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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03917641
• Other study ID #: SHEBA-17-4804-GBS-CTIL
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: April 2019
• Source: Sheba Medical Center
• Contact: Guy J Ben Simon, MD
• Phone: 97235302874
• Email: guybensimon[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Eye Bruise
• Hematoma
• Surgery
• Surgical Wound
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Israel	Sheba_Medical_Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edema	Improvement in edema in the Khat compression in comparison to standard compression by clinical evaluation.	7 days post op
Primary	Hematoma	Improvement in hematomas in the Khat compression in comparison to standard by compression by clinical evaluation.	7 days post op