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

NCT06151769 | Not Yet Recruiting

• 1 other identifier: ErciyesUnı23
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Pressure Ulcer

Keywords

Pressure Ulcer; Pomegranate Seed Oil; Intensive Care

Outcome Measures

Primary Outcomes (4)

• Nutritional Status Control (CONUT score)

  Parameters Normal Light Moderate Severe Serum albümin (g/dl) ≥3.5 3.0-3.49 2.5-2.9 \<2.5 Score 0 2 4 6 Total lymphocyte (count/mm3) ≥1600 1200-1599 800-1199 \<100 Score 0 1 2 3 Total cholesterol (mg/dl) ≥180 140-180 100-139 \<100 Score 0 1 2 3 CONUT score 0-1 2-4 5-8 9-12 Assessment

  first 1 day

• Braden Risk Assessment Scale

  These risk factors are evaluated by nurses and given a score between 6-23. The Braden pressure sore risk assessment scale measures the risk of pressure sores based on total scoring. 6-9 points: Very high risk, 10-12 points: High risk, 13-14 points: Medium risk

  six days

• Ramsay Sedation Scale

  1. Awake and anxious, agitated or restless 2. Awake, cooperative, accepting ventilation, oriented, calm 3. Awake, only responding to commands 4. Sleepy, has a lively/energetic response to light glabellar tapping or loud noise 5. Sleepy, has a dull/sluggish response to light glabellar tapping or loud noise, but no response to painful sleep 6. Sleepy, no response to light glabellar beat or loud sound

  First 1 day

• Patient Follow-up Form

  It was created to record the skin evaluation of patients in the intervention and control groups before daily care, and to record blood pressure, respiratory rate, pulse, fever and saturation parameters before the application. Since blood values are checked every day in the intensive care unit, no extra blood will be taken.

  six days

Study Arms (3)

Pomegranate seed oil

EXPERIMENTAL

In addition to the routine care of patients, pomegranate seed oil will be applied to the sacrum and heels twice a day between 09.00-21.00 without pressing. 1.5 cc will be applied to the back of the sacrum and 1 cc to each heel, using circular movements without pressure for approximately 5 seconds. It will be waited for 2-3 minutes for the body to absorb the oil, then it will be touched and removed with a napkin without any rubbing movements. The application will be applied for 6 days.

Other: topical pomegranate seed oil

Sesame oil

ACTIVE COMPARATOR

In addition to the routine care of patients, Sesame oil will be applied to the sacrum and heels twice a day between 09.00-21.00 without pressing. 1.5 cc will be applied to the back of the sacrum and 1 cc to each heel, using circular movements without pressure for approximately 5 seconds. It will be waited for 2-3 minutes for the body to absorb the oil, then it will be touched and removed with a napkin without any rubbing movements. The application will be applied for 6 days.

Other: Sesame oil

Control group

NO INTERVENTION

Patients will not be interfered with in their routine care. Patient monitoring will be done every afternoon for 6 days.

Interventions

topical pomegranate seed oil OTHER

Intervention groups: In addition to the routine care of the patients, Pomegranate seed oil will be applied to the sacrum and heels twice a day between 09.00-21.00 without pressing. 1.5 cc will be applied to the back of the sacrum and 1 cc to each heel, using circular movements without pressure for approximately 5 seconds. It will be waited for 2-3 minutes for the body to absorb the oil, then it will be touched and removed with a napkin without any rubbing movements. The application will be applied for 6 days. The patient follow-up form will be completed by the researcher every day at 12:00 noon. Again, on the 6th day of the application, evaluation surveys with the Braden risk assessment scale will be conducted by the researcher.

Pomegranate seed oil

Sesame oil OTHER

Sesame oil

Sesame oil

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Without skin disease
• Those within the first 24 hours of admission to the intensive care clinic,
• Those with medium, high and very high risk according to the Braden risk assessment scale
• Patients without malnutrition according to CONUT score
• Those with hemoglobin level of 8 and above
• Patients who will stay in intensive care for 6 days or more
• Those with a BMI of 35 and below
• Those whose oxygen saturation is 90 and above

You may not qualify if:

• Those who do not allow themselves or their first degree relatives to participate in the study,
• Those with pressure sores during hospitalization,
• Those with severe edema (+4 and above),
• Those with albumin 2 and below
• Those with prealbumin 10 and below,
• Those who have a known allergy to any skin care product,
• Patients with contraindications due to brain death, cardiac arrest, etc.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (2)

Handan Topan

Kayseri, 38039, Turkey (Türkiye)

Location

Handan

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Sesame Oil

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Pomegranate seed oil: Pomegranate seed oil will be applied to the sacrum and heels twice a day between 09.00-21.00 without pressing. This process will continue for six days. Sesame oil: Sesame oil will be applied to the sacrum and heels twice a day between 09.00-21.00 without pressing. This process will continue for six days.

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 30, 2023
• Study Start: February 18, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 15, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)