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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.

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20907
Enrollment
36
Registered
2006-10-24
Start date
2007-04-10
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

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

Interventions

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

Sponsors

-
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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).

Contacts

Public ContactH.A. Heij

Academic Medical Center (AMC), Emma Children's Hospital and VU University Medical Center, Department of Pediatric Surgery (9d32), P.O. Box 22660

h.a.heij@amc.uva.nl or ha.heij@vumc.nl+31 (0)20 5665693

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)