Not provided
Not provided
Not provided
Not provided
Not provided
device not available to initiate study.
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 learn about the effects of the 2940 nm Erbium: Yttrium-Aluminum-Garnet (Er:YAG) laser on treating surgical scar using optical coherence tomography, a medical imaging device.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Er:YAG laser Group | Experimental | The study is a split-scar model. Participants will have half of their lesion receive a total of three sessions using 2940 nm Er:YAG laser spaced over a 4-week study participation interval. |
|
| Control (No Intervention) Group | No Intervention | The study is a split-scar model. Participants will serve as their own control and have half of their lesion receive no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Er:YAG laser | Device | 2940 nm Er:YAG laser treatment spread over 3 sessions within 4 weeks on participant's scar on either the head/neck, trunk or extremities. |
|
| Measure | Description | Time Frame |
|---|---|---|
| POSAS Scar Assessment | Patient and Observer Scar Assessment Scale (POSAS) has a total score ranging from 6 (normal skin) to 60 (severely scarred skin). | Up to 13 weeks |
| Surgical Scar Blood Flow | As measured using optical coherence tomography | Up to 13 weeks |
| Surgical Scar Skin Roughness | As measured using optical coherence tomography | Up to 13 weeks |
| Surgical Scar Collagen Content | As measured using optical coherence tomography | Up to 13 weeks |
| Surgical Scar Epidermal Thickness | As measured using optical coherence tomography | Up to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Adverse events reported by participant and evaluated by treating physician | Up to 13 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Keyvan Nouri, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided