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Pressure Ulcer clinical trials

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NCT ID: NCT06384183 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Kerecis Real World Registry

Start date: July 2024
Phase:
Study type: Observational [Patient Registry]

Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices

NCT ID: NCT06369688 Not yet recruiting - Pressure Ulcer Clinical Trials

IDEAL SKIIN CARES Bundle to Prevent Pressure Injury

IdealSkinCares
Start date: October 1, 2025
Phase: N/A
Study type: Interventional

The study will be a multi-center, triple-blinded, cluster randomized controlled trial (c-RCT) conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group, where patients will receive training in relevant pressure injury care bundles, and the placebo group, where patients will receive training in an irrelevant topic like respiratory care. Both intervention and placebo groups will receive specialized pressure injury prevention (PIP) care bundle from trained wound specialist nurses (WSNs). The third arm will be the control group comprising patients who do not undergo any training course and will receive only routine standard care for PIP care bundle. The aim of c-RCT will be to compare the incidence of hospital-acquired pressure injury (HAPI) in the three study groups and to provide detailed evidence on the effect of the developed pressure injury care bundle, administered by WSNs on the development of HAPI in trained hospitalized patients, as opposed to those receiving routine standard care for PIP care bundle without training.

NCT ID: NCT06330506 Not yet recruiting - Pressure Ulcer Clinical Trials

The Effect of Pressure Ulcer Care Package on the Risk of Pressure Ulcer Development

Start date: April 10, 2024
Phase: N/A
Study type: Interventional

This study aimed to determine the effect of pressure ulcer care package use on the risk of pressure ulcer development due to surgery in patients undergoing orthopedic surgery. It was planned as a randomized controlled study. The population of the study will consist of patients who underwent surgery in the Orthopaedics and Traumatology Clinic of Doğubayazıt Dr.Yaşar Eryılmaz State Hospital Hospital Hospital of Ağrı Provincial Health Directorate. The sample of the study will consist of patients who volunteered to participate in the study that meets the inclusion criteria. To obtain research data, the Personal Information Form developed by the researcher in line with the literature, 3S Operating Theatre Pressure Wound Risk Assessment Scale, Pressure Wound Regions and Stages Monitoring Form prepared according to NPUAP (2016) Pressure Wound Staging System Form will be used. Statistical analysis of the data obtained from the study will be performed using the SPSS 25 (Statistical Package of Social Science) package program.

NCT ID: NCT06283979 Not yet recruiting - Osteomyelitis Clinical Trials

A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.

BLADE OPU2
Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.

NCT ID: NCT06243328 Not yet recruiting - Pressure Sores Clinical Trials

Effect of Negative Wound Pressure on P.S

Start date: February 2024
Phase: N/A
Study type: Interventional

This study will compare the NPWT using the NPD to the conventional wound dressing and specifically evaluating (i) reduction of wound surface area and depth, (ii) removal of slough and formation of granulation tissue

NCT ID: NCT06151769 Not yet recruiting - Pressure Ulcer Clinical Trials

The Effect Pomegranate Seed Oil Prevention and Progression Pressure Ulcers in Intensive Care Patients

Start date: February 18, 2024
Phase: N/A
Study type: Interventional

Pressure sores are an important health problem that can be seen at any age and in any environment where care is provided, especially in intensive care units. It is a problem that can frequently develop, especially in people who are bedridden for long periods of time and who have acute or chronic diseases. While the incidence of pressure ulcers in hospitals is 10-23%, this rate has been reported to be 8.1%-41% in intensive care units. In Turkey, the incidence of pressure ulcers in patients receiving mechanical ventilation treatment for at least 24 hours was found to be 17% and 15.5% in intensive care units. It is an important problem that requires long-term care and treatment after the development of a pressure sore, prolongs the duration of hospitalization, has high treatment and care costs, and increases morbidity. In a systematic review, it was stated that pressure ulcer treatment, in addition to normal treatment, increased the per capita cost of care between € 2.65 and € 87.57 per day.The care provided due to developing pressure sores increases the burden on healthcare professionals and makes it difficult to achieve the desired quality of care.It also brings an extra financial burden to care institutions.Studies have found that pressure ulcer development increases the cost of nursing care. Pressure sores also cause pain, infection, etc. in patients. It leads to the development of serious problems, deterioration in comfort and a significant decrease in the quality of life. The use of complementary medicines, including medicinal plants, has long been recommended in this regard. The latest approaches in medicine recommend its use in the prevention and treatment of diseases due to its fewer side effects, and it is welcomed by patients. Assessment and care of the skin is important in preventing pressure sores. Pomegranate seed oil is very rich in conjugated fatty acids (linoleic and linolenic fatty acids). Although the effectiveness of pomegranate seed oil has been investigated in many subjects, there is no study examining its effectiveness in preventing and healing wound development. The aim of this study is to determine the application of topical pomegranate seed oil. To examine its effect on pressure sore development and progression. To determine the effect of topical pomegranate seed application on the prevention and progression of pressure sores. It will be conducted as a randomized controlled experimental study.

NCT ID: NCT05979402 Not yet recruiting - Healthy Clinical Trials

The Effect of Pressure Ulcer Education on the Knowledge Level of the Relatives of the Patients

Start date: August 10, 2023
Phase: N/A
Study type: Interventional

The purpose of this randomized controlled trial, which included pretest and posttest, was to examine the effectiveness of pressure ulcer prevention and care education given to caregivers of patients treated in a palliative care clinic. The key questions it aims to answer are: - Does the routine clinical training given in the palliative care clinic have an effect on the knowledge level of patients' relatives about pressure ulcers? - Does the pressure ulcer education given to the relatives of patients treated in the palliative care clinic have an effect on the level of knowledge about pressure ulcers? Participants will participate in an educational activity on pressure ulcers. Researchers will compare whether pressure ulcer training given to palliative care patient relatives is effective compared to routine service training with lecture, question-answer and presentation method.

NCT ID: NCT05946291 Not yet recruiting - Pressure Injury Clinical Trials

Simulation Applications on the Level of Pressure Injury Knowledge and Evaluation

Start date: May 15, 2024
Phase: N/A
Study type: Interventional

When the literature is examined, it is seen that the pressure injury knowledge and evaluation levels of nursing students are low. Today, innovative approaches have started to be introduced to nursing education in proportion to the development of technology. Simulation applications are also seen as one of these innovative approaches. In our study, it is aimed to examine the effect of pressure injury training to be given using high-reality standardized patient use and a medium-reality simulation model on the knowledge and evaluation level of intern nursing students. Students (n = 250) will be assigned blindly to the experimental and control groups using a simple randomization method, and then pressure injury information and assessment trainings will be given to the experimental group with a medium-reality simulation model on a standardized patient for the control group for 4 weeks. After 2 weeks, the final test will be performed, and the data will be assigned to blind groups. It will be evaluated by the researcher.

NCT ID: NCT05880290 Not yet recruiting - Medical Care Clinical Trials

Performance of the Gynaecological Examination in the Lateral Decubitus Position

EXADELA
Start date: June 2023
Phase: N/A
Study type: Interventional

The gynaecological examination consists of a breast examination, abdominal examination, inspection of the vulva, vaginal touch and pelvic examination with a speculum. The latter is essential for the insertion and removal of intrauterine devices (IUDs), for the diagnosis and screening of pathologies that may cause pelvic symptoms, for assessment of the vaginal wall and for regular screening for cervical cancer. The gynaecological examination is feared by many women because of the feeling of exposure, vulnerability and loss of control. The parallel with a sexual position is particularly disturbing for patients who do not want to see this representation mixed with a medical necessity, which can lead some women to have irregular or even discontinued follow-up. For the past ten years, medical practice theses and midwifery dissertations have evaluated the interest of another position for the pelvic examination with the speculum : the lateral decubitus position in which the patient lies on her side. The lateral decubitus pelvic examination seems to be an alternative for comfort and respect for modesty, which is favoured by the patients. This examination position would have advantages in situations of anterior anatomical position of the position of the cervix, prolapse, severe obesity, hip pathology or significant reluctance to the examination. The effectiveness of this technique in terms of examination performance needs to be evaluated to promote its dissemination. The impact of an examination that is better experienced by patients is that of better adherence and therefore better follow-up, which is the particular challenge of primary care. Single group: gynaecological examination in lateral decubitus, conventional repositioning if unsuccessful

NCT ID: NCT05649332 Not yet recruiting - Burn Wound Clinical Trials

Study to Evaluate the Performance and Safety of the Medical Device Argogen

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

A wound, i.e., a break in the skin, can result from several reasons. Pressure ulcers (also called pressure sores, bed sores and decubitus ulcers) are localized damage to the skin and underlying soft tissue usually over a bony prominence or related to a medical or other device, occurring as a result of intense and/or prolonged pressure or pressure in combination with shear. Burn wounds result from traumatic injuries to the skin or other tissues primarily caused by heat, electrical discharge, friction, chemicals, or radiation. Burns are acute wounds caused by an isolated, non-recurring insult. The Medical Device Argogen® (adsorbing spray powder for exudates with silver ions) consists of silver zeolite powder, combining in a single physical form the adsorbing properties of the zeolite structure and the antimicrobial properties of silver. Its action is due to the porous structure of zeolite that actively absorbs and control wounds exudate, keeping clean and dry the environment of small skin lesions, as wounds, abrasions, minor burns and bedsores. The association with silver ions gives to the medical device the additional property of an antimicrobial effect. The present study is to confirm that in a population of men and women presenting minor burn wounds (superficial or superficial / deep partial thickness) or chronic pressure ulcers stage 2 or 3 - NPUAP Classification (partial-thickness skin loss with exposed dermis or full-thickness skin loss) the medical device already CE marked Argogen® (adsorbing spray powder for exudates with silver ions) safely attests its capacity to promote wound healing, evaluated as percentage (%) of subjects with objective signs of wound healing (evaluated by mean of VSS score reduction for burn wounds or PUSH tool score reduction for pressure ulcers), results observed after 2 and 4 weeks after the beginning of the treatment.