The Effects of Timolol On Healing and Cosmesis of Mohs Scalp Wounds: An Open Label Trial
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:
- Compare wound healing speed between patients treated with topical timolol and those receiving standard wound care only.
- Compare cosmetic outcomes using topical timolol and standard wound care.
- 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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Michael Woodfin, MD
- 電話番号：570-271-8050
- メール：mwwoodfin1@geisinger.edu
研究連絡先のバックアップ
- 名前：Amrit Greene, MD
- 電話番号：570-271-8050
- メール：agreene2@geisinger.edu
研究場所
-
-
Pennsylvania
-
Danville、Pennsylvania、アメリカ、17821
- Geisinger Dermatology Woodbine
-
コンタクト：
- Michael Woodfin, MD
- 電話番号：570-271-8050
- メール：mwwoodfin1@geisinger.edu
-
コンタクト：
- Amrit Greene, MD
- 電話番号：570-271-8050
- メール：agreene2@geisinger.edu
-
主任研究者：
- Amrit Greene, MD
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Timolol Arm
This arm will have their wounds treated with topical timolol.
|
Topical timolol is the active drug that will be compared to placebo in the trial.
|
|
プラセボコンパレーター：Standard of Care Arm
This arm will have their wounds treated with normal saline/standard of care.
|
Normal saline is the placebo that will be compared to topical timolol in the trial.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Healing At 12 Weeks
時間枠：From treatment start to follow up 12 weeks later
|
Percentage of patients achieving complete re-epithelialization at 12 weeks
|
From treatment start to follow up 12 weeks later
|
|
Scar Cosmesis
時間枠：Calculated at 4, 8, and 12 week follow up after treatment start.
|
Scar cosmesis calculated using visual analog scale (VAS)
|
Calculated at 4, 8, and 12 week follow up after treatment start.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Healing At 8 Weeks
時間枠：From treatment start to follow up 8 weeks later
|
Percentage of patients achieving complete re-epithelialization at 8 weeks
|
From treatment start to follow up 8 weeks later
|
|
Healing At 4 Weeks
時間枠：From treatment start to follow up 4 weeks later
|
Percentage of patients achieving complete re-epithelialization at 4 weeks
|
From treatment start to follow up 4 weeks later
|
|
Change In Wound Area at Follow Up
時間枠：Calculated at 4, 8, and 12 week follow up after treatment start.
|
Percentage change in overall wound area at specified follow up windows.
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Calculated at 4, 8, and 12 week follow up after treatment start.
|
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Calls for Non-healing Wounds
時間枠：From treatment start to 12 weeks.
|
The number of calls made to our clinic for non-healing wounds or other wound related concerns.
|
From treatment start to 12 weeks.
|
|
Visits for Non-healing Wounds
時間枠：From treatment start to 12 weeks.
|
The number of visits (other than planned follow up) made to our clinic for non-healing wounds or other wound related concerns.
|
From treatment start to 12 weeks.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Amrit Greene, MD、Geisinger Clinic
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- Effects of Timolol Mohs Scalp
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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