HematomaNCT03917641
Effectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.
A study testing Khat leaves in people with Hematoma and Surgical Wound, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematoma, Surgical Wound, Surgery
- What is being tested?
- Khat leaves
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2019to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who underwent blepharoplasty and/or ptosis repair
Who cannot join
- Patients who were operated on one eye only
- Patients who underwent a different surgery in each eye
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hematoma, Surgical Wound, Surgery, Eye Bruise, Edema
- Being tested
- Khat leaves
- Keywords
- Oculoplastic Surgery, Khat leaves, Post operative care, Edema, Hematoma
- Medical subject headings
- Hematoma, Surgical Wound, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Khat leavesBiological
One of the two compressions (one per each eye) the patient will use will contain the Khat leaves.
| Study group | Role | What they receive |
|---|---|---|
| Patients after Oculoplastic surgery | Experimental | 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. Receives: Biological: Khat leaves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema
Improvement in edema in the Khat compression in comparison to standard compression by clinical evaluation.
Measured: 7 days post op
Hematoma
Improvement in hematomas in the Khat compression in comparison to standard by compression by clinical evaluation.
Measured: 7 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start1 Jul 2019 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HematomaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant is his own control
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917641
- Sponsor's protocol ID
- SHEBA-17-4804-GBS-CTIL
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 27429228
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Khat on Eyelid Wound Healing After Oculoplastic Surgery - a Prospective Study.
- ClinicalTrials.gov ID
- NCT03917641
- Acronym / sponsor ID
- SHEBA-17-4804-GBS-CTIL
- Conditions
- Hematoma, Surgical Wound, Surgery, Eye Bruise, Edema
- Keywords
- Oculoplastic Surgery, Khat leaves, Post operative care, Edema, Hematoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant is his own control
| Arm | Type | Receives |
|---|---|---|
| Patients after Oculoplastic surgery | Experimental | Biological: Khat leavesEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who underwent blepharoplasty and/or ptosis repair
Key exclusion criteria (2 listed)
- Patients who were operated on one eye only
- Patients who underwent a different surgery in each eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Khat leavesOne of the two compressions (one per each eye) the patient will use will contain the Khat leaves. | Biological | Patients after Oculoplastic surgery |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Background: PubMed 27429228Malhotra 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Khat leaves in people with Hematoma and Surgical Wound, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guy J Ben Simon, MD (97235302874, guybensimon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edema (time frame: 7 days post op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03917641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.