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
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