:	2009-015163-14, 2009-015163-14, 73191198, 20090206
Study First Received:	April 27, 2010
Last Updated:	August 12, 2011
Health Authority:	Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Aarhus University Hospital:

hypertrophic scar
keloid
central venous catheter
children
cancer

Additional relevant MeSH terms:

Hypertrophy
Keloid
Cicatrix, Hypertrophic
Cicatrix
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases
Fibrosis
Pathologic Processes

Fusidic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013