Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-01

Study Completion Date

2011-07-01

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.

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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.

Conditions

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Neurological Disorder Nursing Caries Periorbital Edema Ecchymosis Cryotherapy Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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Control

Routine care (Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application) of the clinic was applied.

Group Type ACTIVE_COMPARATOR

Routine care

Intervention Type OTHER

* 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 application

Cold application was applied for three days after craniotomy.

Group Type EXPERIMENTAL

Cold gel pack

Intervention Type OTHER

* 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

Heparinoid group

Heparinoid cream was applied for three days after craniotomy

Group Type EXPERIMENTAL

Heparinoids Topical Cream

Intervention Type DRUG

* 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

Interventions

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Routine care

* 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

Intervention Type OTHER

Cold gel pack

* 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

Intervention Type OTHER

Heparinoids Topical Cream

* 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

Intervention Type DRUG

Other Intervention Names

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Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application Cold application local heparinoid application

Eligibility Criteria

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Inclusion Criteria

* 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