Recruiting

Non-Ablative Fractional Resurfacing

Sponsor:

Charles Cornell, MD

Code:

NCT02166138

Conditions

Epidermal Thickening, Unspecified

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Non-Abilative Laser treatment

Study Details

Brief 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.

Conditions

Epidermal Thickening, Unspecified

Study ID

NCT02166138

Start date

Nov, 2013

Status verified date

Mar, 2015

Completion date

May, 2015

Anticipated

Primary completion date

May, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients will be included if:

  • They are indicated for primary total knee replacement
  • Have no history of wound healing problems, chronic infection, or known skin or connective tissue disease.
  • Are 18 years of age or older
  • Have a skin type classified as a Fitzpatrick type I-VI.

Exclusion Criteria:

  • Patients will be excluded for the following reasons:

  • Any prior history of surgery on their knee
  • Mental or psychological illness that prohibits the patient from completing the necessary forms

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Laser treated Group

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.

placebo comparator: Not Laser treated Group

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.

Interventions

Non-Abilative Laser treatment

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.

Primary outcome measure

  • 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. [ Time Frame: 4 week, 8 week, 3 month, and 1 year follow up visits ]

Central Contacts and Locations

Central contacts

Shivi Duggal, BS,MBA

2126061414duggals@hss.edu

Charles N. Cornell, MD

2126061414cornellc@hss.edu

Locations

Hospital for Special Surgery

Recruiting

NY, New York, United States, 10021

Contacts

Shivi Duggal, BS,MBA

212-606-1414duggals@hss.edu

Principal Investigator:

Charles N. Cornell, MD

More Information

Sponsor

Charles Cornell, MD

Last update posted

Mar 20, 2015

Last verified

Mar, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Charles Cornell, MD on 2015-03-20.