View clinical trials related to Hypertrophic Scar.
Filter by:A hypertrophic scar is a serious health concern in the industrialized world. Two groups of patients were treated with standard medical care. The experimental group received additional laser therapy. scar assessment was measured immediately before treatment, after 3, and 7 months. T test for comparison before-treatment between the control and study groups. ANOVA with repeated measures test for comparison among other measures.
To compare the effect of a class I pullulan based medical device containing Allium cepa & HA versus a class I medical device silicone gel on new post-surgical wounds
Phase 2a, prospective, randomized, double-blind, intra-subject, placebo-controlled, proof of concept study. Approximately twenty subjects will be randomized 1:1 to one of two treatment arms: Arm A: 2.0 mg/cm OLX10010 biweekly (every two weeks) Arm B: 5.0 mg/cm OLX10010 biweekly (every two weeks) Each treatment arm will have approximately 10 subjects. Each subject will receive both active (OLX10010) and control (placebo) treatment post-hypertrophic scar surgery biweekly (every two weeks) for a total of six doses. Dosing will occur post-surgery on Weeks 2, 4, 6, 8, 10, and 12. Post-treatment follow-up visits will occur at Weeks 18 and 24, and a long-term follow-up visit will occur at Month 12. The Patient and Observer Scar Assessment Scale (both physician and patient scales), Stony Brook Scar Evaluation Scale, Vancouver Scar Scale, and a photograph-based visual analog scale by blinded experts will be completed prior to scar revision surgery, at Weeks 2, 8, 12, 18, and 24, and at Month 12. The overall opinion responses on the physician scales of the POSAS at Week 24 will be used for primary endpoint analysis. The total length of the linear hypertrophic scar line will be divided equally for treatment with OLX10010 and placebo, injected intradermally per centimeter (cm). The OLX10010 end and placebo end of the scar line will be separated by a 2 cm or greater distance depending on the scar length. After the Week 24 visit, all data collected will be cleaned and all data management activities will be completed. After the database is frozen/locked, the primary endpoint efficacy analysis will be completed. If at least one of the treatment arms are shown to be appropriate to reduce recurrence of hypertrophic scars, all analyses will be performed. If the efficacy analysis of Arms A and B indicate the study doses are not as effective as expected, the sponsor may decide to add a third arm (Arm C) to explore the weekly dosing regimen. See detailed summary. Subjects in all study arms will continue in the study until their Month 12 visit. After all subjects complete that visit, data are collected, and data management activities are completed, Month 12 data will be analyzed.
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.
Burns can lead to lesions of total thickness, which extend the reticular layer of the dermis requiring a healing process, resulting in aesthetic problems, hypertrophic and functional scars that causes the patient a state of low esteem and social isolation. Elastic bandage - Kinesio tape - is a low cost therapeutic resource when compared to the compression mesh and silicone gel plates, commonly indicated for the conservative treatment of these scars. The compressive effect of the bandage on the hypertrophic scar tissue promotes the reduction of local vascularization and the realignment of the collagen fibers, resulting in the repair of the multidirectional mobility of the treated tissue. The aim of the study is to determine the effect of elastic bandage with tension on the inflammatory response of hypertrophic scars in patients with deep burns. It is a randomized, triple blind study. Patients aged 18-59 years with hypertrophic scars due to burns will be included, and those with scaling and open wounds in scar tissue will be included, pregnant women and patients who have previously used any therapeutic resource that may have altered the remodeling process of the hypertrophic scar. The bandage will be applied on the scar selected by lottery. The intervention group will receive the bandage with a tension around 70% and the group will control the same bandage without tension. This feature will be used for a period of three to four days. Initial and subsequent evaluations will be performed after 45 and 90 days. Primary outcome: analysis of the inflammatory response. Through immunohistochemistry and the histological evaluation of the organization pattern of collagen fibers. Secondary: aesthetic and functional evaluation of the hypertrophic scar through the Vancouver scale. The statistical analysis will be done by the researcher and his collaborators, in addition to the statistical one, using the statistical programs Epi-Info 3.5 and Medcalc. For categorical variables, where appropriate, use of the chi-square test of association and Fisher's exact test. Regarding the quantitative variables, the unpaired samples were Student's t-test and if the distribution is not normal, the Mann-Whitney test will be used.
Currently, there are limited prevention or treatments available for dyschromia in burn hypertrophic scars (HTSs). The limited available techniques involve transferring melanocytes from unaffected areas to the scar to adjust pigment. These techniques involve the creation of a donor site and do not utilize the cells that may already be present in scars. This study aims to confirm melanocyte presence in regions of hypo- and hyper- pigmented HTS. If melanocytes can be found in regions of hypopigmentation, these scars may be able to be treated in the future by pigmentation stimulators without the need for surgery. Additionally, if pigmentation specific molecules of interest can be found to be up-regulated in hyperpigmented scar, these may be able to be altered by a pharmacotherapy.
A Phase II prospective, randomized, double-blind, placebo controlled and comparative clinical study evaluating hydrogel scar-management modalities for effective management of hyperproliferative scars and keloids. This is a double-blinded study, which means that neither the evaluating physician nor the subject will know which treatment is administered. Group selection and assignment will be made at random, with a 2 in 5 chance of receiving a market-approved therapy, and 1 in 5 chance of receiving the placebo. Subjects assigned the placebo-moisturizer will receive a standard hypoallergenic dermatological hydrating cream base. Subjects assigned the silicone gel, will receive a commercially available, active comparator.
The purpose of this study is to explore the effects of pulsed dye laser on managing scar vascularity and thickness.
Pressure therapy (PT) and silicone therapy are recommended as first-line non-invasive treatment for Hypertrophic Scar (HS), yet the effectiveness of the combination of these two treatments through an RCT trial has not been established yet. This study aims to examine the effectiveness of the combination of adequate pressure therapy and silicone gel sheeting implemented by Smart Scar Care Pad (SSCP) + conventional Pressure Garment (PG) versus conventional Pressure Garment (PG) alone in the management of HS in adult with total hip replacement (THR) and total knee replacement (TKR). This study also aims to find out the prevalence of hypertrophic scar among patients with THR and TKR. This study is a randomised controlled trial with two parallel arms, with allocation ratio (Experimental: Control) of 1: 1 in order to establish the superiority of SSCP + PG over PG. Subjects with hypertrophic scar will be randomly assigned to either treatment or control group. The subjects in the treatment group will be provided with the SSCP and PG for treatment, whereas the subjects in the control group will be prescribed only the PG. The treatment will last for a total of 6 months. A variety of objective outcome measures will be used to analysis the treatment effect.
Skin scarring (fibrosis) is a common complication in the wound healing process and remains a therapeutic challenge. Scar formation often occurs following injury to the skin such as surgery, trauma, and burns. The goal of this study is to evaluate the safety and efficacy of visible red light as a modality to reduce skin scarring after mini-facelift surgery. Based on laboratory data, light emitting diode-red light (LED-RL) phototherapy may lessen post-surgical skin fibrosis clinically.