Scars After Central Venous Catheters

Phase 3

• Conditions: Hypertrophic Scars; Keloids
• Interventions: Drug: Betamethason-17-valerate and fusidic acid; Drug: Fusidic Acid

• Registration Number: NCT01113125
• Lead Sponsor: Mette Møller Handrup

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-04-28
• Study First Posted: 2010-04-29
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-11
• Last Update Posted: 2014-02-12
• Primary Completion: 2014-08
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fucicort	Betamethason-17-valerate and fusidic acid	-
Fucidin	Fusidic Acid	-

Primary Outcome Measures

Name	Time	Method
scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal	Twelve months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Arhus University Hospital Skejby; 🇩🇰 Aarhus, Aarhus N, Denmark