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
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
- 否
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
Skin punch biopsy wound treated with hydrocolloid dressing.
干预措施: Hydrocolloid Dressing (DuoDERM CGF) (Drug)
Topical Antibiotic
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
Fiona Bianca V. Enriquez
Principal Investigator
University of Santo Tomas Hospital, Philippines
