Clinical Research Directory

Reallocating Rehabilitation Time to Wii Fit or Pilates After Lower-Limb Burn Injury

This randomized controlled trial will evaluate whether reallocating part of a fixed-duration supervised rehabilitation session to Wii Fit or Pilates will improve functional outcomes in adults with healed lower-extremity burns. Participants will be randomly assigned to Wii Fit, Pilates, or conventional rehabilitation and will receive 60-minute supervised sessions three times weekly for 12 weeks. Walking capacity, postural stability, functional mobility, and quadriceps muscle performance will be assessed at baseline, after the 12-week intervention, and 12 weeks after completion of supervised rehabilitation. The study will compare these time-matched rehabilitation approaches and will assess the persistence of functional changes during the subsequent follow-up period.

Understanding the Burn Wound Microbiome: Comparing Traditional Wound Cultures to Next Generation Sequencing Technology

The purpose of this investigation is to better understand the wound microbiome in burn wounds and the role it plays in outcomes and complications related to treatment.

VR-PAT and fNIRS to Identify CNS Biomarkers of Pain

This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR).

Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft

Investigators hypothesize that topical tranexamic acid will have better or comparable efficacy to topical thrombin in reducing hematoma formation at the wound base. The purpose of the study is to demonstrate that topical tranexamic acid will be a non-inferior alternative medication to the current standard of care,THROMBIN-JMI® , and at a lower cost to the health system.

A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds

This is a prospective, randomized, controlled, multi-center clinical study comparing SupraSDRM® to standard of care wound dressing, BTM, in the treatment of full-thickness wounds deemed not immediately suitable for definitive grafting will be performed.

Manual Implantation of Full-Thickness Skin Microcolumns

The objective of this study is to validate the proof of concept regarding the approach of manual implantation of full-thickness skin microcolumns (FTSMs) as coverage for open wounds without creating an additional donor scar and while also capitalizing on the wound healing benefits offered by full-thickness skin grafts.

Reducing Pain and Anxiety During Dressing Changes After Burn Surgery Using Virtual Reality

Burn injury and its treatment is an intensely painful experience. Most severely injured patients require numerous dressing changes and skin grafting procedures (removing skin from healthy part of the body and moving it to damaged area of the body). This procedure cause extensive pain and anxiety and many patients can become dependent on pain killers during their hospital stay and throughout rehabilitation. This can delay reintegration into society and increase the chance of opioid dependence. An effective pain management plan plays a large role in patient recovery. In addition to the physical pain experienced by these patients, burn injury is an intensely stressful and emotional life experience. This study will use a non-drug approach to reduce pain and extensive use of pain killers (opioids) during dressing changes. In particular, the study will use an immersive (allows to experience computer-generated environment as a real world) Virtual reality (VR) distraction tool during dressing change after skin graft surgery. Individuals who will decide to participate in this study will be asked to wear headgear to view immersive 360 videos specially designed by the study team. Before and after this exposure participants will be asked to complete a measurement of their anxiety level (VAS) and rate their pain. This study will help to determine if using VR as a distraction tool during painful dressing changes will reduce pain and anxiety, and therefore opioid medications requirements, and will rely on participants experience and adapt VR videos according to participants' response.

Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds

The purpose of this study is to determine the effect to which Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany) can reduce the need for grafting compared to Standard of Care (SoC). Furthermore, the study intends to evaluate if Suprathel® allows for a reduction of reduction of pain, infection, provider workload, scar development and costs compared to SoC.

Phase III Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents

This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in patients with deep partial and full-thickness burns as compared to split-thickness skin.

Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children

This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in children with partial deep dermal and full thickness burns.

Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents

This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and adolescents with partial deep dermal and full thickness burns.

SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma

This clinical trial is designed to assess the safety, effectiveness and benefits of Self Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of full-thickness burn wounds that require permanent coverage where the availability of donor sites is limited.

Effects of the Mobile Application Developed for Families After the Earthquake on First Aid Knowledge and Burn Prevention

The aim of this project was to determine the effect of the burn prevention and first aid mobile application developed for families living in tent cities and container houses after the earthquake on the burn prevention and first aid knowledge of families and the development of burns in the first two months after the mobile application. The research was planned as a prospective, two-arm (1:1), randomized controlled trial. The study population will consist of families living in tent cities and container houses in Şanlıurfa. As a result of the power analysis performed in the G\*Power program, the sample group will consist of 30 families from the tent city and 30 families from the container city, taking into account the losses with a power of 90% and a maximum bidirectional 5% type error. All of the families (30 mobile application-study group; 30 control group) who make up the sample of the research will be given a training (powerpoint presentation) prepared by the researcher in line with the literature, and burn prevention and first aid practices will be explained and their questions will be answered. Then, the training to be given with the mobile application will be downloaded to the phones of the families in the experimental group and the training will continue through the application. In the study, data will be collected with the "Descriptive Characteristics Form", "Information Form on Burn Prevention and First Aid" and "Burn Development Follow-up Form", which include the descriptive information of the families. The data obtained from the study will be analyzed in computer environment.

Integrated Case Management for Burns Care in Pakistan

To test whether a culturally adapted multicomponent intervention for improving burns care and patient/family rehabilitation is effective in improving survival among burn victims in Pakistan and is cost-effective. The comparator will be usual care plus brief written self-help advice (enhanced usual care). The study is designed as a multicentre, pragmatic, parallel group, individually randomised trial. Participants in the intervention arm will receive 8 sessions delivered by the case managers (6 low-intensity sessions lasting 30-60 minutes in the hospital/community and 2 follow-up sessions lasting 30 minutes in the community). Assessments will be conducted at baseline, at 3 months, 6 months and at 12-months post-intervention.

VR-PAT During Home Burn Dressings - Multisite

This study will evaluate the effectiveness of smartphone Virtual Reality Pain Alleviation Therapy (VR-PAT) as a pain distraction tool during repeated at-home burn dressing changes among 100 children (age 6-17 years) with a burn injury in comparison to 100 children with a burn injury who do not use the VR-PAT.

Autologous Point-of-Care Adipose Therapy: Recent Injury

The goal of this study is to explore if an adipose-based therapeutic strategy can treat full-thickness soft-tissue trauma wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are: \- Can immediate autologous adipose and autologous layered composite grafting be effective for acute functional soft-tissue reconstruction? Researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk. Participants will: * Receive immediate fat grafting into the wound. * Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.

Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar

The goal of this study is to explore if an adipose-based therapeutic strategy can treat contracted scars secondary to soft-tissue burn wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are: \- Can autologous layered composite grafting demonstrate non-inferiority compared to full-thickness skin grafting for delayed reconstruction of post-burn or trauma scar contracture? Researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk. Participants will: * Receive fat grafting at time of scar revision. * Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.

Gaming Based PNF on Spatiotemporal Parameters in Upper Limb Burned Patients

Burn injuries are among the most severe forms of trauma, often leading to significant physical and psychological challenges. The rehabilitation process for burn patients, particularly those with upper limb injuries, is complex due to the need for restoring functional movement and reducing scar contracture. Traditional rehabilitation methods focus on restoring range of motion, muscle strength, and coordination. However, these approaches can be limited in engaging patients and maintaining their motivation throughout the recovery process.

Foreign-National Burn Patients in a Border-Region Burn Center

This retrospective cohort study will evaluate burn patients hospitalized and treated at the Burn Center of Gaziantep City Hospital between October 2023 and June 2026. The study aims to compare demographic characteristics, burn severity, clinical course, and in-hospital outcomes between Turkish citizens and foreign-national burn patients. Data will be obtained retrospectively from patient files, discharge summaries, intensive care records, operative notes, and the hospital information management system. Variables will include age, sex, nationality status, burn etiology, total body surface area burned, inhalation injury, sepsis, intensive care unit admission, mechanical ventilation requirement, surgical treatment requirement, number of operations, length of hospital stay, discharge status, transfer to another center, and in-hospital mortality. No additional intervention, diagnostic test, treatment, or follow-up procedure will be performed as part of this study. All analyses will be conducted using anonymized or coded retrospective clinical data.

Differential Pressure Distribution Orthosis by 3D Printing Process in the Treatment of Post-burn Hypertrophic Scarring

This is a pilot, single-center, feasibility study to evaluate a new 3D printing method for ORDP design. To our knowledge, there is no technical or clinical evaluation of ORDPs, particularly in the treatment of hypertrophic scars. The aim of our study is therefore to assess the feasibility of an innovative method of designing ORDPs for the curative treatment of post-burn hypertrophic scars, using a 3D printing process, and to describe the procedures (production time and cost).

Whole-Body Vibration Training On Thermal Burn Injury In Pediatrics

60 Patients with partial and full thickness thermal burns of the lower limb and trunk will be indiscriminately assigned to study group Group A(Study group): 30 patients received whole body vibration training on a vibration platform 12-15 minutes, 5 times per week, plus traditional physical therapy exercise program in the form of 60 minutes supervised exercise program for 8 weeks. Group B (control group):30 patients will receive a traditional physical therapy program. The program consists of 60 minutes of supervised stretching exercise to all involved joints followed by strengthening for affected muscles for 8 weeks.

THERAVEX Tissue Care Spray Plus for the Management of Cutaneous Wounds, Burns, and Chronic Ulcers

Pilot observational clinical evaluation assessing the safety and potential effectiveness of THERAVEX Tissue Care Spray Plus as an adjunctive topical therapy for the management of cutaneous wounds, burns, traumatic lesions, pressure ulcers, diabetic ulcers, and chronic ulcers in 26 patients. The study evaluated wound healing progression, epithelialization, tissue hydration, inflammatory response, tolerance, and overall clinical evolution in patients receiving standard wound care combined with topical application of THERAVEX Tissue Care Spray Plus. Preliminary observations demonstrated favorable tissue response, progressive epithelial regeneration, reduction of inflammatory signs, and absence of treatment-related adverse events.

Frenkel Exercises on Balance and Quality of Life Post Burns

Seventy patients of both sexes with thermal burn injuries, aged 25 to 45 years, will participate in this study. The participants will be randomly selected from the Outpatient Clinic of the Faculty of Physical Therapy. They will be randomly assigned into two equal groups, 35 patients each (study group and control group). Group A (Study Group): Patients in this group will receive Frenkel exercises in addition to a traditional physiotherapy program comprising stretching, strengthening exercises and scar management, 3 times a week for 8 weeks. While, Group B (Control Group): Patients in this group will receive traditional physiotherapy program, 3 times a week for 8 weeks.

Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection

Burn wound infections remain a major source of morbidity in patients with thermal injuries and contribute to delayed healing, graft loss, and prolonged hospitalization. The emergence of antimicrobial-resistant organisms further complicates management and highlights the need for non-antibiotic antimicrobial strategies. Photodynamic therapy (PDT) is an antimicrobial approach that combines a photosensitizing agent with visible light to generate reactive oxygen species capable of killing bacteria. This randomized clinical trial will evaluate the safety and preliminary efficacy of methylene blue-mediated photodynamic therapy for the treatment of burn wound bacterial contamination. Participants receiving standard burn care will be randomized to receive either methylene blue-photodynamic therapy with blue light illumination or light therapy alone during routine dressing changes. Treatments will occur during two consecutive dressing changes. The primary objective is to determine whether methylene blue photodynamic therapy reduces bacterial burden in burn wounds compared with light therapy alone. Secondary outcomes include safety, tolerability, and effects on wound healing.