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

NCT06104540 | Recruiting

• 1 other identifier: AYBUSBENURAYCETINTAS0000000001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Scald Burn; Itching; Hypertrophic Scarring

Keywords

scald burns; nursing care; oliveoil; liquid vaseline; itching; hypertrophic scarring

Outcome Measures

Primary 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.

  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.

  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.

  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.

  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.

  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

  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.

  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.

  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.

  Before you start applying liquid vaseline

Secondary Outcomes (9)

• 12-item itch scale scores

  15 days after starting liquid vaseline application

• Patient scar assesment scale score

  15 days after starting liquid vaseline application

• Observer scar assesment scale score

  15 days after starting liquid vaseline application

• 12-item itch scale scores

  15 days after starting extra virgin olive oil

• Patient scar assesment scale score

  15 days after starting extra virgin olive oil

Other Outcomes (27)

• 12-item itch scale scores

  One month after starting liquid vaseline application

• Patient scar assessment scale score

  One month after starting liquid vaseline application

• Observer scar assessment scale score

  One month after starting liquid vaseline application

Study Arms (3)

Experimental I Liquid Vaseline

EXPERIMENTAL

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 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

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.

Other: Control Croup

Interventions

Experimental I liquid vaseline groups OTHER

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 I Liquid Vaseline

Experimental II extra virgin olive oil groups OTHER

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 II Extra Virgin Olive Oil

Control Croup OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Related Publications (13)

• 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.

  PMID: 29719102 BACKGROUND

• 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.

  PMID: 32340421 BACKGROUND

• 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.

  PMID: 19888834 BACKGROUND

• 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.

  PMID: 11466186 BACKGROUND

• 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.

  PMID: 29098154 BACKGROUND

• 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.

  PMID: 22210065 BACKGROUND

• 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.

  PMID: 21979845 BACKGROUND

• 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.

  PMID: 22665131 BACKGROUND

• 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.

  PMID: 36409190 BACKGROUND

• 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.

  PMID: 36818058 BACKGROUND

• 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.

  PMID: 15253184 BACKGROUND

• 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.

  PMID: 32485929 BACKGROUND

• 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.

  PMID: 23079565 BACKGROUND

Related Links

• scholar.google.com.tr

MeSH Terms

Conditions

Pruritus; Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cicatrix; Fibrosis; Pathologic Processes

Study Officials

• Merve AKIN, Ass Prof

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

• Nuray Çetintaş, Master

  PRINCIPAL INVESTIGATOR

• Sema Koçaşlı, Prof Asst Dr

  STUDY DIRECTOR

Central Study Contacts

Nuray Çetintaş

CONTACT

905462651755; nuray-2111@hotmail.com

Sema Koçaşlı, Prof Asst Dr

CONTACT

90 533 524 56 02; skocasli@yahoo.com.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: September 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)