Overview

This trial is active, not recruiting.

Conditions hypertrophic scars, keloids
Treatments betamethason-17-valerate and fusidic acid, fusidic acid
Phase phase 3
Sponsor Mette Møller Handrup
Start date March 2010
End date August 2014
Trial size 60 participants
Trial identifier NCT01113125, 2009-015163-14, 20090206, 73191198

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
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)
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 Outcomes

Measure
scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal
time frame: Twelve months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants up to 21 years old.

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

Additional Information

Official title Topical Treatment With Glucocorticoids to Prevent Hypertrophic Scars and Keloid Due to Central Venous Access in Children
Principal investigator Henrik Hasle, Professor
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Aarhus University Hospital.