Scars After Central Venous Catheters

NCT01113125 | Unknown Phase 3 DMC

• 3 other identifiers: 2009-015163-147319119820090206
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Scars; Keloids

Keywords

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

Outcome Measures

Primary Outcomes (1)

• scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal

  Twelve months

Secondary Outcomes (3)

• 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

Study Arms (2)

Fucicort

EXPERIMENTAL

Drug: Betamethason-17-valerate and fusidic acid

Fucidin

PLACEBO COMPARATOR

Drug: Fusidic Acid

Interventions

Betamethason-17-valerate and fusidic acid DRUG

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

Fucicort

Fusidic Acid DRUG

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

Fucidin

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Known allergy towards plaster or fusidic acid

Sponsors & Collaborators

• Mette Møller Handrup: lead

Study Sites (1)

Arhus University Hospital Skejby

Aarhus, Aarhus N, 8200, Denmark

Location

Related Publications (6)

• Wolfram D, Tzankov A, Pulzl P, Piza-Katzer H. Hypertrophic scars and keloids--a review of their pathophysiology, risk factors, and therapeutic management. Dermatol Surg. 2009 Feb;35(2):171-81. doi: 10.1111/j.1524-4725.2008.34406.x.

  PMID: 19215252 BACKGROUND

• Robles DT, Berg D. Abnormal wound healing: keloids. Clin Dermatol. 2007 Jan-Feb;25(1):26-32. doi: 10.1016/j.clindermatol.2006.09.009.

  PMID: 17276198 BACKGROUND

• Calaminus G, Weinspach S, Teske C, Gobel U. Quality of survival in children and adolescents after treatment for childhood cancer: the influence of reported late effects on health related quality of life. Klin Padiatr. 2007 May-Jun;219(3):152-7. doi: 10.1055/s-2007-973846.

  PMID: 17525909 BACKGROUND

• Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. doi: 10.1097/00004630-199005000-00014.

  PMID: 2373734 BACKGROUND

• Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.

  PMID: 15253184 BACKGROUND

• Hopwood P, Fletcher I, Lee A, Al Ghazal S. A body image scale for use with cancer patients. Eur J Cancer. 2001 Jan;37(2):189-97. doi: 10.1016/s0959-8049(00)00353-1.

  PMID: 11166145 BACKGROUND

MeSH Terms

Conditions

Cicatrix, Hypertrophic; Keloid; Neoplasms

Interventions

Fusidic Acid

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cholestadienols; Cholestadienes; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Membrane Lipids; Lipids

Study Officials

• Henrik Hasle, Professor

  Aarhus University Hospital Skejby

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: April 29, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: July 1, 2016
• Last Updated: February 12, 2014

Record last verified: 2014-02

Locations

DK (1)