Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis

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

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.

Study Overview

• Status: Completed
• Conditions: Nursing Caries; Neurological Disorder; Ecchymosis; Cryotherapy Effect; Periorbital Edema
• Intervention / Treatment: Other: Routine care; Other: Cold gel pack; Drug: Heparinoids Topical Cream

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control; 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; 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; Other Names: Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application
EXPERIMENTAL: Cold application; Cold application was applied for three days after craniotomy.	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; Other Names: Cold application
EXPERIMENTAL: Heparinoid group; Heparinoid cream was applied for three days after craniotomy	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; Other Names: local heparinoid application

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University
• Collaborators: Istanbul University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2009
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (ACTUAL): October 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Cold application; Craniotomy; Heparinoid; Periorbital edema; Periorbital ecchymosis
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Hemorrhage; Blood Coagulation Disorders; Skin Manifestations; Nervous System Diseases; Edema; Ecchymosis; Anti-Inflammatory Agents; Anticoagulants; Heparinoids
• Other Study ID Numbers: 3791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No