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Effectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03917641
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Hematoma Surgical Wound Surgery Eye Bruise Edema Biological: Khat leaves Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Each participant is his own control
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients after Oculoplastic surgery

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.

Biological: Khat leaves
One of the two compressions (one per each eye) the patient will use will contain the Khat leaves.




Primary Outcome Measures :
  1. Edema [ Time Frame: 7 days post op ]
    Improvement in edema in the Khat compression in comparison to standard compression by clinical evaluation.

  2. Hematoma [ Time Frame: 7 days post op ]
    Improvement in hematomas in the Khat compression in comparison to standard by compression by clinical evaluation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917641


Contacts
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Contact: Guy J Ben Simon, MD 97235302874 guybensimon@gmail.com

Locations
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Israel
Sheba_Medical_Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Publications:
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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT03917641    
Other Study ID Numbers: SHEBA-17-4804-GBS-CTIL
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sheba Medical Center:
Oculoplastic Surgery
Khat leaves
Post operative care
Edema
Hematoma
Additional relevant MeSH terms:
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Hematoma
Wounds and Injuries
Surgical Wound
Hemorrhage
Pathologic Processes