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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
Necmettin Erbakan University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 2, 2019
    Last Updated
    October 7, 2019
    Sponsor
    Necmettin Erbakan University
    Collaborators
    Istanbul University
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    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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