Clinical trial NCT04119297: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neurological Disorder
Nursing Caries
Periorbital Edema
Ecchymosis
Cryotherapy Effect
Keywords: Cold application
Craniotomy
Heparinoid
Periorbital edema
Periorbital ecchymosis
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2019-10-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Periorbital edema
timeFrame: Evaluation was performed twice a day for three days after craniotomy.
measure: Periorbital ecchymosis
timeFrame: Evaluation was performed twice a day for three days after craniotomy.
Secondary outcomes:
measure: Periorbital superficial skin temperature
timeFrame: Skin temperature was measured every hour before and after cold application
Other outcomes:
Locations:
Study officials:
affiliation: Necmettin Erbakan University
name: Serpil Yüksel, PhD
role: PRINCIPAL_INVESTIGATOR
References: