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临床试验/NCT07064161
NCT07064161已完成不适用

A Double-Blind Randomized Controlled Trial on the Efficacy of Hydrocolloid Dressing vs. Topical Antibiotic on Wound Healing of Post-Punch Biopsy Wounds Among Patients in a Tertiary Hospital in Manila

University of Santo Tomas Hospital, Philippines1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月29日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Absence or Presence of Infection

研究概览

简要总结

The main objective of this study is to determine the efficacy of using hydrocolloid dressing on wound healing of post-punch biopsy wounds vs topical antibiotic. Specifically, it aims to measure the following parameters: the presence or absence of infection, the clinical estimate of reepithelialization, the clinical estimate of wound closure, scar formation, pigmentation of scar, and the cosmetic appearance of the wound.

The study is a double-blind randomized controlled trial which will be conducted at the Dermatology outpatient department and the private clinics of dermatology consultants of the University of Santo Tomas Hospital. Patients who will be included are those who are 18 to 64 years of age with clean cutaneous lesions. Excluded from this study are those who have infected wounds, those who have conditions with poor tendency to heal including diabetes mellitus, peripheral vascular disease, history of keloid formation, those currently receiving anticoagulation therapy or systemic corticosteroids, and those known to have hypersensitivity to topical antibiotics.

The primary outcome measure is the proportion of patients who achieved better overall healing when treated with hydrocolloid dressing.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients 18 to 64 years old with clean cutaneous lesions who underwent skin punch biopsy using 3-mm disposable biopsy puncher.

排除标准

  • Patients with infected wounds.
  • Patients with conditions with poor tendency to heal including diabetes mellitus, peripheral vascular disease, history of keloid formation, patients currently receiving anticoagulation therapy or systemic corticosteroids.
  • Patients known to have hypersensitivity to topical antibiotics.

研究组 & 干预措施

Hydrocolloid Dressing

Experimental

Skin punch biopsy wound treated with hydrocolloid dressing.

干预措施: Hydrocolloid Dressing (DuoDERM CGF) (Drug)

Topical Antibiotic

Experimental

Skin punch biopsy wound treated with topical antibiotic.

干预措施: Mupirocin (drug) (Drug)

结局指标

主要结局

Absence or Presence of Infection

时间窗: 5 days after punch biopsy.

Absent - millimeters of surrounding erythema or equivocal findings Present - as inferred by indurated erythema or purulent discharge

Clinical Estimate of Reepithelialization

时间窗: 5 days after punch biopsy

Rated on a scale of: * 0% to 25% * 26% to 50% * 51% to 75% * 76% to 100%

Clinical Estimate of Wound Closure

时间窗: 5 days after punch biopsy

Rated on a scale of: * 0% to 25% * 26% to 50% * 51% to 75% * 76% to 100%

Scar Formation

时间窗: 5 days after punch biopsy

Select one of the following for the assessment: * Unhealed * Depressed or Atrophied * Normal fine-line scar * Hypertrophied scar or Keloid

Scar Pigmentation

时间窗: 5 days after punch biopsy

Select one of the following for the assessment: * Indeterminate or Unhealed * Normal * Hyperpigmented * Hypopigmented

Cosmetic Appearance

时间窗: 5 days after punch biopsy

Select one of the following for the assessment: * Indeterminate or Unhealed * Poor * Fair * Good * Excellent

次要结局

未报告次要终点

研究者

发起方
University of Santo Tomas Hospital, Philippines
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fiona Bianca V. Enriquez

Principal Investigator

University of Santo Tomas Hospital, Philippines

研究点 (1)

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