Aim. The general aim of the study is to determine if cosmetic outcome will improve by applying silicone bandages to the wound. Cosmetic outcome is analyzed by size, colour, and surface of the scar. In addition it will be evaluated whether the…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome variables regarding scar aspect:
- Width in millimetres
- Length in millimetres
- Height (normal, 1-2 mm, 3-4 mm, 5-6 mm, >6 mm)
- Vascularity (normal, pink, red, purple)
- Pigmentation (normal, hypopigmentation, mixed pigmentation,
hyperpigmentation)
- Pliability (normal, supple, yielding, firm, adherent)
- Pain (nine point scale)
- Itching (nine point scale).
Children whose age is of twelve to eighteen years get standardized
questionnaires on body image (minimum score 8, maximum score 40) and quality of
life (functional and symptom status: 11 items with a range from 1-4, global
health status: 2 items with a range from 1-7).
Secondary outcome
-
Background summary
Background.
Childhood cancer survivors often have physical scars with emotional
consequences. Disfiguring scars can induce lower self-esteem or self-image.
Therefore it is important for the child to improve the appearance of a scar.
Causes of scars due to cancer, or its treatment can be diverse. Surgery on
solid tumors, and bone marrow or lumbar punctures, catheters or central venous
access devices can cause scars.
An implantable central venous access device (ICVAD) is located subcutaneously,
preferable on the chest wall, and sometimes at the lower ribcage or in the
antecubital area. Its application is common practice in children treated with
chemotherapy. For unknown reasons disfiguring and extremely wide scars are
observed after ICVAD removal. To determine the extent of abnormal scarring we
studied the ICVAD scars of 50 childhood cancer survivors, treated at the VU
university medical center. Both physical and psychosocial impact of the scar
was evaluated. Abnormal scarring was evident. Both parents and children
reported emotional distress by this scar. Based on these findings this
intervention study is initiated.
Study objective
Aim.
The general aim of the study is to determine if cosmetic outcome will improve
by applying silicone bandages to the wound. Cosmetic outcome is analyzed by
size, colour, and surface of the scar. In addition it will be evaluated whether
the therapeutic effect is influenced by the duration of silicone application.
The last aim of this study is to study whether there is a relation between
cosmetic outcome after removal of an ICVAD, and psychosocial consequences of
the scar.
Study design
Study design
The study is a prospective randomized multicenter trial with a pretest-posttest
control group design, and will be performed at the Pediatric Surgical Center
Amsterdam, located at the VU university medical center and the Emma Children*s
Hospital, AMC (EKZ), Amsterdam.
The study includes two experimental groups and one control group.
Group A Patients in group A will receive a silicone gel sheet for two months (8
weeks).
Group B Patients in group B will receive a silicone gel sheet for six months
(28 weeks).
Group C Patients in group C do not get a silicone gel sheet.
The study will be continued until 36 evaluable patients are included.
Intervention
Intervention.
The application of a silicone gel sheet to optimize wound healing after removal
of the ICVAD, and to reduce the size of the scar.
Study burden and risks
Out of the children who participate in the study, two-third receive a silicone
gel sheet. The duration of application differs from 8 weeks in the first group
to 28 weeks in the other intervention group. During these weeks the silicone
gel sheet is used for about 20 to 24 hours per day. There is a control group
which does not get an intervention.
The silicone gel sheet presumably results in better scar outcome. A burden of
being in the intervention group can be the discomfort by using and removing the
silicone gel sheet from the skin. Sometimes rash is seen as a site effect of
the silicone gel sheet use. But personal hygiene may minimize the change for
getting rash.
De Boelelaan 1117
1081 HV Amsterdam
Nederland
De Boelelaan 1117
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Children between one and 18 years old, who are in follow-up for cancer treatment, and have an implanted central venous access device (ICVAD), which is planned to be removed.
Exclusion criteria
1. The implanted central venous access device (ICVAD) is located on an other location than the chest wall.
2. The ICVAD will be removed because of an infection.
3. The child received radiotherapy on the chest.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL13175.029.06 |