Condition category
Signs and Symptoms
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
05/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H A Heij

ORCID ID

Contact details

Academic Medical Centre (AMC)
Emma Children's Hospital and Vrije University Medical Centre
Department of Pediatric Surgery (9d32)
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 5693
h.a.heij@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

06/146; NTR815

Study information

Scientific title

Acronym

LiLa

Study hypothesis

1. Implantable central venous access device (ICVAD) removal, followed by six months of silicone gel sheet use, will result in a scar width within the normal range, and normal scar structure, and thus will be superior to two months of silicone gel sheets and no gel sheets.
2. A smaller and/or less hypertrophic scar will reduce the chance of being reminded to the stressful period during cancer treatment, resulting in a better body image and quality of life scores.

Ethics approval

Received from the local medical ethics committee

Study design

Randomised, controlled, parallel group, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hypertrophic scarring

Intervention

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

Intervention type

Device

Phase

Not Specified

Drug names

Primary outcome measures

Outcome variables regarding scar aspect:
1. Width in millimetres
2. Length in millimetres
3. Height (normal, 1 - 2 mm, 3 - 4 mm, 5 - 6 mm, more than 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 standardised questionnaires on body image (minimum score eight, maximum score 40), and quality of life (functional and symptom status: 11 items with a range from one to four, global health status: two items with a range from one to seven).

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/10/2006

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

36

Participant 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.

Recruitment start date

01/10/2006

Recruitment end date

01/10/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.vumc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Vrije University Medical Centre (VUMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes