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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Timolol | Experimental | Participants in the topical timolol group will be instructed to apply 1-3 drops of topical 0.5% timolol solution daily to the wound. |
|
| Standard of Care | Active Comparator | Standard of Care - Apply Vaseline and Band-Aid to wound bed daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timolol Maleate Solution | Drug | Timolol 0.5% solution. The number of drops delivered will be based on the initial wound size and will remain constant for the duration of the study period or until the wound is fully re-epithelialized which will be determined by the PI either by photo or in person visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound surface area healing (skin reepithelialization) | The wound surface area healing (skin reepithelialization) in open post-surgical lower extremity wounds will be measured using a ruler. | 2 weeks, 4 weeks, 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in surgical wound size | Percentage change in surgical wound size | 2 weeks, 4 weeks, 6 weeks, 12 weeks |
| Modified Manchester Scar Scale (MMSS) | The Modified Manchester Scar Scale (MMSS) is a clinical tool used to evaluate the appearance and characteristics of scars. The MMSS assess four key aspects of the scar:
The total score ranges from 4 to 13, with higher scores indicating a more noticeable or problematic scar. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jesse Lewin, MD | Contact | 212-731-3316 | jesse.lewin@mountsinai.org | |
| Jaclyn Himeles, MD | Contact | 212-731-3316 | jaclyn.himeles@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Jesse Lewin, MD | Primary Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai | Recruiting | New York | New York | 10028 | United States |
All of the individual participant data collected during the trial, after deidentification.
Beginning 3 months and ending 5 years following article publication.
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.
To achieve aims in the approved proposal.
Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in ISMMS data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (to be determined).
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard of Care | Other | Vaseline |
|
| 2 weeks, 4 weeks, 6 weeks, 12 weeks |
| The Pain, Enjoyment of Life and General Activity scale (PEG) | The PEG, a Three-item Scale Assessing Pain Intensity and Interference Pain is is a 3-item questionnaire that measures pain intensity and pain-related functional interference with open wounds on the lower leg. The assessment includes three domains: average pain intensity (0-10), pain interference with enjoyment of life (0-10), and pain interference with general activity (0-10). The total score ranges from 0-30, with higher scores indicating greater pain intensity and greater pain-related functional interference. | 2 weeks, 4 weeks, 6 weeks, 12 weeks |
| Wound Quality of Life Questionnaire (Wound-QOL) | The Wound-QoL is a17-item questionnaire assesses how patients feel about their open wound its impact on their quality of life. The assessment evaluates multiple dimensions of wound-related quality of life, including physical symptoms (items 1-3), functional limitations (items 4, 11-15), psychological well-being (items 6-10), and burden of care (items 5, 16-17). Each item is scored on a 5-point scale from "Not at all" (0) to "Very much" (4). The total score ranges from 0-68, with higher scores indicating lower wound quality of life. | 2 weeks, 4 weeks, 6 weeks, 12 weeks |