Laser treated Group for Epidermal Thickening

N/A

Waitlist Available

Led By Charles N. Cornell, MD

Research Sponsored by Charles Cornell, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 week, 8 week, 3 month, and 1 year follow up visits

Awards & highlights

Study Summary

The condition to be studied is post-surgical scarring following primary total knee replacement, specifically whether fractional non-ablative laser therapy can be used to significantly decrease the morbidity of scarring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 week, 8 week, 3 month, and 1 year follow up visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 week, 8 week, 3 month, and 1 year follow up visits

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 week, 8 week, 3 month, and 1 year follow up visits for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The change in POSAS scores between patients in the laser treated group and the not laser treated group at 4 weeks, 8 weeks, 3 month, and 1 year follow up visits.

Secondary outcome measures

KOOS

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Laser treated GroupExperimental Treatment1 Intervention

Patients in this group will be given the laser treatment with the non-abilative 1540 nm wavelength. Patients will be blinded to this procedure as they will be wearing protective eye wear and noise canceling headphones. These patients will undergo the treatment 3 times, one at day of discharge, second at the 4 week follow up visit, and third at the 8 week follow up visit. After the 8 week follow up visit, patients will be asked to come in for the 3 month follow up visit and 1 year follow up visit for an evaluation. At each visit, the patient's scar will be photograph for evaluation. Each patient will also be asked to fill out the POSAS, and KOOS at each follow up visits. Thus, patients in this group will be getting the Non-Abilative laser treatment.

Group II: Not Laser treated GroupPlacebo Group1 Intervention

Patients in this group will be given the laser treatment with the 1540 non-abilative laser device, but the device will not be set to provide treatment. Patients will be blinded to this procedure as they will be wearing protective eye wear and noise canceling headphones. These patients will undergo the treatment 3 times, one at day of discharge, second at the 4 week follow up visit, and third at the 8 week follow up visit. After the 8 week follow up visit, patients will be asked to come in for the 3 month follow up visit and 1 year follow up visit for an evaluation. At each visit, the patient's scar will be photograph for evaluation. Each patient will also be asked to fill out the POSAS, and KOOS at each follow up visits.

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