Ankara Bilkent City Hospital
Ankara, 06800, Turkey (Türkiye)
Location status: Recruiting
Location contact
Merve Akın, Prof Ass.
SUB_INVESTIGATOR
Nuray Çetintaş, Master
CONTACT
Sema Koçaşlı, Prof. Assist
CONTACT
NCT Number: NCT06104540
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Ankara, 06800, Turkey (Türkiye)
Location status: Recruiting
Merve Akın, Prof Ass.
SUB_INVESTIGATOR
Nuray Çetintaş, Master
CONTACT
Sema Koçaşlı, Prof. Assist
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in the liquid vaseline group will apply liquid vaseline twice a day for 3 months. Depending on the size of the burn area, 5-10 ml of liquid petroleum jelly will be applied to the burn area by massaging for 5 minutes twice a day, and each application will be recorded in the application follow-up form. Patients will be visited on the 15th day, first month, second month, and third month after the application begins.
Patients in the extra virgin olive oil group will apply extra virgin olive oil twice a day for 3 months. Depending on the size of the burn area, 5-10 ml of liquid petroleum jelly will be applied to the burn area by massaging for 5 minutes twice a day, and each application will be recorded in the application follow-up form. Patients will be visited on the 15th day, first month, second month, and third month after the application begins.
No intervention will be made other than the recommendations of the institution's physicians and nurses.
Time frame: Before you start applying liquid vaseline
assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases.
Time frame: Before you start applying liquid vaseline
assessment of hypertrophic scar.Observer Scar Assessment Scale, Each item is scored on a Likert-type scale between 1 and 10. has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable.
Time frame: Before you start applying extra virgin olive oil
assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases.
Time frame: Before you start applying extra virgin olive oil
assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar".
shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated.
Time frame: Before you start applying extra virgin olive oil
assessment of hypertrophic scar. Observer Scar Assessment Scale, Each item is scored on a Likert-type scale between 1 and 10. has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable.
Time frame: will be applied to the control group on the first day
assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases.
Assessment Scale, scar evaluation (vascularization, pigmentation, thickness, irregularity, elasticity, surface area) and scar A total of 7 articles, including 1 article evaluating the general opinion about is formed. Each item is scored on a Likert-type scale between 1 and 10. has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin, and the highest score is 60.
It represents the worst scar imaginable, and the scale score is based on the first 6 items.
was being calculated
Time frame: will be applied to the control group on the first day
assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated.
Time frame: will be applied to the control group on the first day
assessment of hypertrophic scar. Observer Scar Assessment Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin, and the highest score is 60.
It represents the worst scar imaginable.
Time frame: Before you start applying liquid vaseline
assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar".
shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated.
Time frame: 15 days after starting liquid vaseline application
assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases.
Time frame: 15 days after starting liquid vaseline application
assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated.
Time frame: 15 days after starting liquid vaseline application
assessment of hypertrophic scar. Observer Scar Assessment Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable.
Time frame: 15 days after starting extra virgin olive oil
assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases.
Time frame: 15 days after starting extra virgin olive oil
assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated.
Time frame: 15 days after starting extra virgin olive oil
assessment of hypertrophic scar. Observer Scar Assessment Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable.
Time frame: control group will be applied on the 15th day
assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases
Time frame: control group will be applied on the 15th day
assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated.
Time frame: control group will be applied on the 15th day
assessment of hypertrophic scar. Observer Scar Assessment Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable.
Time frame: One month after starting liquid vaseline application
assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases.
Time frame: One month after starting liquid vaseline application
assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated.
Time frame: One month after starting liquid vaseline application
assessment of hypertrophic scar. Observer Scar Assessment Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable.
Time frame: One month after starting extra virgin olive oil application
assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases.
Time frame: One month after starting extra virgin olive oil application
assessment of hypertrophic scar. Patient scar assessment scale,1 being "normal skin", 10 being "worst scar".
shows the evaluation. The lowest score a patient can get from the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. General opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated.
Time frame: One month after starting extra virgin olive oil
assessment of hypertrophic scar. Observer Scar Assessment Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable.
Time frame: control group will be applied in the first month
assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases.
Time frame: control group will be applied in the first month
assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated.
Time frame: control group will be applied in the first month
assessment of hypertrophic scar. Observer Scar Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable.
Time frame: Two month after starting liquid vaseline application
assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases.
Time frame: Two month after starting liquid vaseline application
assessment of hypertrophic scar. Patient scar assessment scale,1 being "normal skin", and 10 being "worst scar".
shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated.
Time frame: Two month after starting liquid vaseline application
assessment of hypertrophic scar. Observer Scar Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable.
Time frame: Two month after starting extra virgin olive oil application
assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases.
Time frame: Two month after starting extra virgin olive oil application
assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated.
Time frame: Two month after starting extra virgin olive oil application
assessment of hypertrophic scar. Observer Scar Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable.
Time frame: The control group will be applied in the second month
assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases.
Time frame: The control group will be applied in the second month
assessment of hypertrophic scar. Patient scar assessment scale, 1 being "normal skin", and 10 being "worst scar".
shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated.
Time frame: The control group will be applied in the second month
assessment of hypertrophic scar. Observer Scar Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable.
Time frame: Three month after starting liquid vaseline application
assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases.
Time frame: Three month after starting liquid vaseline application
assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get from the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. General opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated.
Time frame: Three month after starting liquid vaseline application
assessment of hypertrophic scar. Observer Scar Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable.
Time frame: Three month after starting extra virgin olive oil application
assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases.
Time frame: Three month after starting extra virgin olive oil application
assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get from the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. General opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated.
Time frame: Three month after starting extra virgin olive oil application
assessment of hypertrophic scar. Observer Scar Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable.
Time frame: The control group will be applied in the third month
assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases.
Time frame: The control group will be applied in the third month
assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated.
Time frame: The control group will be applied in the third month
assessment of hypertrophic scar. Observer Scar Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable.
Contact information is provided by the study sponsor or research team.
Nuray Çetintaş
CONTACT
Sema Koçaşlı, Prof Asst Dr
CONTACT
Ankara Yildirim Beyazıt University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07213544
Burn Scar, Cicatrix
Charleston, South Carolina, United States
View Trial DetailsNCT06704698
Behavior, Cold
Hangzhou, Zhejiang, China
View Trial DetailsNCT07395882
Itching, Pathological Conditions, Signs and Symptoms
Aalborg, Denmark
View Trial DetailsNCT07196358
Cicatrix, Cicatrix, Hypertrophic
Karachi, Sindh, Pakistan
View Trial Details