Neurological DisorderNCT04119297
Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis
A study testing Routine care, Cold gel pack and Heparinoids Topical Cream in people with Neurological Disorder and Nursing Caries, run by Necmettin Erbakan University.
Trial summary
During surgery, blood leaking from damaged blood vessels spread to the periorbital area may cause periorbital edema and ecchymosis after anterior craniotomy. This study was carried out to determine the effects of the cold application and the local heparinoid on periorbital edema and ecchymosis after craniotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Disorder, Nursing Caries, Periorbital Edema
- What is being tested?
- Routine care, Cold gel pack and Heparinoids Topical Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2009to 1 Jul 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- who were aged 18 years and older
- who had Glasgow Coma Scale score > 15
- who had no mental and physical problems that interfere with communication
- whose vital signs were normal
- who had no ptosis
- who volunteered to participate and signed the informed consent form
Show all 11Show fewer
- Exclusion Criteria:The participants excluded from the study;
- who had Glasgow Coma Scale score < 15
- who died during surgery
- ptosis formed after surgery
- who refused to participate
Who cannot join
None listed.
About this study
Official title: Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis After Craniotomy
During surgery, blood leaking from damaged blood vessels spread to the periorbital area may cause periorbital edema and ecchymosis after anterior craniotomy. This study was carried out to determine the effects of the cold application and the local heparinoid on periorbital edema and ecchymosis after craniotomy.
Read the detailed description
Periorbital edema and ecchymosis are common after anterior craniotomy. Periorbital edema and ecchymosis are not complications, they are natural outcomes of surgical trauma. However, periorbital edema prevents pupil examination and causes the patient to experience fear and anxiety with accompanying ecchymosis. Periorbital edema rate after anterior craniotomy was 36.8-100%, ecchymosis rate was 62.5%, and 30% of patients with edema did not have a pupil examination for the first 36 hours after craniotomy.The present study was carried out to determine the effects of the heparinoid creams and regular cold application performed using gel packs in controlling periorbital edema and ecchymosis after craniotomy.
- Being tested
- Routine care, Cold gel pack, Heparinoids Topical Cream
- Keywords
- Cold application, Craniotomy, Heparinoid, Periorbital edema, Periorbital ecchymosis
- Medical subject headings
- Nervous System Diseases, Orbital Cellulitis, Ecchymosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine careOther
Also called Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application
- Routine care was applied to the periorbital area by clinical nurses.
- Periorbital edema, upper and lower eyelid ecchymosis of the patients were evaluated on the 3rd and 9th hours after craniotomy, and on the 1st, 2nd and 3rd days (twice daily) using the Kara \& Gokalan's Scale
Cold gel packOther
Also called Cold application
- Cold application was applied to the periorbital area for 20 minutes per hour beginning 3rd hour following craniotomy, except from 10pm-7 am, and for three days using gel pack cooled to -14ºC.
- Periorbital edema, upper and lower eyelid ecchymosis of the patients were evaluated on the 3rd and 9th hours after craniotomy, and on the 1st, 2nd and 3rd days (twice daily) using the Kara \& Gokalan's Scale
Heparinoids Topical CreamDrug
Also called local heparinoid application
- Heparinoid cream was applied to the periorbital area once at 3rd and 9th hours following craniotomy, and 4 times daily in the following 3 days.
- Periorbital edema, upper and lower eyelid ecchymosis of the patients were evaluated on the 3rd and 9th hours after craniotomy, and on the 1st, 2nd and 3rd days (twice daily) using the Kara \& Gokalan's Scale
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Routine care (Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application) of the clinic was applied. Receives: Other: Routine care |
| Cold application | Experimental | Cold application was applied for three days after craniotomy. Receives: Other: Cold gel pack |
| Heparinoid group | Experimental | Heparinoid cream was applied for three days after craniotomy Receives: Drug: Heparinoids Topical Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periorbital edema
This edema defined as swelling around the eye was evaluated using the Kara \& Gokalan's Scale.
Measured: Evaluation was performed twice a day for three days after craniotomy.
Periorbital ecchymosis
This ecchymosis is produced by blood tracking into periorbital tissues, causing blue or purple discoloration of the upper and lower eyelid. Evaluation was performed with using the Kara \& Gokalan's Scale.
Measured: Evaluation was performed twice a day for three days after craniotomy.
Secondary outcomes (1)
Periorbital superficial skin temperature
Change in periorbital superficial skin temperature after cold application
Measured: Skin temperature was measured every hour before and after cold application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 Oct 2009
- Primary completion1 Jul 2011
- Study completion1 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DisorderStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was conducted as a prospective, parallel, three arm (1:1:1), randomized controlled clinical trial at neurosurgical intensive care units (NICU) and neurosurgical clinics in two medical faculty hospital of a university in Istanbul, Turkey.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Serpil Yüksel, Necmettin Erbakan University
- Investigators
- Serpil Yüksel, PhD, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119297
- Sponsor's protocol ID
- 3791
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis After Craniotomy
- ClinicalTrials.gov ID
- NCT04119297
- Acronym / sponsor ID
- 3791
- Keywords
- Cold application, Craniotomy, Heparinoid, Periorbital edema, Periorbital ecchymosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 1 Oct 2009 (actual)
- Primary completion
- 1 Jul 2011 (actual)
- Study completion
- 1 Jul 2011 (actual)
- First posted
- 8 Oct 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.
During surgery, blood leaking from damaged blood vessels spread to the periorbital area may cause periorbital edema and ecchymosis after anterior craniotomy. This study was carried out to determine the effects of the cold application and the local heparinoid on periorbital edema and ecchymosis after craniotomy.
Detailed description
Periorbital edema and ecchymosis are common after anterior craniotomy. Periorbital edema and ecchymosis are not complications, they are natural outcomes of surgical trauma. However, periorbital edema prevents pupil examination and causes the patient to experience fear and anxiety with accompanying ecchymosis. Periorbital edema rate after anterior craniotomy was 36.8-100%, ecchymosis rate was 62.5%, and 30% of patients with edema did not have a pupil examination for the first 36 hours after craniotomy.The present study was carried out to determine the effects of the heparinoid creams and regular cold application performed using gel packs in controlling periorbital edema and ecchymosis after craniotomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This study was conducted as a prospective, parallel, three arm (1:1:1), randomized controlled clinical trial at neurosurgical intensive care units (NICU) and neurosurgical clinics in two medical faculty hospital of a university in Istanbul, Turkey.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Routine careRoutine care (Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application) of the clinic was applied. |
| Cold application | Experimental | Other: Cold gel packCold application was applied for three days after craniotomy. |
| Heparinoid group | Experimental | Drug: Heparinoids Topical CreamHeparinoid cream was applied for three days after craniotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- who were aged 18 years and older
- who had Glasgow Coma Scale score > 15
- who had no mental and physical problems that interfere with communication
- whose vital signs were normal
- who had no ptosis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Routine careAlso: Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application* Routine care was applied to the periorbital area by clinical nurses. * Periorbital edema, upper and lower eyelid ecchymosis of the patients were evaluated on the 3rd and 9th hours after craniotomy, and on the 1st, 2nd and 3rd days (twice daily) using the Kara \& Gokalan's Scale | Other | Control |
| Cold gel packAlso: Cold application* Cold application was applied to the periorbital area for 20 minutes per hour beginning 3rd hour following craniotomy, except from 10pm-7 am, and for three days using gel pack cooled to -14ºC. * Periorbital edema, upper and lower eyelid ecchymosis of the patients were evaluated on the 3rd and 9th hours after craniotomy, and on the 1st, 2nd and 3rd days (twice daily) using the Kara \& Gokalan's Scale | Other | Cold application |
| Heparinoids Topical CreamAlso: local heparinoid application* Heparinoid cream was applied to the periorbital area once at 3rd and 9th hours following craniotomy, and 4 times daily in the following 3 days. * Periorbital edema, upper and lower eyelid ecchymosis of the patients were evaluated on the 3rd and 9th hours after craniotomy, and on the 1st, 2nd and 3rd days (twice daily) using the Kara \& Gokalan's Scale | Drug | Heparinoid group |
Primary outcome
Periorbital edema
Time frame: Evaluation was performed twice a day for three days after craniotomy.
This edema defined as swelling around the eye was evaluated using the Kara \& Gokalan's Scale.
Periorbital ecchymosis
Time frame: Evaluation was performed twice a day for three days after craniotomy.
This ecchymosis is produced by blood tracking into periorbital tissues, causing blue or purple discoloration of the upper and lower eyelid. Evaluation was performed with using the Kara \& Gokalan's Scale.
1 secondary outcome
Periorbital superficial skin temperature
Time frame: Skin temperature was measured every hour before and after cold application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Serpil Yüksel, PhD principal investigator
Necmettin Erbakan University
Questions about this trial
What is this clinical trial studying?
A study testing Routine care, Cold gel pack and Heparinoids Topical Cream in people with Neurological Disorder and Nursing Caries, run by Necmettin Erbakan University.
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 11 inclusion and 0 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: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periorbital edema (time frame: Evaluation was performed twice a day for three days after craniotomy.). 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?
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 8 Oct 2019.