Effectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.
1 other identifier
interventional
10
1 country
1
Brief Summary
The post operative routine after Oculoplastic Surgery includes usage of cold compressions for symptomatic relief and decreasing of the edema and local hematomas in the first few days after the surgery. Khat (Catha edulis) is a plant that is used mainly for chewing and has a known stimulating effect, some patients report major improvement after including these leaves in the compressions they use after surgery. Khat contains the chemical ingredients Cathine and Cathinone, which are amphetamine-like alkaloids and probably the main contributors for its active effects. Our main goal is to use compressions that include the Khat leaves and check their effect on reducing the edema and hematomas after oculoplastic surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2019
CompletedFirst Posted
Study publicly available on registry
April 17, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedApril 17, 2019
April 1, 2019
1 year
April 1, 2019
April 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Edema
Improvement in edema in the Khat compression in comparison to standard compression by clinical evaluation.
7 days post op
Hematoma
Improvement in hematomas in the Khat compression in comparison to standard by compression by clinical evaluation.
7 days post op
Study Arms (1)
Patients after Oculoplastic surgery
EXPERIMENTALEach participant will use one compression with Khat leaves and another standard compression and will decide on which eye to use which compression. The compressions will be used for 10 minutes per every waking hour in the first 2 days post-op. The patient will take pictures of both his eyes in days 1,3 and 7 post operative days.
Interventions
One of the two compressions (one per each eye) the patient will use will contain the Khat leaves.
Eligibility Criteria
You may qualify if:
- Patients who underwent blepharoplasty and/or ptosis repair
You may not qualify if:
- Patients who were operated on one eye only
- Patients who underwent a different surgery in each eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba_Medical_Center
Ramat Gan, 52621, Israel
Related Publications (1)
Malhotra R, Ziahosseini K, Poitelea C, Litwin A, Sagili S. Effect of Manuka Honey on Eyelid Wound Healing: A Randomized Controlled Trial. Ophthalmic Plast Reconstr Surg. 2017 Jul/Aug;33(4):268-272. doi: 10.1097/IOP.0000000000000743.
PMID: 27429228BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2019
First Posted
April 17, 2019
Study Start
July 1, 2019
Primary Completion
July 1, 2020
Study Completion
July 1, 2021
Last Updated
April 17, 2019
Record last verified: 2019-04