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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Timolol Arm | Active Comparator | This arm will have their wounds treated with topical timolol. |
|
| Standard of Care Arm | Placebo Comparator | This arm will have their wounds treated with normal saline/standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Timolol | Drug | Topical timolol is the active drug that will be compared to placebo in the trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healing At 12 Weeks | Percentage of patients achieving complete re-epithelialization at 12 weeks | From treatment start to follow up 12 weeks later |
| Scar Cosmesis | Scar cosmesis calculated using visual analog scale (VAS) | Calculated at 4, 8, and 12 week follow up after treatment start. |
| Measure | Description | Time Frame |
|---|---|---|
| Healing At 8 Weeks | Percentage of patients achieving complete re-epithelialization at 8 weeks | From treatment start to follow up 8 weeks later |
| Healing At 4 Weeks | Percentage of patients achieving complete re-epithelialization at 4 weeks |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Woodfin, MD | Contact | 570-271-8050 | mwwoodfin1@geisinger.edu | |
| Amrit Greene, MD | Contact | 570-271-8050 | agreene2@geisinger.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amrit Greene, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Dermatology Woodbine | Danville | Pennsylvania | 17821 | United States |
Although we feel that re-identification of anonymized participants using IPD would be very low risk, we prefer to not add any additional risk of patient identification. Furthermore, funding for this study is limited, and preparing data for sharing, including anonymizing it and creating documentation may not be possible due to budget and time constraints.
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013999 | Timolol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Normal Saline | Drug | Normal saline is the placebo that will be compared to topical timolol in the trial. |
|
| From treatment start to follow up 4 weeks later |
| Change In Wound Area at Follow Up | Percentage change in overall wound area at specified follow up windows. | Calculated at 4, 8, and 12 week follow up after treatment start. |
| Calls for Non-healing Wounds | 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 | 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. |
| D020005 |
| Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |