Clinical Research Directory

The Use of Photobiomodulation for Pain and Healing in Cesarean Section

Good incisional wound healing and postoperative pain are the primary concerns regarding cesarean delivery, as it can lead to serious complications and delayed recovery for patients. Both pharmacological and non-pharmacological interventions have been investigated to promote effective analgesia and favorable healing of the cesarean surgical incision. Among the therapies under investigation for this purpose, photobiomodulation (PBM) stands out. Photobiomodulation consists of the use of low-intensity therapeutic light, and several publications have emphasized its analgesic properties and its capacity to promote wound healing across various etiologies. This study aims to evaluate the analgesic and wound-healing effects of PBM on the skin surgical incision following cesarean section. This will be a randomized controlled clinical trial in which 30 women undergoing elective cesarean delivery will be randomly allocated into two groups: a control group or a photobiomodulation group. All participants will receive standard hospital treatment for analgesia and postoperative wound care, combined with an active PBM protocol consisting of 3 J per point (658 nm) applied to the incisional area and 4.5 J per point (830 nm) applied around the wound, delivered immediately postoperatively, as well as 24 and 48 hours after surgery. The control group will undergo PBM with the laser device turned off, using the same protocol. Patients will be assessed before and after each PBM session, at 24 and 48 hours, and at 5, 10, and 40 days postpartum, to evaluate pain intensity using the Visual Analog Scale (VAS) and the McGill Pain Questionnaire, as well as wound healing using the REEDA scale. Clinical wound characteristics, epidemiological data, analgesic consumption during the inpatient period, and the occurrence of adverse events will be used as secondary outcomes. A two-way repeated-measures ANOVA will be used for comparisons between groups and across time points.

Effectiveness and Costs of Pressure Ulcer Treatment and the Quality of Life of Patients With Pressure Ulcers Receiving Home-Based and Institutional Care

A study aimed at comparing the effectiveness of treatment, costs, and quality of life of patients with pressure ulcers in home care and institutional care. Eighty individuals aged 60-90 years with stage II-IV pressure ulcers can participate in the study. Participants will be assessed for factors such as health status, independence, mood, and quality of life. The study will allow for better tailoring care to patients' needs. Other benefits of participating in the study is that the participants will receive a detailed assessment of their health, nutrition, quality of life, as well as support in managing their pressure ulcers. They will receive regular care and medical evaluations, which may positively impact their health and well-being. Refusing to participate in this study will not affect the patients treatment in any way. Please ask if there is anything that is unclear or if you would like additional information. Taking part in this study is entirely voluntary.

Safety Study of Microlyte DualGuard

The primary purpose of this research is to evaluate the safety and effectiveness of Microlyte® DualGuard wound dressing in the healing of partial thickness donor site wounds, also known as skin graft donor sites. This research will assess wound healing, the occurrence of infection, allergic reaction, pain, and itching while subjects are in the hospital and after discharge. Subjects will complete clinic visits through 12 weeks. This research will also assess the occurrence of donor site wound infection, pain and itching, and scarring at 12 weeks, assessed by subjects using the Patient and Observer Scar Assessment Scale (POSAS).

Registry of Outcomes of Dezawa MuseCells®

The goal of this observational study is to learn about the long-term effects of Dezawa MuseCells to treat various diseases. The Primary Goal: What is the short-term and long- term outcomes of Dezawa Musecells? Participants treated with Dezawa MuseCells as part of their regular medical care and will answer online survey questions about symptoms and clinical outcomes for 5 years.

AI-Based Wound Monitoring: Automated Wound Progression Assessment Via Marker-Free Image Sequence

This study aims to develop a low-cost, marker-free intelligent wound assessment system that can analyze wound photos taken with a standard smartphone. By comparing wound images over time, the system will generate a quantifiable Wound Progression Index (WPI) to provide objective feedback on whether a wound is improving, stable, or worsening. The long-term goal is to support early detection of wound deterioration and improve wound care in both clinical and home settings.

The Effect of Wound Care Education Given to Patients on Wound Care Knowledge, Self-Care Self-Efficacy, and Quality of Recovery

This study will be conducted as a randomized controlled trial to determine the impact of artificial intelligence-assisted wound care training provided to patients undergoing prosthetic surgery on their wound care knowledge, quality of healing, and self-care self-efficacy. It was planned to include 22 individuals in the experimental group and 22 in the control group. However, considering the potential for data loss, the study was planned to be completed with a total of 50 individuals: 25 in the experimental group and 25 in the control group. Patient Identification Form, Patient Follow-up Form, Knowledge Level Questionnaire, Self-Care Self-Efficacy Scale and Quality of Recovery (QoR-15) Scale were used to collect data.

Using WoundPilot to Support Wound Care Decisions in Patients With Chronic Wounds

This study evaluates whether a digital decision support tool, called WoundPilot, can help primary care nurses make more accurate and consistent decisions when caring for patients with chronic wounds. In daily practice, treatment decisions for chronic wounds can vary between clinicians, even when they assess the same patient. This variation may lead to delays in appropriate care, inconsistent treatment choices, or unnecessary referrals. WoundPilot was developed to guide clinicians through a structured wound assessment and link this assessment to clear treatment recommendations. In this study, primary care nurses will assess a series of clinical cases either with or without the support of WoundPilot. Their decisions will be compared with an expert reference standard to determine whether the use of WoundPilot improves the accuracy of decisions and reduces differences between nurses. The results of this study will help determine whether WoundPilot can support more consistent and evidence-based wound care in clinical practice.

Plasma Therapy for Diverse Wounds

This study is a prospective, multicenter, real-world observational study. It aims to evaluate whether adding plasma device therapy to standard wound care is effective and safe for treating different types of wounds, including acute wounds (such as burns and surgical incisions), chronic wounds (such as diabetic foot ulcers and pressure injuries), post-grafting wounds, and sutured wounds. A total of 500 patients receiving standard wound care plus plasma therapy will be enrolled from multiple hospitals across China. Their outcomes will be compared with 500 matched patients who received standard wound care alone. The main outcomes include wound healing rate at 4 weeks, time to complete wound closure, pain relief, scar formation, and any side effects. Patients will be followed for up to 6 months.

Child's Interaction With a Social Robot During Dressing

The aim of this randomized controlled trial, consisting of 30 experimental and 30 control groups, was to examine the effect of a child's interaction with a social robot during wound dressing on their fear and pain.

Tele-Exercise Platform for Plantar Wound Healing

The purpose of the study is design and use a telemedicine platform which integrates video-chat, pre-programmed interactive game-based foot, and ankle exercise modules, and real-time quantitative performance metrics displayed to the clinician to improve patient's perfusion to the lower extremity, improve diabetic wound healing and prevent muscle loss in the lower extremity.This is a cross sectional and comparative feasibility study. It is designed to explore acceptability, feasibility and proof of concept/ .

The Pain Reduction Using Immersive Virtual Reality During Wound Care Evaluation Study at Maimonides (PRISM) - Pilot Study

This study will test whether immersive virtual reality (iVR) can reduce pain and discomfort during wound care for residents living in long-term care (LTC). Pressure ulcers are common and painful among older adults, and dressing changes often cause additional distress. Up to 20 residents at the Donald Berman Maimonides Geriatric Centre will use virtual reality headsets during routine wound care. The headsets display calm, low-stimulus scenes (e.g., puppies in a meadow) designed to distract and comfort participants. Each participant will take part for six weeks in three phases: * Two weeks of usual wound care (baseline) * Two weeks using virtual reality during wound care (intervention) * Two weeks of usual care again (washout) Pain will be assessed using validated tools, and the research team will also observe agitation, mood, and other behavioral indicators. Nursing staff will provide feedback on feasibility and acceptability of iVR use in LTC settings.

A PAC Post-Market Clinical Study to Demonstrate Color Change in the WoundCue™ Kit When an Elevated Inhibitory Bacterial and/or Fungal Load is Present in a Wound

The purpose of this research is to test if the investigational ParaNano WoundCue Kit can detect elevated inhibitory bacterial and/or fungal loads.

The Effect of Wound Care Education Using the Jigsaw IV Learning Technique on Nursing Students' Knowledge, Collaborative Learning, and Academic Motivation

This study aims to investigate the effects of wound care education given with the jigsaw IV learning technique on the knowledge, collaborative learning and motivation levels of nursing students. Second-year nursing students will be divided into two groups with simple randomization. The intervention group will be given a wound care training program with the jigsaw IV technique. The control group will be given wound care training with traditional education. Pre-test data will be collected before the training and post-test data will be collected after the training.

Non-pharmacological Pain Care During Complex Wound Care Procedures

The main objective of this study is to evaluate the effect on pain and both Virtual Reality and Music Therapy as add-on therapy during wound car in adults.

Study on the Effectiveness of Hypothermal Sulphurous Water in Wound Hygiene

This is an interventional double arms pilot study on the effectiveness of hydrogen sulfide (H2S) rich and microbiologically pure spa sulphurous water, in the wound hygiene of hard-to heal wounds, set in an italian spa facility. At least 24 subjects enrolled according to selection criteria will be 1:1 randomized in two intervention groups: the former (A) undergoing pack of sulphurous water on soaked gauzes for 20 minutes, the latter (B) undergoing full limb immersion for 20 minutes. Differences among the two arms will be assessed as changes in wound microbiome, wound pH, Trans epidermal water loss (TEWL), 1000x ex-vivo microscope imaging, wound fluorescence imaging for bacterial colonization and longitudinal shifts in wound sizing and peculiar features according to the Bates-Jensen Wound Assessment Tool (BWAT). Time required for re-epithelization will be recorded together with any adverse reactions or events for both arms and compared. The study aims at assessing the effectiveness of hydrogen sulfide exogenous supply on infected or colonized hard to heal wounds and which way of administration (pack Vs immersion) could have prevailing effects.