Scald BurnNCT06104540
Comparison of the Effects of Liquid Vaseline and Olive Oil on Itching and Scarring in Scald Burns
A study testing Experimental I liquid vaseline groups and Experimental II extra virgin olive oil groups in people with Scald Burn and Itching, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Scald Burn, Itching, Hypertrophic Scarring
- What is being tested?
- Experimental I liquid vaseline groups and Experimental II extra virgin olive oil groups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 31 Jan 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, 06800
Nuray Çetintaş, Master, 905462651755, nuray-2111@hotmail.com
Sema Koçaşlı, Prof. Assist, 90 533 524 56 02, skocasli@yahoo.com.tr
About this study
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.
- Conditions
- Scald Burn, Itching, Hypertrophic Scarring
- Being tested
- Experimental I liquid vaseline groups, Experimental II extra virgin olive oil groups, Control Croup
- Keywords
- scald burns, nursing care, oliveoil, liquid vaseline, itching, hypertrophic scarring
- Medical subject headings
- Pruritus, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental I liquid vaseline groupsOther
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 II extra virgin olive oil groupsOther
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.
Control CroupOther
No intervention will be made other than the recommendations of the institution's physicians and nurses.
| Study group | Role | What they receive |
|---|---|---|
| Experimental I Liquid Vaseline | Experimental | Liquid vaseline will be applied to the Experimental I group twice a day according to the oil application protocol Receives: Other: Experimental I liquid vaseline groups |
| Experimental II Extra Virgin Olive Oil | Experimental | Extra Virgin Olive Oil will be applied to the Experimental I group twice a day according to the oil application protocol Receives: Other: Experimental II extra virgin olive oil groups |
| Control group | Experimental | No application will be made to the control group other than the institution's recommendations. Receives: Other: Control Croup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before you start applying liquid vaseline
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.
Measured: Before you start applying liquid vaseline
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.
Measured: Before you start applying extra virgin olive oil
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.
Measured: Before you start applying extra virgin olive oil
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.
Measured: Before you start applying extra virgin olive oil
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
Measured: will be applied to the control group on the first day
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.
Measured: will be applied to the control group on the first day
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.
Measured: will be applied to the control group on the first day
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.
Measured: Before you start applying liquid vaseline
Secondary outcomes (9)
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.
Measured: 15 days after starting liquid vaseline application
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.
Measured: 15 days after starting liquid vaseline application
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.
Measured: 15 days after starting liquid vaseline application
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.
Measured: 15 days after starting extra virgin olive oil
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.
Measured: 15 days after starting extra virgin olive oil
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.
Measured: 15 days after starting extra virgin olive oil
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
Measured: control group will be applied on the 15th day
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.
Measured: control group will be applied on the 15th day
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.
Measured: control group will be applied on the 15th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Sep 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Scald BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A preliminary study will be conducted with 24 patients, 8 in the control group and 8 in the experimental group I olive oil and the experimental group II 8 with liquid vaseline. Patients will be divided into control and experimental groups by simple stratified randomization method. In order to prevent the choice of treatment from being at the discretion of the investigator, it is necessary to ensure that the patients are randomly assigned to the study groups. The easiest method for this is simple randomization. The envelope drawing method will be used for randomization and patients who meet the research criteria will be stratified according to gender. To ensure gender stratification in the control and experimental groups, male patients will be assigned to control and experimental groups and female patients will be assigned to control and experimental groups.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuray Çetintaş, Ankara Yildirim Beyazıt University
- Investigators
- Merve AKIN, Ass Prof, Principal investigator, Ankara City Hospital BilkentNuray Çetintaş, Master, Principal investigatorSema Koçaşlı, Prof Asst Dr, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104540
- Sponsor's protocol ID
- AYBUSBENURAYCETINTAS0000000001
- Status last verified
- Jul 2024
- First submitted
- 23 Oct 2023
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is planned to share all IPD datasets collected according to the results of the pre-implementation.
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 29719102Wang 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 32340421Vercelli 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 19888834Sharif 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 11466186Reich 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 29098154Parnell 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 22210065Nedelec 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 21979845Lewis 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 22665131Karakoc 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 36409190Ghanbari 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 36818058Draaijers 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 15253184Chung 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 32485929Carrougher 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