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 |
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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
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 |
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h.a.heij@amc.uva.nl |
Study information
Study design | Randomised, controlled, parallel group, multicentre trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | |
Primary outcome measure | 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 study start date | 01/10/2006 |
Completion date | 01/10/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Lower age limit | 1 Year |
Upper age limit | 18 Years |
Sex | Both |
Target number of participants | 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
1100 DD
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Website | http://www.vumc.nl/ |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |