Fractionated Carbon Dioxide Laser and Burn Scar Contractures: Evaluation of Post-Treatment Scar Function and Appearance

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02115646

Enrollment

Registered

2014-04-16

Start date

2011-12-31

Completion date

2017-01-31

Last updated

2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Scars

Keywords

burn, scar

Brief summary

The investigators are studying the appearance and function of burn scars after treatment with fractionated carbon dioxide laser. The investigators hypothesize that the cosmetic appearance and range of motion will improve with treatment.

Detailed description

The primary goal of the study will analyze whether the fractionated carbon dioxide laser can improve other subjective and objective qualities of hypertrophic and/or contracted burn scars with or without involvement of nearby mobile joints. The investigators hypothesize that fractionated carbon dioxide laser therapy will increase range of motion and improve tissue compliance in all scars overlying a mobile joint that has been limited due to burn scar contracture. In addition, the investigators will evaluate the effect of fractionated carbon dioxide laser therapy on common sequelae of hypertrophic and/or contracted burn scars.

Interventions

DEVICEfractionated carbon dioxide laser

patients will have serial laser treatments

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Healthy males and females between 5 and 70 years of age with hypertrophic and/or contracted burn scars with or without involvement of mobile joints. The burn scars must have occurred at least 1 year prior to the date of enrollment. * Having suitable areas of treatment: All wounds in the area of interest must be closed for at least two months, and the scars must be deemed stable for a period of 3 months before initiation of treatment. * Fitzpatrick skin types I-VI * Able and willing to comply with all visit, treatment and evaluation schedules and requirements * Able to understand provide written informed consent * Women of child-bearing age are required to be using a reliable method of birth control at least three months prior to study enrollment and throughout the course of the study.

Exclusion criteria

* Pregnant, intending to become pregnant during the course of the study, less than three months postpartum or less than six weeks after completion of breastfeeding. * Active tanning, including the use of tanning booths, during the course of the study * Showing symptoms of hormonal disorders (i.e.: uncontrolled thyroid disease or Polycystic Ovary Syndrome), as per the Investigator's discretion * Abnormal photosensitivity due to metabolic disorder or due to use of external agents, (drugs, herbs, etc.) within 2 weeks of initial treatment or during the course of the study, except for use of aminolevulinic acid(Levulan®) which requires a washout period of three months * Prior use of retinoids in treated areas within three months of initial treatment or during the course of the study * Use of oral isotretinoin (Accutane®) within nine months of initial treatment or during the course of the study. Note: skin must retain its normal degree of moisture prior to treatment * Prior skin treatment with laser or other devices in the treated area within three months of initial treatment or during the course of the study * Adverse reactions to compounds of any external agent (e.g., gels, lotions or anesthetic creams) required for use in the study, if no alternative to the said agent exists * History of collagen vascular disease * Concurrent inflammatory skin conditions, including, but not limited to, rosacea of any severity * Active Herpes Simplex at the time of treatment or having experienced more than three episodes of Herpes Simplex eruption within a year of study enrollment * Multiple dysplastic nevi in area to be treated * Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to each treatment (as per the patient's physician discretion) * History of immunosuppression/immune deficiency disorders (including human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) or use of immunosuppressive medications * Having any form of active cancer at the time of enrollment and during the course of the study * Significant concurrent illness, such as uncontrolled diabetes, (i.e., any disease state that in the opinion of the Investigator would interfere with the anesthesia, treatment, or healing process) * Mentally incompetent, prisoner or evidence of active substance or alcohol abuse * Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or study personnel) to treat the subject as part of this research study * If it is determined that the contracture is due to a deeper process involving the muscles, ligaments or bones.

Design outcomes

Primary

Measure	Time frame	Description
Scar Pigmentation, Baseline vs 15-months	Baseline and 15 months	Using the colorimeter, will measure change in pigmentation of the scar at the conclusion of the study. This tool measures the pigment in a scar, with a possible range of 0-100, with 100 being the darkest hyperpigmentation, and 0 being no hyperpigmentation.
Scar Elasticity, Baseline vs 15-months	Baseline and 15 months	This is the measure of the elasticity of the scar using a Torque-meter. It is measured on a 0-1 unit scale, with 0 being normal skin elasticity and 1 being completely inelastic.
Scar Thickness	Baseline and 15 months	This is an ultrasound measurement using the Dermascan Cyberderm to measure the thickness of the scar at baseline in millimeters.

Secondary

Measure	Time frame	Description
Quality of Life	Baseline and 15 months	The 36-Item Short Form Survey (SF-36) is a validated quality of life measurement tool. It measures 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. It is scored on a 0-100 scale, with 100 being the least bothersome to quality of life.
POSAS	Baseline and 15 months	The Patient and Observer Scar Assessment Scale (POSAS) is a validated scale that measures both the patient assessment and the observer assessment on the quality (height, color, stiffness, thickness, symptoms, relief, surface area) of the scar. Scores range from 0-60, with 60 being the worst quality of scar.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Fractionated CO2 Laser Treatment Fractionated carbon dioxide laser Fractionated carbon dioxide laser: patients received serial fractionated CO2 laser treatments for a total fo 3 treatments.	22
Total	22

Baseline characteristics

Characteristic	Fractionated CO2 Laser Treatment
Age, Categorical <=18 years	11 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	11 Participants
Age, Continuous	28 years STANDARD_DEVIATION 16.8
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants
POSAS	27.2 units on a scale STANDARD_DEVIATION 1.8
Quality of Life	91.25 units on a scale STANDARD_DEVIATION 8.56
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	20 Participants
Region of Enrollment United States	22 Participants
Scar elasticity	0.65 units on a scale STANDARD_DEVIATION 0.12
Scar pigmentation	50.93 units on a scale
Scar thickness	3.28 mm STANDARD_DEVIATION 1.21
Sex: Female, Male Female	7 Participants
Sex: Female, Male Male	15 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 22
other Total, other adverse events	0 / 22
serious Total, serious adverse events	0 / 22

Outcome results

Primary

Scar Elasticity, Baseline vs 15-months

This is the measure of the elasticity of the scar using a Torque-meter. It is measured on a 0-1 unit scale, with 0 being normal skin elasticity and 1 being completely inelastic.