Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis

Not Applicable

Completed

• Conditions: Neurological Disorder; Nursing Caries; Periorbital Edema; Ecchymosis; Cryotherapy Effect
• Interventions: Other: Routine care; Drug: Heparinoids Topical Cream; Other: Cold gel pack

• Registration Number: NCT04119297
• Lead Sponsor: Necmettin Erbakan University

Brief 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.

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 Timeline

• Study Start: 2009-10-01
• Primary Completion: 2011-07-01
• Study Completion: 2011-07-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-07
• Last Update Submitted: 2019-10-07
• Study First Posted: 2019-10-08
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Routine care	Routine care (Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application) of the clinic was applied.
Heparinoid group	Heparinoids Topical Cream	Heparinoid cream was applied for three days after craniotomy
Cold application	Cold gel pack	Cold application was applied for three days after craniotomy.

Primary Outcome Measures

Name	Time	Method
Periorbital edema	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	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.

Secondary Outcome Measures

Name	Time	Method
Periorbital superficial skin temperature	Skin temperature was measured every hour before and after cold application	Change in periorbital superficial skin temperature after cold application