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

ISRCTN	ISRCTN77132184
DOI	https://doi.org/10.1186/ISRCTN77132184
Protocol serial number	06/146; NTR815
Sponsor	Vrije University Medical Centre (VUMC) (The Netherlands)
Funder	Vrije University Medical Centre (VUMC) (The Netherlands)

Submission date: 28/12/2006
Registration date: 28/12/2006
Last edited: 05/11/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr H A Heij
Scientific

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

Phone	+31 (0)20 566 5693
Email	h.a.heij@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Randomised, controlled, parallel group, multicentre trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	LiLa
Study objectives	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(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/10/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	18 Years
Sex	All
Target sample size at registration	36
Key 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
Key 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.
Date of first enrolment	01/10/2006
Date of final enrolment	01/10/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre (AMC)

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan