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NCT07453927
Background: The donor site (DS) in patients with severe burns is often associated with complications that may delay healing and negatively affect clinical outcomes. Impaired re-epithelialization, pain, inflammation, and risk of infection represent relevant challenges in burn care. Blue light (BL) photobiomodulation has demonstrated beneficial effects in different types of skin lesions, including modulation of inflammation and stimulation of tissue repair. Therefore, BL therapy may represent an innovative and non-invasive strategy to enhance DS healing and improve overall recovery. Methods: This protocol describes an interventional, controlled, prospective, single-center, post-market clinical study enrolling 25 patients with intermediate and deep burn injuries. A CE-marked device emitting BL will be used. Each participant will receive both treatments through an intra-patient controlled design: one DS area will be treated with Standard of Care (SoC) alone, while a second DS will receive SoC combined with BL therapy. This approach allows direct comparison of clinical outcomes within the same patient, minimizing inter-individual variability. The primary outcome is the comparison of DS healing time between areas treated with BL plus SoC and those treated with SoC alone. Secondary outcomes include assessment of wound bed characteristics using the Wound Bed Score (WBS), evaluation of pain intensity during the healing process through the Numeric Pain Rating Scale (NRS), and identification of clinical signs of infection by performing skin swabs on both treated and untreated areas. Safety will be assessed by monitoring local adverse reactions related to BL exposure, such as erythema, burning sensation, heat perception, skin irritation, or pruritus. Long-term scar quality will be evaluated at 1 and 3 months after complete healing using the Vancouver Scar Scale (VSS), allowing comparison of aesthetic and functional outcomes between the two treatment approaches. Follow-up visits at 1 and 3 months will also enable detection of late adverse events and confirmation of the persistence of therapeutic effects. Discussion/Conclusion: BL photobiomodulation appears to be a promising and well-tolerated adjunctive therapy for DS management in burn patients. This study aims to generate clinical evidence supporting its effectiveness and potential integration into routine burn care practice.
NCT07330154
The goal of this clinical trial is to assess the effect of Nano-biofusion gingival gel (NBF) on wound healing at the palatal donor site following soft tissue graft surgery and compare it to placebo gel. The main questions it aims to answer are: * Does NBF gel enhance wound healing after graft harvesting from the palate? * Does NBF gel reduce the number of inflammatory mediators after surgery? * Does NBF gel reduce pain and discomfort at the palatal donor site? Researchers will compare NBF gel to a placebo (a look-alike gel that does not contain the active ingredients) to see if NBF gel enhances wound healing. Study steps include: * Participants will apply the assigned gel on the surgical wound 4 times a day for 4 weeks. * Clinical photographs and measurements will be obtained on days (0, 1, 2, 4, 7, 15, 21, 30). * Wound fluid samples will be collected on days (0, 1, 2, 4, 7). * Participants will be asked about the level of pain and analgesic consumption on each follow-up visit.
NCT04050124
The purpose of this study is to assess the feasibility of evaluating the use of a composite collagen, silver-oxidized regenerated cellulose matrix compared to the standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.
NCT04867070
Laparoscopic living donor nephrectomy (LLDN) is a safe procedure and rapid wound healing, affecting the quality of life. The physiology of postoperative pain after LLDN has been attributed to reasons such as tissue damage, residual pneumoperitoneum, and diaphragm irritation. In terms of patient comfort after LLDN, pain control is provided by IV analgesics, local anesthetic injection instead of incision, and regional techniques. Regional anesthesia techniques for postoperative pain control have become popular in recent years. Today, many blocks are performed with ultrasonography (USG) to reduce the severity of pain after laparoscopic and open surgeries. In 2016, Forero et al. erector spinae plane block (ESPB) had been defined and used successfully in thoracic and abdominal surgeries. In our clinic, peripheral nerve blocks such as intravenous patient-controlled analgesia (PCA) and ESPB are applied for postoperative analgesia. The method of analgesia is suitable for the surgery and explained to the patients. This study; In LLDN operations, it was aimed to compare the bilateral ESP block performed with USG in terms of postoperative pain scores and opioid analgesic consumption compared to patients without any block. Before the operation, the anesthesiologist in charge of the anesthesia outpatient clinic provides information about both anesthesia and postoperative pain management methods suitable for surgery. This is the standard practice in our clinic. Before anesthesia, anesthesia and analgesia methods will be briefly reminded to the patient who has come for the operation. He/she will be asked if he/she wants to apply postoperative analgesia. Block procedure will be applied to patients who want ESP block. Standard analgesia will be applied to all patients. Regardless of the study, patients who underwent LLDN operation will be interviewed in the postoperative period with or without an ESP block for postoperative analgesia. The data and postoperative evaluations of the patients who agreed to participate in the study will be recorded for study purposes. The patient data will be taken from the hospital registration system.
NCT04490213
The aim of this study was to investigate if previous findings on the association between dressing treatments and subjective opinion on final donor site scar outcome using the patient scale of POSAS could be confirmed objectively. Scar outcome measurements were assessed by a blinded observer using POSAS and the device: Cutometer dual MPA 580 (Courage and Khazaka Electronic GmbH, Cologne, Germany) to measure the viscoelasticity of the skin.