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Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04119297
Enrollment
90
Registered
2019-10-08
Start date
2009-10-01
Completion date
2011-07-01
Last updated
2019-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Cold application, Craniotomy, Heparinoid, Periorbital edema, Periorbital ecchymosis

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.

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

* 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

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

Sponsors

Istanbul University
CollaboratorOTHER
Necmettin Erbakan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

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.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Periorbital edemaEvaluation 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.
Periorbital ecchymosisEvaluation 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

MeasureTime frameDescription
Periorbital superficial skin temperatureSkin temperature was measured every hour before and after cold applicationChange in periorbital superficial skin temperature after cold application

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026