Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis After Craniotomy

Conditions
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Neurological Disorder, Nursing Caries, Periorbital Edema, Ecchymosis, Cryotherapy Effect

Intervention / Treatment
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* Other: Routine care
* Other: Cold gel pack
* Drug: Heparinoids Topical Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The eligible participants were those 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Routine care (Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application) of the clinic was applied. | Other: Routine care<br>* 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<br>* Other names: Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application;|
| Experimental: Cold application<br>Cold application was applied for three days after craniotomy. | Other: Cold gel pack<br>* 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<br>* Other names: Cold application;|
| Experimental: Heparinoid group<br>Heparinoid cream was applied for three days after craniotomy | Drug: Heparinoids Topical Cream<br>* 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<br>* Other names: local heparinoid application;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periorbital edema | This edema defined as swelling around the eye was evaluated using the Kara & Gokalan's Scale. | 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. | Evaluation was performed twice a day for three days after craniotomy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periorbital superficial skin temperature | Change in periorbital superficial skin temperature after cold application | Skin temperature was measured every hour before and after cold application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cold application, Craniotomy, Heparinoid, Periorbital edema, Periorbital ecchymosis