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NCT Number: NCT04119297

Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis

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.

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Key information

Conditions

Neurological Disorder Blood Coagulation Disorders Cellulitis Connective Tissue Diseases Cryotherapy Effect Ecchymosis Eye Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Nervous System Diseases Nursing Caries Orbital Cellulitis Orbital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periorbital Edema Signs and Symptoms Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application

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

Other names: 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

Other names: local heparinoid application

Primary outcomes

  1. Periorbital edema

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

    This edema defined as swelling around the eye was evaluated using the Kara & Gokalan's Scale.

  2. Periorbital ecchymosis

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

    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 outcomes

  1. Periorbital superficial skin temperature

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

    Change in periorbital superficial skin temperature after cold application

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Collaborators

  • Istanbul University

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 8, 2019
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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