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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30005

Enrollment

Registered

2006-11-10

Start date

2006-10-01

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

abnormal scarring Hypertrophic scarring

Interventions

Intervention. The application of a silicone gel sheet to optimize wound healing after removal of the ICVAD, and to reduce the size of the scar.

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Outcome variables regarding scar aspect: - Width in millimetres - Length in millimetres - Height (normal, 1-2 mm, 3-4 mm, 5-6 mm, >6 mm) - Vascularity (normal, pink, red, purple) - Pigmentation (normal, hypopigmentation, mixed pigmentation, hyperpigmentation) - Pliability (normal, supple, yielding, firm, adherent) - Pain (nine point scale) - 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).	—

Measure

Time frame

Outcome variables regarding scar aspect: - Width in millimetres - Length in millimetres - Height (normal, 1-2 mm, 3-4 mm, 5-6 mm, >6 mm) - Vascularity (normal, pink, red, purple) - Pigmentation (normal, hypopigmentation, mixed pigmentation, hyperpigmentation) - Pliability (normal, supple, yielding, firm, adherent) - Pain (nine point scale) - 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).

—

Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)