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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01113125
Other study ID # 2009-015163-14
Secondary ID 2009-015163-1473
Status Active, not recruiting
Phase Phase 3
First received April 27, 2010
Last updated February 11, 2014
Start date March 2010
Est. completion date July 2016

Study information

Verified date February 2014
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date July 2016
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Drug:
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
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

Locations

Country Name City State
Denmark Arhus University Hospital Skejby Aarhus Aarhus N

Sponsors (1)

Lead Sponsor Collaborator
Mette Møller Handrup

Country where clinical trial is conducted

Denmark, 

References & Publications (6)

Calaminus G, Weinspach S, Teske C, Göbel 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. — View Citation

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. — View Citation

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. — View Citation

Robles DT, Berg D. Abnormal wound healing: keloids. Clin Dermatol. 2007 Jan-Feb;25(1):26-32. Review. — View Citation

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. — View Citation

Wolfram D, Tzankov A, Pülzl 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary scars measured by the Vancouver Scar Scale twelve months after central venous catheter removal Twelve months No
Secondary Judgement of the scar by Patient and observer scar scale after six months six months No
Secondary Judgement of the scar by Patient and observer scar scale after twelve months twelve months No
Secondary scars measured by the Vancouver Scar Scale six months after central venous catheter removal six months No
See also
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Completed NCT00993005 - CICATRIX in the Treatment of Hypertrophic Scars and Keloids Scars Phase 3
Withdrawn NCT02546076 - Comparison of Dual-mode ER:YAG Laser in Patients With Long Keloid/Hypertrophic Scars Phase 2
Withdrawn NCT01858038 - Gene Expression During Surgical Scar Remodeling by Fractional Photothermolysis N/A
Active, not recruiting NCT04389619 - Fractional Microneedling RF vs Intralesional Steroid With & Without Microneedling in Hypertrophic Scars N/A
Active, not recruiting NCT00849004 - Prevention of Hypertrophic Scars or Keloids N/A
Completed NCT00142441 - Effect of Pulse Width on Scar Treatment Using a 595-nm Pulsed Dye Laser N/A
Completed NCT01078428 - Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars Phase 4
Withdrawn NCT02655211 - Laser Induced Bioengineered Remodeling of Thermally Injured Skin Trial N/A
Completed NCT02487212 - Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery Phase 4
Active, not recruiting NCT04532840 - Effect of Cryotherpy on Hypertrophic Scar Phase 2/Phase 3
Recruiting NCT00548210 - Effectivity of Dermatix in Promoting Scar Maturation Phase 3