Scars After Central Venous Catheters

Study Overview
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Brief Summary
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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.

Official Title
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Topical Treatment With Glucocorticoids to Prevent Hypertrophic Scars and Keloid Due to Central Venous Access in Children

Conditions
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Hypertrophic Scars, Keloids

Intervention / Treatment
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* Drug: Betamethason-17-valerate and fusidic acid
* Drug: Fusidic Acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fucicort<br> | Drug: Betamethason-17-valerate and fusidic acid<br>* 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<br>|
| Placebo Comparator: Fucidin<br> | Drug: Fusidic Acid<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal |  | Twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Judgement of the scar by Patient and observer scar scale after six months |  | six months | 
| Judgement of the scar by Patient and observer scar scale after twelve months |  | twelve months | 
| scars measured by the Vancouver Scar Scale six months after central venous catheter removal |  | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertrophic scar, keloid, central venous catheter, children, cancer