To evaluate the efficacy of Arnica om postoperative outcome after upper blepharoplasty.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The overall judgment of an unrelated, uninvolved, and blinded-to-treatment
plastic surgeon, at week 1 and 6 after blepharoplasty. This plastic surgeon
will score both eyelids for the amount of swelling, ecchymosis, redness. On
basis of these data, he/she will come to a judgment as to whether one of the
eyelids has achieved a superior outcome (eg, no difference vs. left eyelid
looks superior vs. righht eyelid looks superior). When a mark of superior
outcome coincides with an eyelid of treatment, this is considered a positive
treatment outcome.
Secondary outcome
Intra-individuel differences between eyelids, with regard to redness,
ecchymosis, swelling and pain (day 3, week 1 and week 6), patients satisfaction
with postoperative recovery (week 6) and patient satisfacton with regard to
postoperative outcome (week 6).
Background summary
• Arnica is currently used in homeopathic preparations for strains and bruises.
• Some plastic surgeons advise patients undergoing blepharoplasty to use Arnica
in order to prevent postoperative ecchymosis
• No decent study evaluated the efficacy of topical Arnica ointment after upper
blepharoplasty.
Study objective
To evaluate the efficacy of Arnica om postoperative outcome after upper
blepharoplasty.
Study design
• Monocenter study: department of plastic surgery, Isala Klinieken Zwolle
• Prospective, randomized, double-blind, placebo-controlled
• Surgeons: plastic surgeons and residents in plastic surgery with expertise in
blepharoplasty (record of at least 30 upper blepharoplasties).
• Operative procedure: standardized blepharoplasty pocedure
Intervention
• Two study arms:
1. Application of Arnica ointment to one eyelid, and no treatment of the other
eyelid
2. Application of Placebo ointment to one eyelid, and no treatment of the other
eyelid
• Treatment: periorbital application of Arnica or placebo ointment
(double-blind) to one eyelid twice a day, on day 0, 1, 2, 3, 4, 5, 6 (with *0*
being day of surgery)
Study burden and risks
Study participants are exposed to an extra 5-15 minutes in their preoperative
counseling consult. Moreover, they undergo two additional checkings of 15
minutes (to complete a questionnaire and to take light photographs).
There is an additional 5-15 minutes at the time of operation, to allow for
completing a questionnaire.
Study-related risks:
- Increased risk of pain as a consequence of applying ointment to a recently
operated area.
- (Minimally) increased risk of infection as a consequence of applying ointment
to a recently operated area
Dokter van Heesweg 2
Zwolle 8000 GK
NL
Dokter van Heesweg 2
Zwolle 8000 GK
NL
Listed location countries
Age
Inclusion criteria
All patients undergoing a primary upper blepharoplasty, aged 18 years or older.
Exclusion criteria
Use of anticoagulant medication.
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 | EUCTR2012-000847-28-NL |
| CCMO | NL39916.075.12 |
| Other | NTC01598909 |