Silicone gel sheet to improve cosmetic outcome of the scar after removal of an implantable central venous access device (ICVAD) in childhood cancer survivors.

Recruiting

Conditions: In childhood cancer survivors, for unknown reasons, disfiguring and extremely wide scars are observed after Implantable central venous access device (ICVAD) removal.

Registration Number: NL-OMON20907

Lead Sponsor: -

Brief Summary: A manuscript titled Hypertrophic scars due to implantable central venous access device in childhood cancer survivors (ASO-2006-08-0435) has been submitted by Dr. Antoinette Schouten-van Meeteren to the Annals of Surgical Oncology.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 36

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome variables regarding scar aspect: <br>1. Width in millimeters;<br>2. Length in millimeters;<br>3. Height (normal, 1-2 mm, 3-4 mm, 5-6 mm, >6 mm);<br>4. Vascularisaty (normal, pink, red, purple);<br>5. Pigmentation (normal, hypopigmentation, mixed pigmentation, hyperpigmentation);<br>6. Pliability (normal, supple, yielding, firm, adherent);<br>7. Pain (nine point scale);<br>8. Itching (nine point scale).<br><br>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).

Secondary Outcome Measures