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OpenTrials
Completed

NCT Number: NCT01598909

Efficacy of Arnica D1 Ointment After Upper Blepharoplasty

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.

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Key information

Conditions

Blepharoplasty Upper Eyelid Blepharoplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isala Klinieken

Zwolle, 8000 GK, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing primary blepharoplasty

Exclusion criteria

  • use of anticoagulants

Treatment and study plan

Arnica

Drug

Application of Arnica ointment periorbitally

Placebo Ointment

Drug

Application of Arnica ointment, twice a day, for the period of one week.

Primary outcomes

  1. Surgical outcome

    Time frame: 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 outcomes

  1. amount of tissue swelling; redness; pain; postoperative recovery; patient satisfaction

    Time frame: 3, 7 and 42 days postoperatively

Sponsors and collaborators

Lead sponsor

Wynand BWH Melenhorst, MD

Other

Registry information

Official study title

Efficacy of Arnica D1 Ointment After Upper Blepharoplasty: a Randomized, Double-blind Placebo-controlled Study

Acronym: ARINE

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 15, 2012
Registry last updated
Aug 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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