Effects of Pulsed Dye and CO2 Laser in Treatment of Hypertrophic Burn Scars.

NCT ID: NCT04769089

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-19
• Study Completion Date: 2020-06-24

Brief Summary

A prospective, double blind, randomized controlled human clinical trial will be conducted by enrolling patients referred for laser treatment from the USAISR burn clinic. Laser candidates will be asked to participate who have an area of extremity or truncal scar measuring approximately 6cmX6cm total, in one contiguous region. The study sites, will consist of four equally sized treatment areas (3cm x 3cm), will be randomized to be treated with PDL, CO2, a combination of CO2+PDL, and an untreated control for 6 treatments. The areas will be photographed prior to each treatment and at the final visit 4-6 months after the last treatment. Color, pliability and thickness will be measured using a colorimeter, cutometer and high frequency ultrasound respectively at each appointment. Additionally, the Patient Observer Scar Assessment Scale (POSAS) will be used to score the quality of the scar, using two trained, blinded observers. The patients will also be asked on a voluntary basis for a pre-trial and post-trial 3mm punch biopsy to evaluate for the presence of histological changes.

Conditions

Hypertrophic Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pulse Dye Laser

Treatment with PDL alone.

Group Type: EXPERIMENTAL

Treatment with Pulse Dye Laser

Intervention Type: PROCEDURE

Pulse Dye laser treatment will be applied to one randomized area with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s.

CO2 Laser

Treatment with CO2 alone.

Group Type: EXPERIMENTAL

Treatment with CO2 Laser

Intervention Type: PROCEDURE

CO2 laser treatment will be applied to one randomized area with the deep Fx hand piece, 300Hz, 15mJ, 15% density.

Combination

Treatment with both PDL and CO2 laser.

Group Type: EXPERIMENTAL

Treatment with combination of pulse dye laser and CO2 laser.

Intervention Type: PROCEDURE

Pulse Dye laser and CO2 treatment will be applied to one randomized area. Pulse Dye will be applied with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s followed by the CO2 laser treatment with the deep Fx hand piece, 300Hz, 15mJ, 15% density.

No treatment

No laser treatment.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

One area will be randomized to receive no laser treatment.

Interventions

Treatment with Pulse Dye Laser

Pulse Dye laser treatment will be applied to one randomized area with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s.

Intervention Type: PROCEDURE

Treatment with CO2 Laser

CO2 laser treatment will be applied to one randomized area with the deep Fx hand piece, 300Hz, 15mJ, 15% density.

Intervention Type: PROCEDURE

Treatment with combination of pulse dye laser and CO2 laser.

Pulse Dye laser and CO2 treatment will be applied to one randomized area. Pulse Dye will be applied with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s followed by the CO2 laser treatment with the deep Fx hand piece, 300Hz, 15mJ, 15% density.

Intervention Type: PROCEDURE

Control

One area will be randomized to receive no laser treatment.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Must have at least four areas of burn scar located on the trunk or extremities measuring 3cm x 3cm and not previously treated with laser.

2. Timing: There has been a minimum of 1 month after burn closure

3. The subject is at least 18 years of age and not older than 65.

4. Able and willing to provide verbal and written consent.

Exclusion Criteria

1. Active infection in experimental area

2. Use of isotretinoin (Accutane) in last six months

3. Life or limb-threatening injury/disease

4. Prior history of non-compliance with medical regimes

5. Active drug use/abuse

6. Active psychiatric illness except depression (unless being treated for suicidal intentions)

7. Pregnancy

8. Active cancer, or new diagnosis of cancer within the past 5 years, with the exception of basal cell carcinoma, melanoma and squamous cell carcinoma, as long as the subject is disease free at the time of enrollment.

9. Prior PDL or other laser treatment of the study area.

10. Patient unable to tolerate laser procedure.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Army Institute of Surgical Research

FED

Sponsor Role: collaborator

The Metis Foundation

OTHER

Sponsor Role: lead

Responsible Party

Rodney Chan

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodney Chan, MD

Role: PRINCIPAL_INVESTIGATOR

Metis Foundation

Locations

United States Army Institute of Surgical Research

Fort Sam Houston, Texas, United States

Countries

United States

References

Cooper LE, Nuutila K, Kemp Bohan PM, Diaz V, Batchinsky M, Carlsson AH, Cancio LC, Chan RK. Analysis of the Utility of CO2 and Pulse-Dye Lasers Together and Separately in the Treatment of Hypertrophic Burn Scars. Ann Plast Surg. 2022 Aug 1;89(2):166-172. doi: 10.1097/SAP.0000000000003240.

Reference Type: DERIVED

PMID: 35943226 (View on PubMed)

Other Identifiers

M-10590

Identifier Type: -

Identifier Source: org_study_id