Efficacy of Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Wound surface area healing (skin reepithelialization)
研究概览
简要总结
Topical timolol, a β2-Adrenergic receptor (B2AR) antagonist, has demonstrated promise in wound healing over the past several years. The majority of the literature has evaluated the use of topical timolol to shorten wound healing time in chronic wounds of non-surgical etiologies. To date, there are no prospective randomized clinical trials evaluating the role of topical timolol for shortening wound healing time in acute open surgical wounds.
Therefore, the purpose of this study is to determine whether or not topical timolol solution decreases time to wound healing in patients with defects after Mohs Micrographic Surgery (MMS) that cannot be closed with sutures and are left to heal by second intent. The research team also will look to determine if there is a difference in cosmesis of wounds treated with topical timolol compared to those treated with the standard of care. The present study will primarily focus on wounds in the distal lower extremity as these are most commonly left to heal by secondary intent
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Be scheduled to undergo MMS at 234 East 85th St for a skin cancer that is deemed Mohs
- •Appropriate by the Mohs surgery appropriate use criteria
- •Have an open surgical wound < 4 cm and > 0.5 cm
- •Be ≥18 years of age
- •English-speaking
- •Provide a signed and dated informed consent form
- •State willingness to comply with all study procedures
排除标准
- •Age less than 18 years of age
- •Open surgical wound > 4 cm
- •If tumor clearance cannot be achieved with MMS
- •Pregnant women
- •Breastfeeding women
- •Patients who are taking oral beta-blockers (ie oral timolol, metoprolol, carvedilol, propranolol, atenolol)
- •Patients who are currently taking any of the following medications: clonidine, digoxin, methyldopa, quinidine, fluoxetine and paroxetine, bupropion
- •Patient currently taking a calcium channel blocker AND has pre-existing heart failure as defined by a reduced ejection fraction
- •Patients with pre-existing hypotension
- •Pre-existing diagnosis of sinus bradycardia
- •Pre-existing diagnosis of second or third degree atrioventricular block
- •Congestive heart failure
- •Pre-existing diagnosis of severe asthma
- •Pre-existing diagnosis of chronic obstructive pulmonary disease
- •Any known hypersensitivity to 0.5% timolol solution
- •Patients who have a wound where primary closure is feasible and desired by the patient
- •Defect size <0.5 cm
- •Prior sensitivity or known allergy to timolol
研究组 & 干预措施
Timolol
Participants in the topical timolol group will be instructed to apply 1-3 drops of topical 0.5% timolol solution daily to the wound.
干预措施: Timolol Maleate Solution (Drug)
Standard of Care
Standard of Care - Apply Vaseline and Band-Aid to wound bed daily
干预措施: Standard of Care (Other)
结局指标
主要结局
Wound surface area healing (skin reepithelialization)
时间窗: 2 weeks, 4 weeks, 6 weeks, 12 weeks
The wound surface area healing (skin reepithelialization) in open post-surgical lower extremity wounds will be measured using a ruler.
次要结局
- Percentage change in surgical wound size(2 weeks, 4 weeks, 6 weeks, 12 weeks)
- Modified Manchester Scar Scale (MMSS)(2 weeks, 4 weeks, 6 weeks, 12 weeks)
- The Pain, Enjoyment of Life and General Activity scale (PEG)(2 weeks, 4 weeks, 6 weeks, 12 weeks)
- Wound Quality of Life Questionnaire (Wound-QOL)(2 weeks, 4 weeks, 6 weeks, 12 weeks)
研究者
Jesse Lewin
Vice Chair of Surgical Operations, System Chief of the Division of Dermatologic & Cosmetic Surgery
Icahn School of Medicine at Mount Sinai