Burns Clinical Trial
Official title:
The Effect of Cold Gel Pack Application on Itching in Burn Patients in the Maturation Stage: A Randomized Controlled Study
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 15, 2024 |
Est. primary completion date | November 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Kartal Dr.Lütfi Kirdar City Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Marmara University |
Turkey,
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. — View 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. — View 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 Intern — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Itching severity | The scale consists of 12 questions. Questions 2, 3, 4, 5, 6, 7, 8 and 12 in the scale have two options, "yes" and "no", and the scoring changes as 1 or 0. The frequency of itching in the first question and itchy areas in the 11th question are marked and scored between 1 and 3. The 9th question, which evaluates the frequency of waking up from sleep due to itching, has 4 items and is scored between 0-3. The 10th question, which evaluates the severity of itching, has 5 items and is scored between 1-5. The score obtained from the scale is at least 3 and at most 22, and as the score increases, the level of being affected by itching also increases. Scores obtained as a result of the scale indicate mild itching between "3-6", moderate itching between "7-11" and severe itching between "12-22". | 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. | |
Primary | Itching grade | Visual Analog Scale (VAS).It is stated that Visual Analogue Scale (VAS) can be used to measure the severity of itching. VAS is a numerical and one-dimensional scale and is mostly used to obtain an objective result by evaluating the intensity and severity of itching. The scale is scored between 1-10. VAS is a scale that initially ranges from 0 "I have no itching" to 10 "I have very severe itching", with each interval corresponding to one centimeter and given a numerical value. On the scale, 0 points indicate no itching, 1-3 points indicate mild itching, 4-6 points indicate moderate itching, 7-8 points indicate severe itching, and 9 and above points indicate very severe itching. | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05023135 -
DeepView SnapShot Portable (DV-SSP): Device Training Study
|
||
Completed |
NCT05276869 -
Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns
|
||
Completed |
NCT04548635 -
VR for Burn Dressing Changes at Home
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT06076031 -
Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing
|
N/A | |
Recruiting |
NCT05084248 -
Vitamin D Deficiency in Adults Following a Major Burn Injury
|
Phase 4 | |
Completed |
NCT03113253 -
TRANexamic Acid to Reduce Bleeding in BURN Surgery
|
Phase 4 | |
Recruiting |
NCT04090424 -
Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns
|
N/A | |
Not yet recruiting |
NCT05649891 -
Checklists Resuscitation Emergency Department
|
N/A | |
Withdrawn |
NCT03159182 -
Study of Silicone Material Inserts To Treat Burn Scars
|
N/A | |
Recruiting |
NCT02904941 -
Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns
|
N/A | |
Completed |
NCT02681757 -
Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns
|
N/A | |
Recruiting |
NCT01812941 -
Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
|
N/A | |
Completed |
NCT01437852 -
StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns
|
Phase 1 | |
Completed |
NCT01214811 -
Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing
|
Phase 3 | |
Completed |
NCT01061502 -
Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds
|
Phase 1/Phase 2 | |
Terminated |
NCT00822796 -
Thermogard™ Efficacy Trial
|
N/A | |
Terminated |
NCT00824681 -
Effect of Music Therapy on Families of Burn Patients
|
Phase 1 | |
Terminated |
NCT00634166 -
Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group
|
Phase 4 | |
Terminated |
NCT00464386 -
Continuous Glucose Monitoring (POC) in the ICU
|
N/A | |
Withdrawn |
NCT00216983 -
Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding
|
N/A |