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

• Conditions: abnormal scarring; Hypertrophic scarring; 10014982

• Registration Number: NL-OMON30005
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

Children between one and 18 years old, who are in follow-up for cancer treatment, and have an implanted central venous access device (ICVAD), which is planned to be removed.

Exclusion Criteria

1. The implanted central venous access device (ICVAD) is located on an other location than the chest wall.
2. The ICVAD will be removed because of an infection.
3. The child received radiotherapy on the chest.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Outcome variables regarding scar aspect:<br /><br>- Width in millimetres<br /><br>- Length in millimetres<br /><br>- Height (normal, 1-2 mm, 3-4 mm, 5-6 mm, >6 mm)<br /><br>- Vascularity (normal, pink, red, purple)<br /><br>- Pigmentation (normal, hypopigmentation, mixed pigmentation,<br /><br>hyperpigmentation)<br /><br>- Pliability (normal, supple, yielding, firm, adherent)<br /><br>- Pain (nine point scale)<br /><br>- Itching (nine point scale).<br /><br><br /><br>Children whose age is of twelve to eighteen years get standardized<br /><br>questionnaires on body image (minimum score 8, maximum score 40) and quality of<br /><br>life (functional and symptom status: 11 items with a range from 1-4, global<br /><br>health status: 2 items with a range from 1-7). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-</p><br>