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

April 13, 2019 updated by: Sheba Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Ramat Gan, Israel, 52621
        • Sheba_Medical_Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edema
Time Frame: 7 days post op
Improvement in edema in the Khat compression in comparison to standard compression by clinical evaluation.
7 days post op
Hematoma
Time Frame: 7 days post op
Improvement in hematomas in the Khat compression in comparison to standard by compression by clinical evaluation.
7 days post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

April 13, 2019

First Posted (Actual)

April 17, 2019

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 13, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-17-4804-GBS-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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