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Scars After Central Venous Catheters

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01113125
Enrollment
60
Registered
2010-04-29
Start date
2010-03-31
Completion date
2016-07-31
Last updated
2014-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Scars, Keloids

Keywords

hypertrophic scar, keloid, central venous catheter, children, cancer

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.

Interventions

DRUGBetamethason-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

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

Sponsors

Mette Møller Handrup
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
scars measured by the Vancouver Scar Scale twelve months after central venous catheter removalTwelve months

Secondary

MeasureTime frame
Judgement of the scar by Patient and observer scar scale after six monthssix months
Judgement of the scar by Patient and observer scar scale after twelve monthstwelve months
scars measured by the Vancouver Scar Scale six months after central venous catheter removalsix months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026