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临床试验/NCT05353374
NCT05353374已完成不适用

Effectiveness of Sodium Fusidate Ointment Compared to Petrolatum for Wound Healing Following Cauterization: A Double-Blind Randomized Controlled Trial

Indonesia University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Wound healing score

研究概览

简要总结

A double-blind within person randomized controlled trial study was conducted on 90 wounds in 22 subjects. All wounds were randomized to receive either sodium fusidate ointment or petrolatum following cauterization.

详细描述

All eligible participants were randomized to be applied sodium fusidate ointment (intervention) or white petrolatum (control) on the lesions on their face with 1:1 ratio. Allocation sequence was generated by a statistician with a computer and it was concealed from the researchers and participants. The ointment was prepared and packaged by a pharmacist. Each pot was numbered in accordance with the allocation sequence.

Electrosurgery was carried out using Ellman® Surgitron. Prior to the cauterization, we performed infiltration anesthesia around the lesion with Pehacain® (containing 20 mg of lidocaine and 0.0125 mg/ml epinephrine). The tissue was cleaned using sterile gauze or a cotton swab that had been moistened with 0.9% NaCl. Following electrosurgery, sodium fusidate ointment or petrolatum was applied to the wound according to the allocation sequence. The patient also received a wound care instruction sheet. This sheet contained information on how to wash the face or body properly, how to apply the ointment properly, what to avoid after procedure (rubbing the wound excessively, use make up, sweating excessively, and use other topical agents on the wound), and follow-up instructions (on the 3rd, 7th, and 14th day). Each subject was given two or four pots of ointment that should be applied twice daily on the wound.

Wound monitoring, which includes erythema, edema, crusting, re-epithelialization, total wound healing score, pus, and subjective symptoms was performed on the 3rd, 7th, and 14th day. Erythema scores was also monitored immediately after electrosurgery. Monitoring can be done 1 day earlier or later than schedule in some cases since the wound healing phase is expected still the same. Clinical grading of each site was carried out using a 5-point analog scale for erythema, edema, crusting, re-epithelialization, and total wound healing score.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Allocation sequence was generated by a statistician with a computer and it was concealed from the researchers and participants. The ointment was prepared and packaged by a pharmacist. Each pot was numbered in accordance with the allocation sequence.

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 20 years
  • clinically diagnosed with seborrheic keratosis or acrochordon
  • having minimum of two lesions and maximum of four lesions with diameter of 4-10 mm on face or neck and minimum distance between lesions of 5 cm
  • providing consent to participate into the study

排除标准

  • a skin bacterial infection on the other parts of body's skin
  • benign tumor lesions with inflammation or secondary infection
  • history of antibiotics use in the last 2 weeks or long-acting penicillin injections within the past 1 month
  • history of corticosteroids and immunosuppressants use in the past 2 weeks
  • using a pacemaker
  • infected with Coronavirus disease 2019 (Covid-19).

研究组 & 干预措施

Sodium fusidate ointment

Experimental

Electrosurgery was carried out using Ellman® Surgitron. The tissue was cleaned using sterile gauze or a cotton swab that had been moistened with 0.9% NaCl. Following electrosurgery, sodium fusidate ointment was applied to the wound according to the allocation sequence. The patient also received a wound care instruction sheet. Each subject was given two or four pots of ointment that should be applied twice daily on the wound.

干预措施: Sodium Fusidate 2 % Topical Ointment (Drug)

Petrolatum

Placebo Comparator

Electrosurgery was carried out using Ellman® Surgitron. The tissue was cleaned using sterile gauze or a cotton swab that had been moistened with 0.9% NaCl. Following electrosurgery, petrolatum was applied to the wound according to the allocation sequence. The patient also received a wound care instruction sheet. Each subject was given two or four pots of ointment that should be applied twice daily on the wound.

干预措施: Petrolatum ointment (Drug)

结局指标

主要结局

Wound healing score

时间窗: 14 days

Wound healing score was calculated based on the erythema, edema, crusts, and reepithelization. Wound healing score is as follows: 0-4 = very good/healed, 5-8 good/healed, 9-12 moderate/not healed, and 13-16 = poor/not healed

次要结局

  • Erythema(14 days)
  • Edema(14 days)
  • Crusts(14 days)
  • Reepithelization(14 days)
  • Incidence of infection(14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Firman Parrol

Dermatology Resident

Indonesia University

研究点 (1)

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