Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis
Primary Purpose
Neurological Disorder, Nursing Caries, Periorbital Edema
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Routine care
Cold gel pack
Heparinoids Topical Cream
Sponsored by
About this trial
This is an interventional prevention trial for Neurological Disorder focused on measuring Cold application, Craniotomy, Heparinoid, Periorbital edema, Periorbital ecchymosis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control
Cold application
Heparinoid group
Arm Description
Routine care (Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application) of the clinic was applied.
Cold application was applied for three days after craniotomy.
Heparinoid cream was applied for three days after craniotomy
Outcomes
Primary Outcome Measures
Periorbital edema
This edema defined as swelling around the eye was evaluated using the Kara & Gokalan's Scale.
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.
Secondary Outcome Measures
Periorbital superficial skin temperature
Change in periorbital superficial skin temperature after cold application
Full Information
NCT ID
NCT04119297
First Posted
October 2, 2019
Last Updated
October 7, 2019
Sponsor
Necmettin Erbakan University
Collaborators
Istanbul University
1. Study Identification
Unique Protocol Identification Number
NCT04119297
Brief Title
Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis
Official Title
Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis After Craniotomy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2009 (Actual)
Primary Completion Date
July 1, 2011 (Actual)
Study Completion Date
July 1, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Necmettin Erbakan University
Collaborators
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Disorder, Nursing Caries, Periorbital Edema, Ecchymosis, Cryotherapy Effect
Keywords
Cold application, Craniotomy, Heparinoid, Periorbital edema, Periorbital ecchymosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Routine care (Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application) of the clinic was applied.
Arm Title
Cold application
Arm Type
Experimental
Arm Description
Cold application was applied for three days after craniotomy.
Arm Title
Heparinoid group
Arm Type
Experimental
Arm Description
Heparinoid cream was applied for three days after craniotomy
Intervention Type
Other
Intervention Name(s)
Routine care
Other Intervention Name(s)
Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application
Intervention Description
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
Intervention Name(s)
Cold gel pack
Other Intervention Name(s)
Cold application
Intervention Description
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
Drug
Intervention Name(s)
Heparinoids Topical Cream
Other Intervention Name(s)
local heparinoid application
Intervention Description
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
Primary Outcome Measure Information:
Title
Periorbital edema
Description
This edema defined as swelling around the eye was evaluated using the Kara & Gokalan's Scale.
Time Frame
Evaluation was performed twice a day for three days after craniotomy.
Title
Periorbital ecchymosis
Description
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.
Time Frame
Evaluation was performed twice a day for three days after craniotomy.
Secondary Outcome Measure Information:
Title
Periorbital superficial skin temperature
Description
Change in periorbital superficial skin temperature after cold application
Time Frame
Skin temperature was measured every hour before and after cold application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serpil Yüksel, PhD
Organizational Affiliation
Necmettin Erbakan University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis
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