- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06104540
Comparison of the Effects of Liquid Vaseline and Olive Oil on Itching and Scarring in Scald Burns
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nuray Çetintaş
- Phone Number: 905462651755
- Email: nuray-2111@hotmail.com
Study Contact Backup
- Name: Sema Koçaşlı, Prof Asst Dr
- Phone Number: 90 533 524 56 02
- Email: skocasli@yahoo.com.tr
Study Locations
-
-
-
Ankara, Turkey, 06800
- Recruiting
- Ankara Bilkent City Hospital
-
Contact:
- Nuray Çetintaş, Master
- Phone Number: 905462651755
- Email: nuray-2111@hotmail.com
-
Contact:
- Sema Koçaşlı, Prof. Assist
- Phone Number: 90 533 524 56 02
- Email: skocasli@yahoo.com.tr
-
Sub-Investigator:
- Merve Akın, Prof Ass.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental I Liquid Vaseline
Liquid vaseline will be applied to the Experimental I group twice a day according to the oil application protocol
|
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.
|
|
Experimental: Experimental II Extra Virgin Olive Oil
Extra Virgin Olive Oil will be applied to the Experimental I group twice a day according to the oil application protocol
|
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.
|
|
Experimental: Control group
No application will be made to the control group other than the institution's recommendations.
|
No intervention will be made other than the recommendations of the institution's physicians and nurses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
12-item itch scale scores
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. |
Before you start applying liquid vaseline
|
|
Observer scar assesment scale score
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. |
Before you start applying liquid vaseline
|
|
12-item itch scale scores
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. |
Before you start applying extra virgin olive oil
|
|
Patient scar assesment scale score
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. |
Before you start applying extra virgin olive oil
|
|
Observer scar assesment scale score
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. |
Before you start applying extra virgin olive oil
|
|
12-item itch scale scores
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 |
will be applied to the control group on the first day
|
|
Patient scar assessment scale score
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.
|
will be applied to the control group on the first day
|
|
Observer scar assesment scale score
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. |
will be applied to the control group on the first day
|
|
Patient scar assesment scale score
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. |
Before you start applying liquid vaseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
12-item itch scale scores
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. |
15 days after starting liquid vaseline application
|
|
Patient scar assesment scale score
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.
|
15 days after starting liquid vaseline application
|
|
Observer scar assesment scale score
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. |
15 days after starting liquid vaseline application
|
|
12-item itch scale scores
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. |
15 days after starting extra virgin olive oil
|
|
Patient scar assesment scale score
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.
|
15 days after starting extra virgin olive oil
|
|
Observer scar assessment scale score
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. |
15 days after starting extra virgin olive oil
|
|
12-item itch scale scores
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 |
control group will be applied on the 15th day
|
|
Patient scar assessment scale score
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.
|
control group will be applied on the 15th day
|
|
Observer scar assessment scale score
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. |
control group will be applied on the 15th day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
12-item itch scale scores
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. |
One month after starting liquid vaseline application
|
|
Patient scar assessment scale score
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.
|
One month after starting liquid vaseline application
|
|
Observer scar assessment scale score
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. |
One month after starting liquid vaseline application
|
|
12-item itch scale scores
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. |
One month after starting extra virgin olive oil application
|
|
Patient scar assesment scale score
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. |
One month after starting extra virgin olive oil application
|
|
Observer scar assesment scale score
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. |
One month after starting extra virgin olive oil
|
|
12-item itch scale scores
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. |
control group will be applied in the first month
|
|
Patient scar assesment scale score
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.
|
control group will be applied in the first month
|
|
Observer scar assesment scale score
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. |
control group will be applied in the first month
|
|
12-item itch scale scores
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. |
Two month after starting liquid vaseline application
|
|
Patient scar assesment scale score
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. |
Two month after starting liquid vaseline application
|
|
Observer scar assesment scale score
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. |
Two month after starting liquid vaseline application
|
|
12-item itch scale scores
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. |
Two month after starting extra virgin olive oil application
|
|
Patient scar assesment scale score
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.
|
Two month after starting extra virgin olive oil application
|
|
Observer scar assesment scale score
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. |
Two month after starting extra virgin olive oil application
|
|
12-item itch scale scores
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. |
The control group will be applied in the second month
|
|
Patient scar assesment scale score
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. |
The control group will be applied in the second month
|
|
Observer scar assesment scale score
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. |
The control group will be applied in the second month
|
|
12-item itch scale scores
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. |
Three month after starting liquid vaseline application
|
|
Patient scar assesment scale score
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.
|
Three month after starting liquid vaseline application
|
|
Oobserver scar assesment scale score
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. |
Three month after starting liquid vaseline application
|
|
12-item itch scale scores
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. |
Three month after starting extra virgin olive oil application
|
|
Patient scar assesment scale score
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.
|
Three month after starting extra virgin olive oil application
|
|
Observer scar assesment scale score
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. |
Three month after starting extra virgin olive oil application
|
|
12-item itch scale scores
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. |
The control group will be applied in the third month
|
|
Patient scar assesment scale score
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.
|
The control group will be applied in the third month
|
|
Observer scar assesment scale score
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. |
The control group will be applied in the third month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Merve AKIN, Ass Prof, Ankara Bilkent City Hospital
- Principal Investigator: Nuray Çetintaş, Master
- Study Director: Sema Koçaşlı, Prof Asst Dr
Publications and helpful links
General Publications
- Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
- Xiao Y, Sun Y, Zhu B, Wang K, Liang P, Liu W, Fu J, Zheng S, Xiao S, Xia Z. Risk factors for hypertrophic burn scar pain, pruritus, and paresthesia development. Wound Repair Regen. 2018 Mar;26(2):172-181. doi: 10.1111/wrr.12637.
- Wang JJ, Yang L, Chen X. [Observation on the effect of liquid paraffin as adjuvant therapy in treating residual wounds of patients with severe burns]. Zhonghua Shao Shang Za Zhi. 2020 Apr 20;36(4):304-307. doi: 10.3760/cma.j.cn501120-20190316-00122. Chinese.
- Vercelli S, Ferriero G, Sartorio F, Stissi V, Franchignoni F. How to assess postsurgical scars: a review of outcome measures. Disabil Rehabil. 2009;31(25):2055-63. doi: 10.3109/09638280902874196.
- Sharif F, Crushell E, O'Driscoll K, Bourke B. Liquid paraffin: a reappraisal of its role in the treatment of constipation. Arch Dis Child. 2001 Aug;85(2):121-4. doi: 10.1136/adc.85.2.121. No abstract available.
- Reich A, Bozek A, Janiszewska K, Szepietowski JC. 12-Item Pruritus Severity Scale: Development and Validation of New Itch Severity Questionnaire. Biomed Res Int. 2017;2017:3896423. doi: 10.1155/2017/3896423. Epub 2017 Oct 2.
- Parnell LK, Nedelec B, Rachelska G, LaSalle L. Assessment of pruritus characteristics and impact on burn survivors. J Burn Care Res. 2012 May-Jun;33(3):407-18. doi: 10.1097/BCR.0b013e318239d206.
- Nedelec B, Rachelska G, Parnell LK, LaSalle L. Double-blind, randomized, pilot study assessing the resolution of postburn pruritus. J Burn Care Res. 2012 May-Jun;33(3):398-406. doi: 10.1097/BCR.0b013e318233592e.
- Lewis PA, Wright K, Webster A, Steer M, Rudd M, Doubrovsky A, Gardner G. A randomized controlled pilot study comparing aqueous cream with a beeswax and herbal oil cream in the provision of relief from postburn pruritus. J Burn Care Res. 2012 Jul-Aug;33(4):e195-200. doi: 10.1097/BCR.0b013e31825042e2.
- Karakoc IB, Ekici B. Maintaining Skin Integrity in Neonates with Sunflower Seed Oil and Liquid Vaseline: A Prospective Randomized Controlled Study. Adv Skin Wound Care. 2022 Dec 1;35(12):1-8. doi: 10.1097/01.ASW.0000891080.13305.75.
- Ghanbari A, Masoumi S, Kazemnezhad Leyli E, Mahdavi-Roshan M, Mobayen M. Effects of Flaxseed Oil and Olive Oil on Markers of Inflammation and Wound Healing in Burn Patients: A Randomized Clinical Trial. Bull Emerg Trauma. 2023;11(1):32-40. doi: 10.30476/BEAT.2022.97070.1399.
- Chung BY, Kim HB, Jung MJ, Kang SY, Kwak IS, Park CW, Kim HO. Post-Burn Pruritus. Int J Mol Sci. 2020 May 29;21(11):3880. doi: 10.3390/ijms21113880.
- Carrougher GJ, Martinez EM, McMullen KS, Fauerbach JA, Holavanahalli RK, Herndon DN, Wiechman SA, Engrav LH, Gibran NS. Pruritus in adult burn survivors: postburn prevalence and risk factors associated with increased intensity. J Burn Care Res. 2013 Jan-Feb;34(1):94-101. doi: 10.1097/BCR.0b013e3182644c25.
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Study Start (Estimated)
Primary Completion (Estimated)
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First Submitted That Met QC Criteria
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- AYBUSBENURAYCETINTAS0000000001
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Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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