To evaluate the effectiveness, cost-effectiveness and quality of life of Flaminal® versus Flammazine® in the treatment of superficial and deep partial thickness burns.
ID
Source
Brief title
Condition
- Other condition
- Epidermal and dermal conditions
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Health condition
kwaliteit van leven
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is time to reach complete re-epithelialization (>95%) in days
of the largest partial thickness burn area (study area), judged by an
experienced burn specialist/ trained researcher.
Secondary outcome
-Clinical outcomes: Need for operation and percentage of TBSA of the study area
that needs operation, colonization rate, infection rate, use of systematic
antibiotics.
-Patients outcomes:
Pain and anxiety: Visual Analogue Thermometer (VAT) and Burn Specific Pain
Anxiety Scale (BSPAS) are used to evaluate pain and anxiety for the treatment.
Health related quality of life (HRQoL): Burn Specific Health Scale (BSHS) -
Dutch and EuroQol -5D questionnaire are evaluated 3, 6 and 12 months post burn
to evaluate HRQoL.
Scarring: Patient and Observer Scar Assessment Score (POSAS), cutometer to
measure scar elasticity and dermaspectometer to assess scar colour are used 3,
6 and 12 month post-burn to evaluate scarring.
-Cost-effectiveness: Medical and non-medical of both treatments are evaluated.
Background summary
Second degree (partial thickness) burns are painful, difficult to manage and
when deeper, have a negative effect on quality of life through scarring,
permanent disfigurement and loss of function. Thus, the aim of burn treatment
in partial thickness burns is to achieve wound healing, preferably without
surgery, as soon as possible to minimize scarring and loss of function of the
affected area. The treatment of partial thickness burns should also minimally
disturb wound healing by creating an optimum moist wound environment, have
debriding and analgesic effect, protect the wound from infection and be
convenient for the patient and care takers. However, there is no consensus on
the optimal treatment of partial thickness wounds. Flaminal® and Flammazine®
are two standard treatment options that provide the above mentioned properties
in burn treatment and have good results in the clinical practice. Nevertheless,
no randomized controlled study yet compared the effectiveness,
cost-effectiveness and quality of life of these two common treatment modalities
in partial thickness burns.
Study objective
To evaluate the effectiveness, cost-effectiveness and quality of life of
Flaminal® versus Flammazine® in the treatment of superficial and deep partial
thickness burns.
Study design
The study is designed as an open label, multi-center, randomized controlled
trial (RCT), evaluating the effectiveness, cost-effectivness and quality of
life of Flaminal® versus Flammazine® in patients with superficial and deep
partial thickness burns.
Intervention
Flaminal® Forte: The treatment with Flaminal® Forte (glucose
oxidase-lactoperoxidase-guaiacol complex in alginogel, FlenPharma) consists of
the application of Flaminal® Forte on admittance (within 48 hours of injury).
Flaminal® Forte is applied on a non-adhesive dressing. Finally a fixation
material is needed to keep the dressing in place. The burn wound is cleaned and
rinsed on each dressing change.
Dressing change is performed daily the first three days post-burn and then
every two days if desired until they are healed or treated surgically.
Flammazine®: The treatment with Flammazine® (silversulfadiazine 10 mg/g in
crème base, Centrafarm Pharmaceuticals) consists of the application of
Flammazine® on admittance (within 48 hours of injury). Flammazine® can be
applied directly on the wound. The cream layer is covered with a non-adhesive
dressing. Finally a net bandage/ dressing is needed to keep the dressing in
place. The cream should be re-applied every day till 5 post-burn. Thereafter,
the treatment consist of Furacine or Flammazine® on every other day until they
are healed or treated surgically.
Study burden and risks
Both treatments are applied in the Netherlands and considered standard
treatment. Therefore, there is no additional risk or discomfort for the
patient. The measurement and questionnaires during the fellow-up period are
performed during the usual out-patient appointments. The main disadvantage for
the patient thus is the investment of time.
Vondellaan 13
Beverwijk 1942LE
NL
Vondellaan 13
Beverwijk 1942LE
NL
Listed location countries
Age
Inclusion criteria
- Competent or temporary incompetent (because of sedation and/ or intubation) patients with partial thickness burns and/ or mixed depth of partial and full thickness burns
- Hospital admission within 48 hour of burn injury
- Written informed consent
Exclusion criteria
- Age < 18 years
- Total body surface area (TBSA) of > 30% (excluding head)
- Burns caused by chemicals, electricity or radiation
- Patients in whom local therapy with a topical agent has already started
- Patients who are expected (according to the responsible medical doctor) to be non-compliant to the study protocol
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 |
|---|---|
| EudraCT | EUCTR2013-000901-21-NL |
| CCMO | NL43671.094.13 |