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| Name | Class |
|---|---|
| Istanbul University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Cold application | Experimental | Cold application was applied for three days after craniotomy. |
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| Heparinoid group | Experimental | Heparinoid cream was applied for three days after craniotomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine care | Other |
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| 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. |
| 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 |
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Inclusion Criteria: The eligible participants were those
Exclusion Criteria:The participants excluded from the study;
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| Name | Affiliation | Role |
|---|---|---|
| Serpil YĂŒksel, PhD | Necmettin Erbakan University | Principal Investigator |
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D054517 | Orbital Cellulitis |
| D004438 | Ecchymosis |
| ID | Term |
|---|---|
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D002481 | Cellulitis |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007552 | Isotonic Solutions |
| ID | Term |
|---|---|
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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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.
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The random allocation cards was developed using a computer generated random number by a biostatistician who was not associated with the study. Group allocation was concealed using individual sealed opaque envelopes. As patients were enrolled in the study, the next envelope was extracted and the patients was assigned to the groups accordingly. When the patient was transferred from the operating theatre to the NICU or clinic, the nurse in the study (NA) assigned the patient to one of the groups according to the list in the envelope. Other investigator nurse (SY), two observer nurses (DG, YT), and all patients were blinded from group assignment. Also, all patients were blinded to all measurements and, the investigator and two observers were blinded to each other's measurements.
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| Cold gel pack | Other |
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| Heparinoids Topical Cream | Drug |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |