The primary objective of this research is to compare pain experience and comfort when a calcium alginate or Suprathel® is used on the donor site. Secondary objectives are the differences in scarring, itching of the scar tissue and costs involved…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference in pain experience and comfort
between Suprathel® and a calcium alginate.
Secondary outcome
Secondary study parameters are the differences in costs, scarring and itching
of scar tissue between Suprathel® and a calcium alginate.
Background summary
Calcium alginates are frequently used as wound dressings to cover up
split-thickness skin graft (STSG) donor sites. The main disadvantage of calcium
alginates is the amount of pain experienced on the donor site during
mobilization and change of dressings.
Nowadays many new dressings are available. They all claim to decrease the donor
site pain during mobilization, but only one primary dressing, Suprathel®, does
not require dressing changes and can therefore decrease pain during change of
dressings. This research will try to answer the question, whether or not
Suprathel® can decrease donor site pain and increase comfort with regard to
calcium alginates.
Study objective
The primary objective of this research is to compare pain experience and
comfort when a calcium alginate or Suprathel® is used on the donor site.
Secondary objectives are the differences in scarring, itching of the scar
tissue and costs involved with the use of one of both dressings.
Study design
Single centre randomised controlled trial.
Intervention
After randomization half of the number of donor sites will be bound with
Suprathel® and the other half with a calcium alginate.
Study burden and risks
No (serious) adverse events are to be expected in the use of both bandages.
From the moment of surgery until discharge the patient will undergo a VAS score
for pain and comfort and a short survey once a day. Furthermore the patiënt
needs to fill in an EQ5D survey daily.
After discharge the patient will receive a patient diary. The patient will need
to fill in a pain and comfort survey and an EQ5D survey in this dairy, once a
day, until day 14 after surgery.
When the donor site wound is completely cured, the patient will need to fill in
a survey, once a week, up to four weeks. This survey needs to point out,
whether or not the patient still feels pain in the donor site and, if
applicable, the patient will need to fill in two more pain scores. When the
patient does not experience pain, the patient needs to answer the question,
whether or not itchiness is experienced in the donor site and, if applicable,
the patient will need to fill in two itch scores.
A follow-up appointment will be planned 3 months after surgery. During this
appointment the donor site will be assessed on scar tissue and one more pain or
itch score will be done.
This complete research will cost the patient a maximum of 2 hours and 15
minutes, exclusive of travel time. Travel time will be compensated.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
The patient is 18 years or above.
A STSG will be harvested from the patient's upperleg.
The patient signed the informed consent form.
Exclusion criteria
The STSG is harvested from any area other then the upperleg.
The STSG is harvested from a previous donorsite.
The patient has any mental limitation, which will compromise parts of the research.
The patient has any known allergies for one of the wound dressings or their ingredients.
The patient is not able to perceive pain, due to any sensibel impairment.
On medical grounds, the patient should not be treated with adrenaline dressings.
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 | NL28732.078.09 |