Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis

Nursing Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119297
• Other study ID #: 3791
• Status: Completed
• Phase: N/A
• Start date: October 1, 2009
• Est. completion date: July 1, 2011

Study information

• Verified date: October 2019
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 1, 2011
• Est. primary completion date: July 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cryotherapy Effect
• Ecchymosis
• Edema
• Nervous System Diseases
• Neurological Disorder
• Nursing Caries
• Periorbital Edema

Intervention

Other:
• 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
• 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

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Necmettin Erbakan University	Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Periorbital superficial skin temperature	Change in periorbital superficial skin temperature after cold application	Skin temperature was measured every hour before and after cold application