Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to evaluate the efficacy and safety of topical timolol 0.5% for secondary intention wound healing following 1) Mohs micrographic surgery, 2) standard surgical excision, OR 3) electrodesiccation and curettage (ED&C). Please note that healing by secondary intention refers to when a wound heals naturally without surgical closure.
To evaluate the efficacy of topical timolol 0.5%, 220 participants will be recruited. Participants will be placed into one of two groups: The treatment group or the control group.
During this 12-week period, both groups will be required to upload photos of their wound healing to their MyChart account at weeks 3, 6, 9, and 12. These photos will be reviewed by the investigator to assess wound healing. Re-epithelialization and earlier complete wound healing will be compared between both groups to determine the efficacy of topical timolol 0.5% solution compared to the standard of care.
Secondary intention healing after cutaneous excisions or Mohs surgery is a commonly utilized technique in areas that are under high tension, in which primary closure would not be effective, or when patients defer a more complex closure technique. Secondary intention healing has drawbacks, as they take longer to heal and patients are left with a large wound at the surgical site for approximately 8 weeks. Topical timolol has shown promising results in lower extremity ulcers to improve wound healing, however larger trials on secondary intention surgical wounds have not been studied. This trial aims to fill this gap by comparing the efficacy and safety of topical timolol to standard wound care over a 12-week interval.
Participants who agree to the study, and who have opted to heal by secondary intention healing following their 1) Mohs micrographic surgery, 2) standard surgical excision, OR 3) electrodesiccation and curettage (ED&C) will be consented.
Once consented, the participant's demographics, medical history, and surgery details will be collected before being randomized into one of two groups: the treatment group or the control group.
The participants and the research team will be blinded, meaning that they will not know which treatment the participant receives. Participants in both groups will be asked to upload photos of their wound healing at weeks 3, 6, 9, and 12 for the research team to examine.
The data will be analyzed to determine which group experienced faster re-epithelialization and earlier complete wound healing.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Timolol | Experimental | The treatment group will receive a topical timolol 0.5% solution, which will be applied to their wound daily for 12 weeks. |
|
| Hydrogel | Placebo Comparator | The control group will receive standard care with the addition of hydrogel, which will also be applied to their wound daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timolol 0.5% Ophthalmic Solution | Drug | Topical Timolol 0.5% solution will be applied to patients wounds in 2 cm intervals along the widest diameter of the wound daily for 12 weeks following their medical procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Area of Surgical Ulcer | The percent change in the area of surgical ulcers in patients using the study medication (treatment group) will be compared to those receiving standard care (placebo group). | Baseline, week 3, week 6, week 9 and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Infection Rate | The number of patients who develop infections during treatment in both the treatment and placebo groups. | Baseline to Week 12 |
| Risk Factor for Poor Wound Healing | Sub-group analysis in patients with risk factors for poor wound healing; diabetes, smoking, cardiovascular disease, peripheral vascular disease, venous insufficiency, and/or long term prednisone use. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Eisen, MD | Contact | (916)-551-2611 | dbeisen@health.ucdavis.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center- Sacramento | Sacramento | California | 95655 | United States |
Not provided
| ID | Term |
|---|---|
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D013999 | Timolol |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hydrogel of placebo | Other | Hydrogel will be placed on the wound at 2 cm intervals along the widest diameter of the wound daily for 12 weeks following the patient's medical procedure. |
|
| Baseline to Week 12 |
| Type of Wounds | Subgroup analyses will be performed by wound type (Mohs surgery, excision, ED&C) to assess for differential treatment effects. | Baseline to Week 12 |
| Incidences of Hypotension | Incidence of clinically significant hypotension (requiring medical attention) in patients treated with timolol | Baseline to Week 12 |
| Incidences of COPD or Asthma Exacerbations | Incidence of Chronic Obstructive Pulmonary Disease (COPD) or Asthma exacerbations in patients treated with timolol vs control. | Baseline to Week 12 |
| Incidences of Hypertrophic Scar or Keloid | The number of patients developing hypertrophic scar or keloid. | Baseline to Week 12 |
| Incidences of Post Operative Bleeding | The number of patients who developed post operative bleeding, and those who needed intervention by our clinic. | Baseline to Week 12 |
| Use of Antibiotic | The number of patients who started a topical or oral antibiotic during study treatment. | Baseline to Week 12 |
| UC Davis Health- Dermatology | Sacramento | California | 95816 | United States |
|
| 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 |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |