Clinical trial NCT06334679: The Effect of Cold Gel Pack Application on Itching in Burn Patients in the Maturation Stage
Official title: The Effect of Cold Gel Pack Application on Itching in Burn Patients in the Maturation Stage: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burns
Pruritus
Keywords: Burn
İtch/Pruritus
Cold Application
Maturation
Cold Gel Pack
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a prospective interventional type two-group randomized controlled clinical study. Distribution according to the groups and layers to be assigned for each intervention; Group-1 (Experiment) was designed as clinical routine (liquid petroleum jelly) and cold gel pack, and Group-2 (Control) was designed as clinical routine (liquid petroleum jelly).
Primary purpose: SUPPORTIVE_CARE

Brief summary: Burn is a serious trauma that causes acute damage to the skin and subcutaneous tissues due to the effect of heat, electricity, radiation, physical, and chemical substances. It has been reported that the incidence of itching is high in burn patients during the maturation stage of wound healing. The literature suggests that in managing the symptom of itching, skin hydration support along with cold application methods can also be used. The integrity of the skin, the duration, frequency, characteristics, areas of itching, and identifying conditions that increase or decrease itching are important for managing itching. This study is planned to be conducted with a randomized controlled design to examine the effect of applying cold gel packs to burn areas of burn patients during the maturation stage on itching. This researcher's hypothesis is that burn patients who applied cold gel packs to burn areas during the maturation phase had lower itching severity (frequency, duration, intensity) than those who did not.

Detailed description: Patients will be assigned to one of two groups according to the block randomization list, given a sequence number according to the date and time of admission. In addition to the clinical routine application, cold gel pack application will be applied to the patients in Group 1, and the clinical routine application will continue for those in Group 2. To collect data, the Patient Diagnosis Form developed by the researcher in line with literature information, the Visual Analog Scale for Itching, the Bates-Jensen Wound Assessment Tool and the 12-Item Itching Severity Scale, whose validity and reliability analysis has been conducted, will be used. Calculation of the sample size of the study was made with the G.Power (v3.1.7) computer program. In the study of Joo et al., a total of 26 patient samples were used to represent the universe, assuming that the difference in two independent groups was considered statistically significant according to the itching degree averages of burn patients (α = 0.05 significance level and 95% power). During the research process, it was decided to include a total of 60 individuals in the sample, with 30 patients in Group-1 (Experiment) and 30 patients in Group-2 (Control), taking into account possible losses.

Eligibility criteria: Inclusion Criteria:

* Burn percentage is between 15-25% and 1st or 2nd degree burn areas are in the maturation phase (BatesJensen Wound Assessment Tool Scale score=1-13),
* Describing itching in burn wounds in the last 24 hours,
* Over 18 years of age,
* Literate,
* Oriented to person, place and time,
* Having no vision, speech or communication problems,
* Do not have any skin disease other than burns,
* Patients whose vital signs are within physiological limits (Pulse: 60-100/min, Temperature: average 37 degrees Celsius, respiration 12-16/min, Blood Pressure: average 120/80).

Exclusion Criteria:

* Cold sensitivity/allergy,
* Perineum, neck and inner wrist burn areas
* Hypertrophic scar area,
* Burn infection
* Raynaud's disease,
* Use of aspirin, anticoagulants, non-steriod anti-inflammatory drugs,
* Evitamin and vasoactive agent use,
* Peripheral vascular disease,
* Connective tissue disease,
* Diabetic neuropathy,
* Use of a medication that will cause itching,
* Patients participating in another study conducted at the clinic
* Applying medical treatment in addition to the clinical routine due to itching,
* Due to the fact that he was discharged in a shorter period of time than the average hospitalization day, the research process failure to complete,
* Failure to comply with the monitoring process and conditions of the research,
* It was determined as the person wanting to leave the study voluntarily.

Primary outcomes:
measure: Itching severity
timeFrame: The itching severity of the patients was measured with the "12-Item Itching Severity Scale"; Before the first application, it will be evaluated a total of 5 times over 4 days, on the morning of the next day of application.
measure: Itching grade
timeFrame: itching grade will be evaluated instantly with the Visual Analog Scale (VAS) 0 minutes before each application and 20 minutes immediately after the application.The scale will be evaluated for 4 days with repeated measurements twice a day before and after
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kartal Dr.Lütfi Kırdar City Hospital
Study officials:
References:
citation: Joo SY, Kim JB, Cho YS, Cho YS, Seo CH. Effect of cold pack therapy for management of burn scar pruritus: A pilot study. Burns. 2018 Jun;44(4):1005-1010. doi: 10.1016/j.burns.2018.01.011. Epub 2018 Feb 13.
citation: Stepien K, Reich A. The 12-Item Pruritus Severity Scale - Determining the Severity Bands. Front Med (Lausanne). 2020 Dec 17;7:614005. doi: 10.3389/fmed.2020.614005. eCollection 2020.
citation: 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.
citation: Stander S, Augustin M, Reich A, Blome C, Ebata T, Phan NQ, Szepietowski JC; International Forum for the Study of Itch Special Interest Group Scoring Itch in Clinical Trials. Pruritus assessment in clinical trials: consensus recommendations from the International Forum for the Study of Itch (IFSI) Special Interest Group Scoring Itch in Clinical Trials. Acta Derm Venereol. 2013 Sep 4;93(5):509-14. doi: 10.2340/00015555-1620.