Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis

NCT04119297 | Completed

• 1 other identifier: 3791
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neurological Disorder; Nursing Caries; Periorbital Edema; Ecchymosis; Cryotherapy Effect

Keywords

Cold application; Craniotomy; Heparinoid; Periorbital edema; Periorbital ecchymosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Periorbital superficial skin temperature

  Skin temperature was measured every hour before and after cold application

Study Arms (3)

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.

Other: Routine care

Cold application

EXPERIMENTAL

Cold application was applied for three days after craniotomy.

Other: Cold gel pack

Heparinoid group

EXPERIMENTAL

Heparinoid cream was applied for three days after craniotomy

Drug: Heparinoids Topical Cream

Interventions

Routine care 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

Also known as: Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application

Control

Cold gel pack 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

Also known as: Cold application

Cold application

Heparinoids Topical Cream 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

Also known as: local heparinoid application

Heparinoid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• who had Glasgow Coma Scale score \< 15
• who died during surgery
• ptosis formed after surgery
• who refused to participate

Sponsors & Collaborators

• Necmettin Erbakan University: lead
• Istanbul University: collaborator

MeSH Terms

Conditions

Nervous System Diseases; Orbital Cellulitis; Ecchymosis

Interventions

Isotonic Solutions

Condition Hierarchy (Ancestors)

Orbital Diseases; Eye Diseases; Cellulitis; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Solutions; Pharmaceutical Preparations

Study Officials

• Serpil Yüksel, PhD

  Necmettin Erbakan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 8, 2019
• Study Start: October 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share