Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06151769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-11-14
Brief Title:
The Effect Pomegranate Seed Oil Prevention and Progression Pressure Ulcers in Intensive Care Patients
Sponsor:
TC Erciyes University
Organization:
TC Erciyes University
Study Overview
Official Title:
The Effect of Topical Pomegranate Seed Oil on Prevention and Progression of Control Pressure Ulcers in Intensive Care Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 81-41 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 155 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 265 and 8757 per dayThe care provided due to developing pressure sores increases the burden on healthcare professionals and makes it difficult to achieve the desired quality of careIt also brings an extra financial burden to care institutionsStudies 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
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 265 and 8757 per dayThe care provided due to developing pressure sores increases the burden on healthcare professionals and makes it difficult to achieve the desired quality of careIt also brings an extra financial burden to care institutionsStudies 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
Detailed Description:
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 have acute or chronic diseases While the incidence of pressure ulcers in hospitals is 10-23 this rate has been reported to be 81-41 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 155 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 sore treatment in addition to normal treatment increased the per capita cost of care between 265 and 8757 per day According to data published in the National Pressure Ulcer Advisory Panel NPUAP in 2016 it has been reported that the frequency of pressure ulcers in the United States is between 13-3 million and its annual cost is around 22-36 billion dollars When the situation in pressure sores in our country is examined it was determined that the average number of patients with pressure sores annually is 25 million and the annual cost of these patients to the country is 115 billion dollars
The care provided due to developing pressure sores increases the burden of 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 To prevent all this in recent years various initiatives have been undertaken in clinical areas to prevent pressure sores and heal wounds mainly based on the application of evidence-based guidelines According to studies it has been determined that different methods are used for the prevention and healing of pressure sores In experimental or quasi-experimental studies conducted according to different methods it was found that the development of pressure sores was not affected and in other studies it was found that it did not provide an effective change in prevalence but reduced the incidence A study on the prevention of pressure sores pressure-relieving mattresses and planned repositioning anodal and cathodal-anodal electrical stimulation in category II-IV pressure sores chronic The effects of negative pressure vacuum-assisted closure technology on the rapid healing of wounds were examined Again such as the effect of laser treatment on angiography fibrogenic factors and cytokine concentrations during the healing process of pressure sores and stem cell therapy in skin wound healing methods were used However no definitive method to treat and prevent pressure sores has been discovered so far
The use of complementary medicines including medicinal plants has long been recommended in this regard Recent approaches in medicine recommend its use in the prevention and treatment of diseases because it has fewer side effects and it is welcomed by patients In a study examining the effect of olive oil on preventing pressure sores in bedridden patients it was determined that the use of olive oil could be an effective method
Assessment and care of the skin is important in preventing pressure sores Dry skin is very effective in the development of pressure sores In another study aloe vera gel was applied to patients at risk of developing pressure sores in orthopedic clinics No symptoms such as increased temperature redness or swelling were observed in the areas where aloe vera gel was applied Therefore it can be applied to prevent pressure sores Smooth skin is more resistant to external pressures
Pomegranate seed oil is very rich in conjugated fatty acids linoleic and linolenic fatty acids It is reported that pomegranate seed oil is effective in preventing prostate and skin cancer and reducing lipid levels in the liver Pomegranate seed oil which has a very high vitamin E content is also rich in antioxidant polyphenols In a study conducted with vitamin E it was found to be effective in oral mucositis preventive and therapeutic oral care practices
In addition to these effects pomegranate seed oil is one of the rare products that contain conjugated fatty acids In a randomized controlled study examining the effect of pomegranate seed oil supplementation on Glucose transporter type 4 GLUT-4 gene expression and glycemic control in obese people with type 2 diabetes it was found to significantly increase Glucose transporter type 4 GLUT-4 gene expression In a study examining the effect of pomegranate seed oil on serum Tumor necrosis factor TNF-α level in dyslipidemic patients it was found that orally administered pomegranate seed oil did not affect serum Tumor necrosis factor TNF-α level in patients with dyslipidemia In another study examining the effect of pomegranate seed oil on hyperlipidemic subjects it was found that oral pomegranate seed oil given for 4 weeks had a positive effect on the lipid levels of the patients As can be seen although the effectiveness of pomegranate seed oil has been investigated in many subjects in the literature review there is no study examining its effectiveness in preventing and healing wound development
The aim of this study is to examine the effect of topical pomegranate seed oil application on pressure ulcer development and progression
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 sore treatment in addition to normal treatment increased the per capita cost of care between 265 and 8757 per day According to data published in the National Pressure Ulcer Advisory Panel NPUAP in 2016 it has been reported that the frequency of pressure ulcers in the United States is between 13-3 million and its annual cost is around 22-36 billion dollars When the situation in pressure sores in our country is examined it was determined that the average number of patients with pressure sores annually is 25 million and the annual cost of these patients to the country is 115 billion dollars
The care provided due to developing pressure sores increases the burden of 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 To prevent all this in recent years various initiatives have been undertaken in clinical areas to prevent pressure sores and heal wounds mainly based on the application of evidence-based guidelines According to studies it has been determined that different methods are used for the prevention and healing of pressure sores In experimental or quasi-experimental studies conducted according to different methods it was found that the development of pressure sores was not affected and in other studies it was found that it did not provide an effective change in prevalence but reduced the incidence A study on the prevention of pressure sores pressure-relieving mattresses and planned repositioning anodal and cathodal-anodal electrical stimulation in category II-IV pressure sores chronic The effects of negative pressure vacuum-assisted closure technology on the rapid healing of wounds were examined Again such as the effect of laser treatment on angiography fibrogenic factors and cytokine concentrations during the healing process of pressure sores and stem cell therapy in skin wound healing methods were used However no definitive method to treat and prevent pressure sores has been discovered so far
The use of complementary medicines including medicinal plants has long been recommended in this regard Recent approaches in medicine recommend its use in the prevention and treatment of diseases because it has fewer side effects and it is welcomed by patients In a study examining the effect of olive oil on preventing pressure sores in bedridden patients it was determined that the use of olive oil could be an effective method
Assessment and care of the skin is important in preventing pressure sores Dry skin is very effective in the development of pressure sores In another study aloe vera gel was applied to patients at risk of developing pressure sores in orthopedic clinics No symptoms such as increased temperature redness or swelling were observed in the areas where aloe vera gel was applied Therefore it can be applied to prevent pressure sores Smooth skin is more resistant to external pressures
Pomegranate seed oil is very rich in conjugated fatty acids linoleic and linolenic fatty acids It is reported that pomegranate seed oil is effective in preventing prostate and skin cancer and reducing lipid levels in the liver Pomegranate seed oil which has a very high vitamin E content is also rich in antioxidant polyphenols In a study conducted with vitamin E it was found to be effective in oral mucositis preventive and therapeutic oral care practices
In addition to these effects pomegranate seed oil is one of the rare products that contain conjugated fatty acids In a randomized controlled study examining the effect of pomegranate seed oil supplementation on Glucose transporter type 4 GLUT-4 gene expression and glycemic control in obese people with type 2 diabetes it was found to significantly increase Glucose transporter type 4 GLUT-4 gene expression In a study examining the effect of pomegranate seed oil on serum Tumor necrosis factor TNF-α level in dyslipidemic patients it was found that orally administered pomegranate seed oil did not affect serum Tumor necrosis factor TNF-α level in patients with dyslipidemia In another study examining the effect of pomegranate seed oil on hyperlipidemic subjects it was found that oral pomegranate seed oil given for 4 weeks had a positive effect on the lipid levels of the patients As can be seen although the effectiveness of pomegranate seed oil has been investigated in many subjects in the literature review there is no study examining its effectiveness in preventing and healing wound development
The aim of this study is to examine the effect of topical pomegranate seed oil application on pressure ulcer development and progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None