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RecruitingNCT06104540Updated Aug 2, 2024

Comparison of the Effects of Liquid Vaseline and Olive Oil on Itching and Scarring in Scald Burns

An interventional study of Experimental I liquid vaseline groups and Experimental II extra virgin olive oil groups in Scald Burn, Itching and Hypertrophic Scarring, sponsored by Ankara Yildirim Beyazıt University. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-02.

Sponsored by Ankara Yildirim Beyazıt University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Scald Burn
  • Itching
  • Hypertrophic Scarring

Keywords

  • scald burns
  • nursing care
  • oliveoil
  • liquid vaseline
  • itching
  • hypertrophic scarring
03

In context

Pruritus

490 studies on the registry are indexed under Pruritus; 93 are open to participants now.

This study's planned enrollment of 24 is below the median of 60 across 422 interventional studies indexed under Pruritus.

Browse Pruritus studies →

Lead sponsor

Ankara Yildirim Beyazıt University is the lead sponsor of 241 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Experimental I Liquid Vaseline

    Liquid vaseline will be applied to the Experimental I group twice a day according to the oil application protocol

    Other: Experimental I liquid vaseline groups

  • 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

    Other: Experimental II extra virgin olive oil groups

  • Experimental
    Control group

    No application will be made to the control group other than the institution's recommendations.

    Other: Control Croup

Interventions

  • OtherExperimental I liquid vaseline groups

    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.

  • OtherExperimental II extra virgin olive oil groups

    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.

  • OtherControl Croup

    No intervention will be made other than the recommendations of the institution's physicians and nurses.

06

What researchers measure

Primary outcomes

  1. 12-item itch scale scores

    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

  2. Observer scar assesment scale score

    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

  3. 12-item itch scale scores

    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

  4. Patient scar assesment scale score

    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

  5. Observer scar assesment scale score

    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

  6. 12-item itch scale scores

    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

  7. Patient scar assessment scale score

    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

  8. Observer scar assesment scale score

    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

  9. Patient scar assesment scale score

    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 liquid vaseline

Secondary outcomes

  1. 12-item itch scale scores

    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

  2. Patient scar assesment scale score

    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

  3. Observer scar assesment scale score

    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 liquid vaseline application

  4. 12-item itch scale scores

    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

  5. Patient scar assesment scale score

    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

  6. Observer scar assessment scale score

    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

  7. 12-item itch scale scores

    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

  8. Patient scar assessment scale score

    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

  9. Observer scar assessment scale score

    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

Other outcomes

  1. 12-item itch scale scores

    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

  2. Patient scar assessment scale score

    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

  3. Observer scar assessment scale score

    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

  4. 12-item itch scale scores

    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

  5. Patient scar assesment scale score

    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 application

  6. Observer scar assesment scale score

    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

  7. 12-item itch scale scores

    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

  8. Patient scar assesment scale score

    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

  9. Observer scar assesment scale score

    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: control group will be applied in the first month

  10. 12-item itch scale scores

    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

  11. Patient scar assesment scale score

    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

  12. Observer scar assesment scale score

    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

  13. 12-item itch scale scores

    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

  14. Patient scar assesment scale score

    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

  15. Observer scar assesment scale score

    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

  16. 12-item itch scale scores

    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

  17. Patient scar assesment scale score

    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

  18. Observer scar assesment scale score

    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

  19. 12-item itch scale scores

    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

  20. Patient scar assesment scale score

    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

  21. Oobserver scar assesment scale score

    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

  22. 12-item itch scale scores

    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

  23. Patient scar assesment scale score

    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

  24. Observer scar assesment scale score

    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

  25. 12-item itch scale scores

    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

  26. Patient scar assesment scale score

    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

  27. Observer scar assesment scale score

    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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 29719102 ↗
  • 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. PubMed 32340421 ↗
  • 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. PubMed 19888834 ↗
  • 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. PubMed 11466186 ↗
  • 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. PubMed 29098154 ↗
  • 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. PubMed 22210065 ↗
  • 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. PubMed 21979845 ↗
  • 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. PubMed 22665131 ↗
  • 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. PubMed 36409190 ↗
  • 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. PubMed 36818058 ↗
  • 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. PubMed 15253184 ↗
  • 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. PubMed 32485929 ↗
  • 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. PubMed 23079565 ↗

Individual participant data

Plan to share: No — It is planned to share all IPD datasets collected according to the results of the pre-implementation.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2024; primary completion for Jan 2025, 4 months later.

Of 85 non-industry interventional studies with no phase under Pruritus, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's planned 4 months is below that.

Counting every sponsor, half of 101 studies reached it within 7 months; a quarter within 3 and three quarters within 13.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2023
First posted
Oct 27, 2023
StartEst.
Sep 1, 2024
Primary completionEst.
Jan 31, 2025
CompletionEst.
Jan 31, 2025
Last update
Aug 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06104540
Responsible party
Nuray Çetintaş (Principal investigator, Ankara Yildirim Beyazıt University) — Principal investigator
First posted
Oct 27, 2023
Start date
Sep 1, 2024 (estimated)
Primary completion
Jan 31, 2025 (estimated)
Completion
Jan 31, 2025 (estimated)
Last update
Aug 2, 2024

Study contacts

Nuray Çetintaş
Contact
nuray-2111@hotmail.com
905462651755
Sema Koçaşlı, Prof Asst Dr
Contact
skocasli@yahoo.com.tr
90 533 524 56 02
Merve AKIN, Ass Prof
principal investigator · Ankara City Hospital Bilkent
Nuray Çetintaş, Master
principal investigator
Sema Koçaşlı, Prof Asst Dr
study director

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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