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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR815 |
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Date of registration:
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24/10/2006 |
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Primary sponsor: |
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Public title:
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Silicone gel sheet to improve cosmetic outcome of the scar after removal of an implantable central venous access device (ICVAD) in childhood cancer survivors.
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Scientific title:
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Silicone gel sheet to improve structure and cosmetic outcome of the scar after removal of an implantable central venous access device (ICVAD) in childhood cancer survivors. - LiLa |
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Date of first enrolment:
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10/4/2007 |
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Target sample size:
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36 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=815 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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H.A.
Heij |
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Address:
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Academic Medical Center (AMC), Emma Children's Hospital and VU University Medical Center, Department of Pediatric Surgery (9d32),
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5665693 |
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Email:
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h.a.heij@amc.uva.nl or ha.heij@vumc.nl |
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Affiliation:
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Name:
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K.I.
Braam |
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Address:
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VU University Medical Center, Department of Pediatrics,
P.O. Box 7075
1007 MB
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 4449110 / +31 (2)20 4442420 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Children who are in follow-up for cancer treatment, and have an ICVAD, which is planned to be removed, are eligible for the study;
2. The children should be between one and eighteen years old.
Exclusion criteria: Children are excluded for the study when they had an ICVAD on an other location than the chest wall, when the ICVAD was removed because of an infection, or when the child received radiotherapy on the chest. This latter criterion is because of the damage to the skin during radiotherapy.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Hypertrophic scars
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Intervention(s)
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The application of a silicone gel sheet to optimize wound healing after removal of the ICVAD, and to reduce the size of the scar.
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Primary Outcome(s)
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Outcome variables regarding scar aspect:
1. Width in millimeters;
2. Length in millimeters;
3. Height (normal, 1-2 mm, 3-4 mm, 5-6 mm, >6 mm);
4. Vascularisaty (normal, pink, red, purple);
5. Pigmentation (normal, hypopigmentation, mixed pigmentation, hyperpigmentation);
6. Pliability (normal, supple, yielding, firm, adherent);
7. Pain (nine point scale);
8. Itching (nine point scale).
Children whose age is of twelve to eighteen years get standardized questionnaires on body image (minimum score 8, maximum score 40), and quality of life (functional and symptom status: 11 items with a range from 1-4, global health status: 2 items with a range from 1-7).
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Secondary ID(s)
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06/146
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ISRCTN77132184
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Source(s) of Monetary Support
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VU University Medical Center
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