Effects of Cold Application and Heparinoid on Periorbital Edema and Ecchymosis After Craniotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Periorbital edema
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
Routine care (Irregular cold application or gauze bandages wetted with isotonic solution or once daily heparinoid cream application) of the clinic was applied.
干预措施: Routine care (Other)
Cold application
Cold application was applied for three days after craniotomy.
干预措施: Cold gel pack (Other)
Heparinoid group
Heparinoid cream was applied for three days after craniotomy
干预措施: Heparinoids Topical Cream (Drug)
结局指标
主要结局
Periorbital edema
时间窗: 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.
Periorbital ecchymosis
时间窗: 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.
次要结局
- Periorbital superficial skin temperature(Skin temperature was measured every hour before and after cold application)
研究者
Serpil Yüksel
Assistant Professor
Necmettin Erbakan University