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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Michael Woodfin, MD
- 전화번호: 570-271-8050
- 이메일: mwwoodfin1@geisinger.edu
연구 연락처 백업
- 이름: Amrit Greene, MD
- 전화번호: 570-271-8050
- 이메일: agreene2@geisinger.edu
연구 장소
-
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Pennsylvania
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Danville, Pennsylvania, 미국, 17821
- Geisinger Dermatology Woodbine
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연락하다:
- Michael Woodfin, MD
- 전화번호: 570-271-8050
- 이메일: mwwoodfin1@geisinger.edu
-
연락하다:
- Amrit Greene, MD
- 전화번호: 570-271-8050
- 이메일: agreene2@geisinger.edu
-
수석 연구원:
- Amrit Greene, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Timolol Arm
This arm will have their wounds treated with topical timolol.
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Topical timolol is the active drug that will be compared to placebo in the trial.
|
|
위약 비교기: Standard of Care Arm
This arm will have their wounds treated with normal saline/standard of care.
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Normal saline is the placebo that will be compared to topical timolol in the trial.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Healing At 12 Weeks
기간: From treatment start to follow up 12 weeks later
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Percentage of patients achieving complete re-epithelialization at 12 weeks
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From treatment start to follow up 12 weeks later
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Scar Cosmesis
기간: Calculated at 4, 8, and 12 week follow up after treatment start.
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Scar cosmesis calculated using visual analog scale (VAS)
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Calculated at 4, 8, and 12 week follow up after treatment start.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Healing At 8 Weeks
기간: From treatment start to follow up 8 weeks later
|
Percentage of patients achieving complete re-epithelialization at 8 weeks
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From treatment start to follow up 8 weeks later
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Healing At 4 Weeks
기간: From treatment start to follow up 4 weeks later
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Percentage of patients achieving complete re-epithelialization at 4 weeks
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From treatment start to follow up 4 weeks later
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Change In Wound Area at Follow Up
기간: Calculated at 4, 8, and 12 week follow up after treatment start.
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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
기간: From treatment start to 12 weeks.
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The number of calls made to our clinic for non-healing wounds or other wound related concerns.
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From treatment start to 12 weeks.
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Visits for Non-healing Wounds
기간: From treatment start to 12 weeks.
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The number of visits (other than planned follow up) made to our clinic for non-healing wounds or other wound related concerns.
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From treatment start to 12 weeks.
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Amrit Greene, MD, Geisinger Clinic
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Effects of Timolol Mohs Scalp
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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