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CompletedNCT04119297Updated Oct 8, 2019

Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis

An interventional study of Routine care and Cold gel pack in Neurological Disorder, Nursing Caries and Periorbital Edema, sponsored by Necmettin Erbakan University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-08.

Sponsored by Necmettin Erbakan University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 10 years after the study started (first participant enrolled Oct 2009, registered Oct 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Cold application
  • Craniotomy
  • Heparinoid
  • Periorbital edema
  • Periorbital ecchymosis
03

In context

Nervous System Diseases

757 studies on the registry are indexed under Nervous System Diseases; 218 are open to participants now.

This study's enrollment of 90 is above the median of 55 across 495 interventional studies indexed under Nervous System Diseases.

Browse Nervous System Diseases studies →

Lead sponsor

Necmettin Erbakan University is the lead sponsor of 201 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (actual)

Study arms

  • 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

  • Experimental
    Cold application

    Cold application was applied for three days after craniotomy.

    Other: Cold gel pack

  • Experimental
    Heparinoid group

    Heparinoid cream was applied for three days after craniotomy

    Drug: Heparinoids Topical Cream

Interventions

  • OtherRoutine 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

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

  • OtherCold 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

    Also known as: Cold application

  • DrugHeparinoids 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

    Also known as: local heparinoid application

06

What researchers measure

Primary outcomes

  1. Periorbital edema

    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.

  2. 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.

    Time frame: Evaluation was performed twice a day for three days after craniotomy.

Secondary outcomes

  1. Periorbital superficial skin temperature

    Change in periorbital superficial skin temperature after cold application

    Time frame: Skin temperature was measured every hour before and after cold application

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04119297
Collaborators
Istanbul University
Responsible party
Serpil Yüksel (Assistant Professor, Necmettin Erbakan University) — Principal investigator
First posted
Oct 8, 2019
Start date
Oct 1, 2009
Primary completion
Jul 1, 2011
Completion
Jul 1, 2011
Last update
Oct 8, 2019

Study contacts

Serpil Yüksel, PhD
principal investigator · Necmettin Erbakan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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