Back to resultsEffectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.
Primary Purpose
Hematoma, Surgical Wound, Surgery
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Khat leaves
Sponsored by
About this trial
This is an interventional treatment trial for Hematoma focused on measuring Oculoplastic Surgery, Khat leaves, Post operative care, Edema, Hematoma
Eligibility Criteria
Inclusion Criteria:
- Patients who underwent blepharoplasty and/or ptosis repair
Exclusion Criteria:
- Patients who were operated on one eye only
- Patients who underwent a different surgery in each eye
Sites / Locations
- Sheba_Medical_Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients after Oculoplastic surgery
Arm Description
Each 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.
Outcomes
Primary Outcome Measures
Edema
Improvement in edema in the Khat compression in comparison to standard compression by clinical evaluation.
Hematoma
Improvement in hematomas in the Khat compression in comparison to standard by compression by clinical evaluation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03917641
Brief Title
Effectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.
Official Title
Effectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematoma, Surgical Wound, Surgery, Eye Bruise, Edema
Keywords
Oculoplastic Surgery, Khat leaves, Post operative care, Edema, Hematoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each participant is his own control
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients after Oculoplastic surgery
Arm Type
Experimental
Arm Description
Each 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.
Intervention Type
Biological
Intervention Name(s)
Khat leaves
Intervention Description
One of the two compressions (one per each eye) the patient will use will contain the Khat leaves.
Primary Outcome Measure Information:
Title
Edema
Description
Improvement in edema in the Khat compression in comparison to standard compression by clinical evaluation.
Time Frame
7 days post op
Title
Hematoma
Description
Improvement in hematomas in the Khat compression in comparison to standard by compression by clinical evaluation.
Time Frame
7 days post op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients who underwent blepharoplasty and/or ptosis repair
Exclusion Criteria:
Patients who were operated on one eye only
Patients who underwent a different surgery in each eye
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guy J Ben Simon, MD
Phone
97235302874
Email
guybensimon@gmail.com
Facility Information:
Facility Name
Sheba_Medical_Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27429228
Citation
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.
Results Reference
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Learn more about this trial
Effectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.
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