Treatment of Post-Surgical Scars With Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG

NCT02397564 | Completed Results DMC

• 1 other identifier: 14.1075
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators will compare the efficacy of Traditional Ablative Er:YAG Versus Fractional Ablative Er:YAG in a split scar study. The patient will receive a month treatment for 3 months. Then follow up for the next 2 months.

Conditions

Post-Surgical Scars

Keywords

scar; ICD-10 CM:L90.5

Outcome Measures

Primary Outcomes (1)

• Patient Observer Scar Assessment Scale (POSAS)

  It uses a 10-point scoring system with a score of 1 representing a normal-appearing skin and a score of 10 representing the worst possible scar. Total scores range from 6 to 60 with the lower score indicate a better outcome.

  5 months

Secondary Outcomes (1)

• Patient Preference

  5 months

Study Arms (1)

1

EXPERIMENTAL

Enroll 20 patients for nonsurgical treatment of surgical scars. Half of each scar will be treated with the Er:YAG laser on the traditional ablative setting and the other half of the scar will receive Er:YAG treatment with the fractional ablative setting. The patients will receive 3 treatments at monthly intervals. They will follow up at 1 and 2 months after the treatment.

Device: Er:YAG laser, traditional and fractional settings

Interventions

Er:YAG laser, traditional and fractional settings DEVICE

Half the scar will be treated with traditional ablative setting and the other half will be treated with the fractional ablative setting

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 8 weeks s/p scar
• linear closure
• visibly symmetric scar
• over 18 years old

You may not qualify if:

• concomitant treatment of involved skin
• propensity for keloid scarring
• use of oral retinoids for the past 1 year
• pregnancy
• immunosuppression
• prior laser to the area

Sponsors & Collaborators

• University of Louisville: lead

MeSH Terms

Conditions

Cicatrix

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: W. James Tidwell
• Organization: University of Louisville

wjamestidwell@gmail.com

5025831749

Study Officials

• Timothy S Brown, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 25, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 1, 2017
• Results First Posted: July 2, 2017

Record last verified: 2017-07