Clinical trial NCT06104540: Comparison of the Effects of Liquid Vaseline and Olive Oil on Itching and Scarring in Scald Burns
Official title: Comparison of the Effects of Liquid Vaseline and Olive Oil on Itching and Scarring in Scald Burns
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scald Burn
Itching
Hypertrophic Scarring
Keywords: scald burns
nursing care
oliveoil
liquid vaseline
itching
hypertrophic scarring
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A preliminary study will be conducted with 24 patients, 8 in the control group and 8 in the experimental group I olive oil and the experimental group II 8 with liquid vaseline. Patients will be divided into control and experimental groups by simple stratified randomization method.

In order to prevent the choice of treatment from being at the discretion of the investigator, it is necessary to ensure that the patients are randomly assigned to the study groups. The easiest method for this is simple randomization. The envelope drawing method will be used for randomization and patients who meet the research criteria will be stratified according to gender. To ensure gender stratification in the control and experimental groups, male patients will be assigned to control and experimental groups and female patients will be assigned to control and experimental groups.
Primary purpose: PREVENTION

Brief summary: Pain, itching, hypertrophic scar formation after wound healing in burn patients complications, sleep disturbances in patients, anxiety, depression, and daily life It may disrupt activities and deterioration in quality of life. Liquid petroleum jelly and olive oil have no side effects, moisturizing properties, or wound-healing treatment of burns due to their positive effects on symptoms such as itching. can be used to alleviate burns. The project found the use of liquid petroleum jelly and olive oil to determine the effect on itching and scarring in burn patients. After burns reduction of symptoms such as itching, dryness, hypertrophic scarring, and patient comfort. Provision of care is a part of nursing care. In studies, itching and scarring there is insufficient evidence regarding the treatment methods applied for its treatment is observed. In addition, the effect of olive oil and liquid petroleum jelly on itching and scarring no scientific study was found. The results of the project were found to be significant in terms of post-burn itching providing evidence of hypertrophic scar management and contributing to ongoing studies is expected to be found. Since there are no similar studies in the literature, a preliminary study with 24 patient applications will be made. In line with the data obtained from the pre-application, the sample calculation will be made and the application will continue by making the necessary arrangements. Patients will be divided into experimental and control groups by simple randomization. All patient groups individual data collection forms on the first day; 12 individual data collection forms on the first day, 15th day, first, second, and third months Itemized Itch Severity Scale, Patient and Observer Scar Scale to be applied in Burn Patients and the wound area will be photographed. Patients in the control group will be given no application will be made. Liquid petroleum jelly and olive oil group before the study training will be given and they will massage the recommended product twice a day for 3 months and will be asked to record them. The data obtained at the end of the project will be statistically analyzed and results will be presented.

Detailed description: In addition to localized damage, burn is defined as a comprehensive trauma that affects the whole organism and determines the prognosis with its physiological response and can cause physical, psychological, sociological, and economic problems in the individual. Although the etiology of burn injuries varies according to industrialization, socioeconomic, cultural, educational, and age groups, scald burns, flame burns, and electrical burns are the most common causes of burn injuries. Esen et al. (2021) reported that scald burns ranked first among the causes of burns with 37.2% in their study. Although survival in patients has increased with advances in burn treatment, wound healing, and understanding of scar pathophysiology, burns are still an important cause of morbidity. In these patients, postburn pruritus and hypertrophic scarring is a common and important complication that occurs during the wound-healing process Histamine produced by mast cells during the injury process plays a role in the development of post-burn itching and acute itching begins with wound closure. The prevalence of itching after burns is reported to be 80-100% The risk of itching increases in patients with large burn surface area, surgical procedures related to burn, hypertrophic scarring, female gender, dry skin, limb, and facial burns In addition to itching, patients may experience various sensory disturbances such as "pinprick", stabbing, or burning after burns.

Another problem affecting patients after burns is the development of hypertrophic scarring. Abnormal increase of collagen and glycoprotein and transepidermal water loss during the wound healing process can cause hypertrophic scarring or keloid. In wound healing, hypertrophic scarring occurs within four weeks after complete reepithelialization and regresses in approximately 15 months. The incidence of hypertrophic scar formation following burn injuries ranges from 34% to 94%. In one study, itching, pain, and paresthesia requiring treatment were observed in patients with hypertrophic scarring, and it is recommended to identify and prevent risk factors for treatment and symptom control.

Alleviation of itching symptoms after burns and early diagnosis of hypertrophic scar development is important in rehabilitation. Itching and hypertrophic scarring can cause cosmetic problems, severe functional disability, pain, sleep disorders, re-damage of fragile skin, and risk of infection with microorganism colonization, anxiety, and depression. Topical moisturizers, cold application, pressure garments, antihistamines, massage, psychological therapy and dermatological treatments, surgical techniques, and laser treatment can be applied in the treatment. The effectiveness of all these treatment methods is limited and there is insufficient evidence.

One of the factors that make scars visible is dry skin due to transepidermal water loss and skin should be kept moist to minimize the appearance of scars. The use of moisturizers has been identified as one of the components of treatment to reduce itching and hypertrophic scarring. Moisturizers are available in the form of plant extracts and various oils. Various topical products with moisturizing properties such as olive oil, and St. John's wort can be used in the treatment of burns and alleviation of itching and dryness symptoms after burns due to their cheap and easy availability, lack of side effects, moisturizing properties, positive properties on wound healing. Olive oil contains fatty components such as oleic acid, phenolic compounds, chlorophyll, and vitamin E. These components accelerate wound healing, moisturize the skin, and provide elasticity to the skin. In the study investigating the effect of olive oil and flaxseed on burn healing, it was shown that when the oils were applied as a mixture, they reduced inflammation and had a positive effect on wound size.

One of the products used for moisturizing is liquid petroleum jelly. Liquid petroleum jelly is obtained from liquid petroleum consisting of colorless, odorless, oily saturated hydrocarbons. It is widely used for cosmetic purposes and is included in the composition of many topical products. It reduces skin water loss, moisturizes the skin, reduces itching symptoms, acts as a barrier, and protects skin integrity. Wang et al. (2020) found that liquid petroleum jelly was more effective in wound healing and prevention of infection compared to normal saline in their research evaluating the effectiveness of liquid petroleum jelly in the treatment of burn wounds.

Problems such as itching, dryness, scarring, and hypertrophic scarring after burns negatively affect the patient's quality of life and body image. Therefore, the nurse should know the treatment and preventive measures and evaluate the effectiveness of the interventions using appropriate measurement tools. It is stated in the literature that the substances in the composition of olive oil support wound healing and moisturizing properties, but there are no clinical studies investigating the effect of olive oil and liquid petroleum jelly on itching and scarring in burn wounds. This study aims to determine the effect of topically applied olive oil and liquid petroleum jelly on itching and scarring in post-burn patients.

Expected benefits and risks of research, The study will be conducted to determine the effect of olive oil and liquid petroleum jelly on itching and scarring that occur during the healing period after a scald burn.

This study aims to help patients cope with itching and scarring problems that occur in the post-burn period and to shed light on the nursing interventions to be made for a more qualified life.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-65,
* With a total body burn area of less than 15% 2nd degree scald burn,
* Wwhose treatment has been completed and who do not need dressing and do not have open wounds,
* Who do not have any allergies,
* Who can read and write,
* Who do not have cognitive problems,
* Who do not have communication problems,
* Who live in Ankara and who volunteer to participate in the study.

Exclusion Criteria:

* Patients with burns on the face and neck,
* Ppatients with dermatologic diseases and patients using antihistamines will not be included.
* Patients who do not want to continue the study,
* Who develop an allergic reaction during the follow-up period,
* Who start treatment during the follow-up period due to itching,
* Wwho have not applied more than 20% liquid vaseline/olive oil during the 3-month follow-up period (60 applications/30 days; more than 36 applications out of 180 applications) will be excluded from the study.

Primary outcomes:
measure: 12-item itch scale scores
timeFrame: Before you start applying liquid vaseline
measure: Observer scar assesment scale score
timeFrame: Before you start applying liquid vaseline
measure: 12-item itch scale scores
timeFrame: Before you start applying extra virgin olive oil
measure: Patient scar assesment scale score
timeFrame: Before you start applying extra virgin olive oil
measure: Observer scar assesment scale score
timeFrame: Before you start applying extra virgin olive oil
measure: 12-item itch scale scores
timeFrame: will be applied to the control group on the first day
measure: Patient scar assessment scale score
timeFrame: will be applied to the control group on the first day
measure: Observer scar assesment scale score
timeFrame: will be applied to the control group on the first day
measure: Patient scar assesment scale score
timeFrame: Before you start applying liquid vaseline
Secondary outcomes:
measure: 12-item itch scale scores
timeFrame: 15 days after starting liquid vaseline application
measure: Patient scar assesment scale score
timeFrame: 15 days after starting liquid vaseline application
measure: Observer scar assesment scale score
timeFrame: 15 days after starting liquid vaseline application
measure: 12-item itch scale scores
timeFrame: 15 days after starting extra virgin olive oil
measure: Patient scar assesment scale score
timeFrame: 15 days after starting extra virgin olive oil
measure: Observer scar assessment scale score
timeFrame: 15 days after starting extra virgin olive oil
measure: 12-item itch scale scores
timeFrame: control group will be applied on the 15th day
measure: Patient scar assessment scale score
timeFrame: control group will be applied on the 15th day
measure: Observer scar assessment scale score
timeFrame: control group will be applied on the 15th day
Other outcomes:
measure: 12-item itch scale scores
timeFrame: One month after starting liquid vaseline application
measure: Patient scar assessment scale score
timeFrame: One month after starting liquid vaseline application
measure: Observer scar assessment scale score
timeFrame: One month after starting liquid vaseline application
measure: 12-item itch scale scores
timeFrame: One month after starting extra virgin olive oil application
measure: Patient scar assesment scale score
timeFrame: One month after starting extra virgin olive oil application
measure: Observer scar assesment scale score
timeFrame: One month after starting extra virgin olive oil
measure: 12-item itch scale scores
timeFrame: control group will be applied in the first month
measure: Patient scar assesment scale score
timeFrame: control group will be applied in the first month
measure: Observer scar assesment scale score
timeFrame: control group will be applied in the first month
measure: 12-item itch scale scores
timeFrame: Two month after starting liquid vaseline application
measure: Patient scar assesment scale score
timeFrame: Two month after starting liquid vaseline application
measure: Observer scar assesment scale score
timeFrame: Two month after starting liquid vaseline application
measure: 12-item itch scale scores
timeFrame: Two month after starting extra virgin olive oil application
measure: Patient scar assesment scale score
timeFrame: Two month after starting extra virgin olive oil application
measure: Observer scar assesment scale score
timeFrame: Two month after starting extra virgin olive oil application
measure: 12-item itch scale scores
timeFrame: The control group will be applied in the second month
measure: Patient scar assesment scale score
timeFrame: The control group will be applied in the second month
measure: Observer scar assesment scale score
timeFrame: The control group will be applied in the second month
measure: 12-item itch scale scores
timeFrame: Three month after starting liquid vaseline application
measure: Patient scar assesment scale score
timeFrame: Three month after starting liquid vaseline application
measure: Oobserver scar assesment scale score
timeFrame: Three month after starting liquid vaseline application
measure: 12-item itch scale scores
timeFrame: Three month after starting extra virgin olive oil application
measure: Patient scar assesment scale score
timeFrame: Three month after starting extra virgin olive oil application
measure: Observer scar assesment scale score
timeFrame: Three month after starting extra virgin olive oil application
measure: 12-item itch scale scores
timeFrame: The control group will be applied in the third month
measure: Patient scar assesment scale score
timeFrame: The control group will be applied in the third month
measure: Observer scar assesment scale score
timeFrame: The control group will be applied in the third month
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Merve AKIN, Ass Prof
role: PRINCIPAL_INVESTIGATOR
name: Nuray Çetintaş, Master
role: PRINCIPAL_INVESTIGATOR
name: Sema Koçaşlı, Prof Asst Dr
role: STUDY_DIRECTOR
References:
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