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Набор скоро начнётся NCT07583862

The Effects of Timolol On Healing and Cosmesis of Mohs Scalp Wounds: An Open Label Trial

Фаза II С лечением Surgical Wounds Mohs Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Topical Timolol, Normal Saline.
Кому может быть актуально
Состояния в реестре: Surgical Wounds, Mohs Surgery. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The goal of this study clinical trial is to learn if topical timolol can accelerate healing and improve the cosmetic appearance of surgical wounds on the scalp following Mohs surgery. It will include Geisinger patients 18 year or older who undergo Mohs surgery of the scalp with planned wound healing by secondary intent. The main questions in aim to answer are: 1. Compare wound healing speed between patients treated with topical timolol and those receiving standard wound care only. 2. Compare cosmetic outcomes using topical timolol and standard wound care. 3. Evaluate the impact of topical timolol on the number of unplanned follow-up visits and calls related to delayed wound healing. Participants will be asked use either topical timolol or use standard wound care to treat their Mohs surgery scalp wound. They will follow-up around 4, 8 and 12 weeks.

Подробное описание

Mohs surgical wounds of the scalp and anterior lower leg share several characteristics. They both involve convex surfaces with high tissue tension, and both are often allowed to heal by secondary intent. Secondary intent healing on the scalp is a slow process, with studies noting a mean time for re-epithelialization ranging from 7 to 26 weeks, depending on if the periosteum is intact.

Recently, topical timolol has garnered attention for its effectiveness in promoting healing of open wounds on the lower extremity. Studies have shown improved healing in patients with comorbidities, an impressive safety profile, and improved cosmesis in wounds healing by secondary intent.5 To our knowledge, no study to date has sought to evaluate the effect of topical timolol on surgical wounds of the scalp.

The study population will be patients at our institution who have undergone Mohs surgery and for whom secondary intent healing ("granulation") is deemed an appropriate treatment.

Endpoints will include time to re-epithelialization, percentage change in wound area, and cosmesis (measured using VAS) at pre-determined follow up intervals.

The potential contribution of this research is to provide evidence on the efficacy and safety of topical timolol in accelerating healing and improving the cosmetic appearance of surgical wounds on the scalp.

We anticipate that timolol will speed wound healing and improve cosmesis of scalp wounds, just as it has in other surgical and non-surgical granulating wounds. The benefits of faster healing and improved cosmesis to individual patients are obvious.

This study may also positively impact health care providers and the health care system, as we anticipate those with faster healing wounds will need fewer follow-up visits and make fewer calls for non-healing wounds.

The affordability of topical timolol could make effective wound care more accessible to a broader range of patients, potentially reducing overall healthcare costs associated with prolonged wound healing and complications. In the future, timolol may be used instead of expensive surgical procedures, allografts, xenografts, and other expensive grafting materials. This cost reduction is also anticipated to benefit health systems.

We anticipate that other institutions will adopt the use of topical timolol for Mohs wounds of the scalp, and that eventually this may become the new standard of care.

Вмешательства

  • Препарат Topical Timolol
    Topical timolol is the active drug that will be compared to placebo in the trial.
  • Препарат Normal Saline
    Normal saline is the placebo that will be compared to topical timolol in the trial.

Первичные конечные точки

  • Healing At 12 Weeks [Срок оценки: From treatment start to follow up 12 weeks later]
  • Scar Cosmesis [Срок оценки: Calculated at 4, 8, and 12 week follow up after treatment start.]
Вторичные конечные точки (5)
  • Healing At 8 Weeks [Срок оценки: From treatment start to follow up 8 weeks later]
  • Healing At 4 Weeks [Срок оценки: From treatment start to follow up 4 weeks later]
  • Change In Wound Area at Follow Up [Срок оценки: Calculated at 4, 8, and 12 week follow up after treatment start.]
  • Calls for Non-healing Wounds [Срок оценки: From treatment start to 12 weeks.]
  • Visits for Non-healing Wounds [Срок оценки: From treatment start to 12 weeks.]

Критерии участия

Критерии включения

Age: Adults aged 18 years and older. Condition: Patients who have undergone Mohs surgery on the scalp. Consent: Ability to provide informed consent. Willingness to Participate: Willingness to comply with study procedures and attend follow-up visits.

Healing by Secondary Intention: Wounds intended to heal by secondary intention.

Критерии исключения

  • Known allergy or sensitivity to timolol or any components of the study medication.
  • Bronchial asthma or history of bronchial asthma
  • Severe chronic obstructive pulmonary disease (COPD)
  • Sinus bradycardia
  • Second or third-degree atrioventricular block
  • Overt heart failure
  • Cardiogenic shock
  • Under the influence of opioids or benzodiazepines at time of enrollment
  • History of scarring alopecia in area of Mohs wound
  • History of radiation treatment
  • Patients being treated for recurrent tumors

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Geisinger Dermatology Woodbine — Danville

Идентификаторы

NCT: NCT07583862 · Effects of Timolol Mohs Scalp

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗