A Within-Scar, Randomized Control Trial Comparing Fractional Ablative Carbon Dioxide Laser to Non-Energy-Based, Mechanical Tissue Extraction and No Treatment
Abstract
Objectives and Rationale: Survivors of burn injuries face many challenges in their recovery. One of those challenges they commonly face is the result of scarring from their injury. These particular scars can be quite debilitating as they can limit mobility of the skin, result in decreased movement to parts of the body, and also be associated with pain and itching. While there are non-surgical treatments for these scars, they can be very expensive, time-consuming and uncomfortable for patients, and have limited improvements. Surgical treatments for the scarring exist, but they have their own downsides including pain, risk of complications, and longer recovery. The introduction of fractional ablative carbon dioxide (CO2) lasers has offered tremendous potential to help improve scars, with minimal pain, downtime, and cost compared to the traditional approaches. Despite the promising studies, we do not have clear data demonstrating whether the laser works, how it works, or, more importantly, how laser treatment changes people s quality of life or long-term outcomes. This study is designed to begin to address these gaps in our current knowledge. Applicability and Impact: This study addresses the needs outlined in the Military Burn Research Program by conducting a clinical study with the potential to have a major impact on the treatment of debilitating burn scars to military personnel. It will also help to improve function outcomes for burn survivors by assessing the efficacy of this treatment as well as through the use of patient-reported outcomes. This study will benefit Service members and/or Veterans that sustained traumatic burn injuries as well as civilian burn survivors with thickened, abnormal, symptomatic scarring known as hypertrophic burn scars. It evaluates whether the CO2 laser improves burn scars compared to no treatment. It also evaluates whether the burn created by the laser to remove tissue is beneficial by comparing the laser to an additional group that removes a comparable amount of tissue using punch biopsies. The benefit of this clinical trial is that it has the potential to provide a clear answer as to whether and how the CO2 laser works to treat burn scars. With a well-designed study, patients could more easily obtain access to the treatment both through increased awareness of their providers and through quality data that insurance companies could reference to support coverage. It would also allow us to look both within the scar on the cellular and genetic level as well as on a larger patient outcome scale to better understand how the treatment impacts a patient s recovery from burn injury. We will also try to understand how laser and other reconstructive treatments impact patients lives through administration of specialized surveys known as patient-reported outcome metrics (PROMs). These surveys help us better understand how their burn injuries impact their lives in ways beyond physical scars so we can better help patients recover and reintegrate into their lives. While there are small risks to laser treatment, related to the need for anesthesia, these wound healing/scarring complication risks are small, especially when compared to traditional surgical treatments. We anticipate the study would take 3 years to complete and within 4 years we would be able to start reporting the data from the findings of the study to the public. Benefit to Service Members: Service members that sustain burn injuries want to achieve the best possible recovery and reintegration into their lives. Regardless whether the goal is to return to active duty or reintegrate into a life outside of military service, this study offers the potential to help. Treatments that lead to improvement of scars more quickly than traditional therapy could in turn lead to more efficient treatment of hypertrophic burn scars and earlier return to active duty. Understanding what happens on a cellular and genetic level may lead to new treatments a
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Oct 29, 2018
- Source ID
- W81XWH1810608
Entities
People
- Jonathan Friedstat
Organizations
- Massachusetts General Hospital
- United States Army