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Scars After Central Venous Catheters

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ClinicalTrials.gov Identifier: NCT01113125
Recruitment Status : Unknown
Verified February 2014 by Mette Møller Handrup, Aarhus University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 29, 2010
Last Update Posted : February 12, 2014
Sponsor:
Information provided by (Responsible Party):
Mette Møller Handrup, Aarhus University Hospital

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.


Condition or disease Intervention/treatment Phase
Hypertrophic Scars Keloids Drug: Betamethason-17-valerate and fusidic acid Drug: Fusidic Acid Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2010
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars Steroids
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fucicort Drug: Betamethason-17-valerate 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



Primary Outcome Measures :
  1. scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal [ Time Frame: Twelve months ]

Secondary Outcome Measures :
  1. Judgement of the scar by Patient and observer scar scale after six months [ Time Frame: six months ]
  2. Judgement of the scar by Patient and observer scar scale after twelve months [ Time Frame: twelve months ]
  3. scars measured by the Vancouver Scar Scale six months after central venous catheter removal [ Time Frame: six months ]


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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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): NCT01113125


Locations
Denmark
Arhus University Hospital Skejby
Aarhus, Aarhus N, Denmark, 8200
Sponsors and Collaborators
Mette Møller Handrup
Investigators
Principal Investigator: Henrik Hasle, Professor Aarhus University Hospital Skejby

Publications:
Responsible Party: Mette Møller Handrup, MD, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01113125     History of Changes
Other Study ID Numbers: 2009-015163-14
2009-015163-14 ( EudraCT Number )
73191198 ( Other Identifier: Danish Medicines Agency )
20090206 ( Other Identifier: The Danish National Committee on Biomedical Research Ethics )
First Posted: April 29, 2010    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014

Keywords provided by Mette Møller Handrup, Aarhus University Hospital:
hypertrophic scar
keloid
central venous catheter
children
cancer

Additional relevant MeSH terms:
Hypertrophy
Keloid
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes
Fusidic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action