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
Secondary identifying numbers 06/146; NTR815
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

Study designRandomised, controlled, parallel group, multicentre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymLiLa
Study objectives1. 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) studiedHypertrophic scarring
InterventionThe application of a silicone gel sheet to optimise wound healing after removal of the ICVAD, and to reduce the size of the scar.
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)
Primary outcome measureOutcome 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 measuresNo secondary outcome measures
Overall study start date01/10/2006
Completion date01/10/2008

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Year
Upper age limit18 Years
SexBoth
Target number of participants36
Key inclusion criteria1. 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 criteriaChildren 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 enrolment01/10/2006
Date of final enrolment01/10/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre

Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Website http://www.vumc.nl/
ROR logo "ROR" https://ror.org/00q6h8f30

Funders

Funder type

Hospital/treatment centre

Vrije University Medical Centre (VUMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan