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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

Tracking Information
First Submitted Date  ICMJE April 1, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date April 17, 2019
Estimated Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2019)
  • Edema [ Time Frame: 7 days post op ]
    Improvement in edema in the Khat compression in comparison to standard compression by clinical evaluation.
  • Hematoma [ Time Frame: 7 days post op ]
    Improvement in hematomas in the Khat compression in comparison to standard by compression by clinical evaluation.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.
Official Title  ICMJE Effectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Each participant is his own control
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hematoma
  • Surgical Wound
  • Surgery
  • Eye Bruise
  • Edema
Intervention  ICMJE Biological: Khat leaves
One of the two compressions (one per each eye) the patient will use will contain the Khat leaves.
Study Arms  ICMJE 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.

Intervention: Biological: Khat leaves
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2021
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Guy J Ben Simon, MD 97235302874 guybensimon@gmail.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03917641
Other Study ID Numbers  ICMJE SHEBA-17-4804-GBS-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sheba Medical Center
Study Sponsor  ICMJE Sheba Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sheba Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP