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Scars After Central Venous Catheters

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mette Møller Handrup, Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT01113125
First received: April 27, 2010
Last updated: February 11, 2014
Last verified: February 2014
  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-valerate 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:


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 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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, 73191198, 20090206
Study First Received: April 27, 2010
Last Updated: February 11, 2014
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:
Cicatrix, Hypertrophic
Hypertrophy
Keloid
Cicatrix
Collagen Diseases
Connective Tissue Diseases
Fibrosis
Pathologic Processes
Pathological Conditions, Anatomical
Fusidic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014