Efficacy of Arnica D1 Ointment After Upper Blepharoplasty

Not Applicable

Completed

• Conditions: Blepharoplasty; Upper Eyelid Blepharoplasty
• Interventions: Drug: Placebo ointment; Drug: Arnica

• Registration Number: NCT01598909
• Lead Sponsor: Wynand BWH Melenhorst, MD

Brief Summary

Arnica ointment is currently used in homeopathic preparations for strains and bruises. In the field of plastic surgery, some surgeons advise patients undergoing blepharoplasty to use Arnica in order to prevent postoperative ecchymosis, swelling and pain. Thus far, no decent study evaluated the efficacy of topical Arnica ointment in reducing ecchymosis or surgical outcome after upper blepharoplasty. We hypothesize that application of Arnica ointment postoperatively will reduce the development of ecchymosis and improve outcome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-12
• Study First Submitted QC: 2012-05-12
• Study First Posted: 2012-05-15
• Study Start: 2013-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-21
• Last Update Posted: 2015-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• patients undergoing primary blepharoplasty

Exclusion Criteria

• use of anticoagulants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo ointment	Placebo ointment	-
Arnica ointment	Arnica	-

Primary Outcome Measures

Name	Time	Method
Surgical outcome	7 days and 6 weeks postoperatively	Overall judgment of surgical outcome, based on the combined analysis of the amount of ecchymosis, swelling and redness, by an unrelated, uninvolved and "blinded" plastic surgeon.

Secondary Outcome Measures

Name	Time	Method
amount of tissue swelling; redness; pain; postoperative recovery; patient satisfaction	3, 7 and 42 days postoperatively

Trial Locations

Locations (1)

Isala Klinieken; 🇳🇱 Zwolle, Netherlands