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Scars After Central Venous Catheters

Primary Purpose

Hypertrophic Scars, Keloids

Status
Unknown status
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Betamethason-17-valerate and fusidic acid
Fusidic Acid
Sponsored by
Mette Møller Handrup
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertrophic Scars focused on measuring hypertrophic scar, keloid, central venous catheter, children, cancer

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arhus University Hospital Skejby

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fucicort

Fucidin

Arm Description

Outcomes

Primary Outcome Measures

scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal

Secondary Outcome Measures

Judgement of the scar by Patient and observer scar scale after six months
Judgement of the scar by Patient and observer scar scale after twelve months
scars measured by the Vancouver Scar Scale six months after central venous catheter removal

Full Information

First Posted
April 27, 2010
Last Updated
February 11, 2014
Sponsor
Mette Møller Handrup
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1. Study Identification

Unique Protocol Identification Number
NCT01113125
Brief Title
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mette Møller Handrup

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scars, Keloids
Keywords
hypertrophic scar, keloid, central venous catheter, children, cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fucicort
Arm Type
Experimental
Arm Title
Fucidin
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Betamethason-17-valerate and fusidic acid
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Fusidic Acid
Intervention Description
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 Measure Information:
Title
scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal
Time Frame
Twelve months
Secondary Outcome Measure Information:
Title
Judgement of the scar by Patient and observer scar scale after six months
Time Frame
six months
Title
Judgement of the scar by Patient and observer scar scale after twelve months
Time Frame
twelve months
Title
scars measured by the Vancouver Scar Scale six months after central venous catheter removal
Time Frame
six months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Hasle, Professor
Organizational Affiliation
Aarhus University Hospital Skejby
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arhus University Hospital Skejby
City
Aarhus
State/Province
Aarhus N
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
19215252
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.
Results Reference
background
PubMed Identifier
17276198
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.
Results Reference
background
PubMed Identifier
17525909
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.
Results Reference
background
PubMed Identifier
2373734
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.
Results Reference
background
PubMed Identifier
15253184
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.
Results Reference
background
PubMed Identifier
11166145
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.
Results Reference
background

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Scars After Central Venous Catheters

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