Scars After Central Venous Catheters

Mette Møller Handrup

Status and phase: Unknown; Phase 3

Conditions: Keloids; Hypertrophic Scars

Treatments: Drug: Fusidic Acid; Drug: Betamethason-17-valerate and fusidic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01113125

73191198 (Other Identifier)

20090206 (Other Identifier)

2009-015163-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

Fucicort

Experimental group

Treatment:

Drug: Betamethason-17-valerate and fusidic acid

Fucidin

Placebo Comparator group

Treatment:

Drug: Fusidic Acid