Wound Heal Clinical Trial
Official title:
Application of Plasma Activated Saline in Wound Treatment
This is a prospective, open-label, randomized, parallel controlled clinical trial. The purpose of this study is to understand the application value of plasma-activated normal saline in the treatment of different types of wounds. The main questions it aims to answer are: 1. What is the effect of plasma activated normal saline in promoting wound healing of different types? 2. What is the safety of plasma activated normal saline in the treatment of wound surface? Subjects will be randomly divided into the intervention group and the control group. The intervention group will receive wound treatment with plasma activated normal saline, and the control group will receive routine dressing change treatment.
Status | Not yet recruiting |
Enrollment | 162 |
Est. completion date | June 20, 2024 |
Est. primary completion date | June 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 1. Inclusion Criteria 1. Group of postoperative incision infection - Age =18 years old, =75 years old, gender unlimited. - Clinical diagnosis of postoperative incision infection. - Must be no significant risk of head trauma or closed injury to the chest and abdomen. - Fully understand the study content and subjects' rights and interests, and sign the informed consent. 2. Group of postoperative incision fat liquefaction - Age =18 years old, =75 years old, gender unlimited. - Clinical diagnosis of postoperative incision fat liquefaction. - Must be no incision infection or organ infection was involved in deep surgery, and no other serious complications occurred. - Must be no significant risk of head trauma or closed injury to the chest and abdomen. - Fully understand the study content and subjects' rights and interests, and sign the informed consent. 3. Group of infectious ulcers - Age =18 years old, =75 years old, gender unlimited. - Clinical diagnosis of superficial skin ulcer infection caused by various causes, which can have one or more wounds. - The formation time of the wound surface exceeds 1 month. - Fully understand the study content and subjects' rights and interests, and sign the informed consent. 2. Exclusion Criteria - Allergic to multiple drugs, dressings, gels or materials used in this study. - Functional injury of cardiopulmonary system, with obvious risk of craniocerebral trauma or severe closed injury of chest and abdomen. - Severe malnutrition, hypoproteinemia, moderate to severe anemia. - Pregnant or lactating women (lactating female subjects can still be included if they agree to stop breastfeeding during the treatment period and within one week after the last medication). - Patients with active wound bleeding, poor mental condition and critical condition. - Poor glycemic control of diabetes mellitus; Severe malnutrition, hypoproteinemia, moderate and severe anemia. - The presence of inflammatory skin diseases, such as atopic dermatitis or eczema, that affect efficacy and safety evaluation. - Poor glycemic control of diabetes mellitus; Severe malnutrition, severe cardiopulmonary disease, hypertension, widespread local necrosis requiring immediate toe amputation. - Combined with anaerobic bacteria infection, wet gangrene, abdominal infection, hematogenous infection, and intra-articular infection. - Ulcers caused by diabetic feet and malignant tumors. - History of glucocorticoid use and anticoagulant drug use within 12 months before enrollment. - History of immune disease or immunosuppressant use. - Poor compliance due to cognitive impairment or mental illness. - Any conditions that the investigator considered might increase the risk to the subject or affect the evaluation of efficacy. |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Xian JiaotongUniversity | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital Xi'an Jiaotong University |
China,
Bernhardt T, Semmler ML, Schafer M, Bekeschus S, Emmert S, Boeckmann L. Plasma Medicine: Applications of Cold Atmospheric Pressure Plasma in Dermatology. Oxid Med Cell Longev. 2019 Sep 3;2019:3873928. doi: 10.1155/2019/3873928. eCollection 2019. — View Citation
Brany D, Dvorska D, Halasova E, Skovierova H. Cold Atmospheric Plasma: A Powerful Tool for Modern Medicine. Int J Mol Sci. 2020 Apr 22;21(8):2932. doi: 10.3390/ijms21082932. — View Citation
Cheng B, Jiang Y, Fu X, Hao D, Liu H, Liu Y, Huang Z, Tan Q, Wang L, Hu D, Yang Y, Han C, Cheng Z, Ran X, Li Y. Epidemiological characteristics and clinical analyses of chronic cutaneous wounds of inpatients in China: Prevention and control. Wound Repair Regen. 2020 Sep;28(5):623-630. doi: 10.1111/wrr.12825. Epub 2020 Jun 25. — View Citation
Jang Y, Bok J, Ahn DK, Kim CK, Kang JS. Human Trial for the Effect of Plasma-Activated Water Spray on Vaginal Cleaning in Patients with Bacterial Vaginosis. Med Sci (Basel). 2022 Jun 18;10(2):33. doi: 10.3390/medsci10020033. — View Citation
Kadam S, Shai S, Shahane A, Kaushik KS. Recent Advances in Non-Conventional Antimicrobial Approaches for Chronic Wound Biofilms: Have We Found the 'Chink in the Armor'? Biomedicines. 2019 Apr 30;7(2):35. doi: 10.3390/biomedicines7020035. — View Citation
Kim S, Kim CH. Applications of Plasma-Activated Liquid in the Medical Field. Biomedicines. 2021 Nov 16;9(11):1700. doi: 10.3390/biomedicines9111700. — View Citation
Lee HR, Kang SU, Kim HJ, Ji EJ, Yun JH, Kim S, Jang JY, Shin YS, Kim CH. Liquid plasma as a treatment for cutaneous wound healing through regulation of redox metabolism. Cell Death Dis. 2023 Feb 13;14(2):119. doi: 10.1038/s41419-023-05610-9. — View Citation
Leren L, Johansen EA, Eide H, Sorum Falk R, Ljosa TM. Prevalence and factors associated with ulcer-related pain in persons with chronic leg ulcers-an explorative study. J Clin Nurs. 2021 Sep;30(17-18):2732-2741. doi: 10.1111/jocn.15787. Epub 2021 May 5. — View Citation
Liu HR, Yang P, Han S, Zhang Y, Zhu HY. The application of enhanced recovery after surgery and negative-pressure wound therapy in the perioperative period of elderly patients with colorectal cancer. BMC Surg. 2021 Sep 6;21(1):336. doi: 10.1186/s12893-021- — View Citation
Liu Z, Dumville JC, Norman G, Westby MJ, Blazeby J, McFarlane E, Welton NJ, O'Connor L, Cawthorne J, George RP, Crosbie EJ, Rithalia AD, Cheng HY. Intraoperative interventions for preventing surgical site infection: an overview of Cochrane Reviews. Cochra — View Citation
Mirhaj M, Labbaf S, Tavakoli M, Seifalian A. An Overview on the Recent Advances in the Treatment of Infected Wounds: Antibacterial Wound Dressings. Macromol Biosci. 2022 Jul;22(7):e2200014. doi: 10.1002/mabi.202200014. Epub 2022 Apr 28. — View Citation
Rezaei F, Vanraes P, Nikiforov A, Morent R, De Geyter N. Applications of Plasma-Liquid Systems: A Review. Materials (Basel). 2019 Aug 27;12(17):2751. doi: 10.3390/ma12172751. — View Citation
Seidel D, Diedrich S, Herrle F, Thielemann H, Marusch F, Schirren R, Talaulicar R, Gehrig T, Lehwald-Tywuschik N, Glanemann M, Bunse J, Huttemann M, Braumann C, Heizmann O, Miserez M, Kronert T, Gretschel S, Lefering R. Negative Pressure Wound Therapy vs — View Citation
Sen CK. Human Wound and Its Burden: Updated 2020 Compendium of Estimates. Adv Wound Care (New Rochelle). 2021 May;10(5):281-292. doi: 10.1089/wound.2021.0026. — View Citation
Smolkova B, Frtus A, Uzhytchak M, Lunova M, Kubinova S, Dejneka A, Lunov O. Critical Analysis of Non-Thermal Plasma-Driven Modulation of Immune Cells from Clinical Perspective. Int J Mol Sci. 2020 Aug 28;21(17):6226. doi: 10.3390/ijms21176226. — View Citation
Tanaka H, Bekeschus S, Yan D, Hori M, Keidar M, Laroussi M. Plasma-Treated Solutions (PTS) in Cancer Therapy. Cancers (Basel). 2021 Apr 6;13(7):1737. doi: 10.3390/cancers13071737. — View Citation
Xu D, Wang S, Li B, Qi M, Feng R, Li Q, Zhang H, Chen H, Kong MG. Effects of Plasma-Activated Water on Skin Wound Healing in Mice. Microorganisms. 2020 Jul 21;8(7):1091. doi: 10.3390/microorganisms8071091. — View Citation
Zhai S, Xu M, Li Q, Guo K, Chen H, Kong MG, Xia Y. Successful Treatment of Vitiligo with Cold Atmospheric Plasma-Activated Hydrogel. J Invest Dermatol. 2021 Nov;141(11):2710-2719.e6. doi: 10.1016/j.jid.2021.04.019. Epub 2021 May 21. — View Citation
Zhang J, Qu K, Zhang X, Wang B, Wang W, Bi J, Zhang S, Li Z, Kong MG, Liu D, Liu C. Discharge Plasma-Activated Saline Protects Against Abdominal Sepsis by Promoting Bacterial Clearance. Shock. 2019 Jul;52(1):92-101. doi: 10.1097/SHK.0000000000001232. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The trends in wound healing rate | Wound healing rate=Number of healing cases/total cases ×100% | 1 day up to 21 days | |
Secondary | The number of participants with wound effusion | Observe whether there is fluid, pus and other exudation on the wound and the number of days when the effusion disappeared will be recorded. | The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment | |
Secondary | The number of participants who tested positive for the etiology of wound exudates or extracts | Check whether there is bacterial infection and infected strains on the wound. | The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment. | |
Secondary | Wound pain score | Wound pain will be measured on the Visual Analogue Scale with a minimum score of 0 and a maximum score of 10 on the VAS, 0 indicating no pain at all, 10 indicating severe pain that is unbearable, and a higher score indicating more severe pain. | The indicators will be collected at day 1, 7, 14 and 21 after the start of treatment. | |
Secondary | The number of adverse event | In this trial, any adverse medical event occurring within 30 days after the subject's signing of the informed consent to the final dose, regardless of whether there is a causal relationship with the test drug, is considered to be an adverse event. Adverse events and descriptions of all associated symptoms, such as time of occurrence, severity, duration, action taken, final outcome and outcome, will be recorded. | These indicators will be collected at 1, 7, 14, and 21 days after starting treatment, and at 1 week and 1 month after ending treatment. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05023135 -
DeepView SnapShot Portable (DV-SSP): Device Training Study
|
||
Recruiting |
NCT03459547 -
Soft Peri-implant Tissue Around Different Abutment Materials
|
N/A | |
Recruiting |
NCT05608187 -
Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers
|
Phase 2 | |
Active, not recruiting |
NCT03649308 -
Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting
|
N/A | |
Recruiting |
NCT04596124 -
Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze
|
N/A | |
Completed |
NCT03285542 -
Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty
|
N/A | |
Recruiting |
NCT05474911 -
PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.
|
N/A | |
Recruiting |
NCT05689775 -
Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
|
||
Recruiting |
NCT04849143 -
The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation
|
N/A | |
Completed |
NCT03596112 -
The Difference in Wound Size Reduction Comparing Two Frequently Used Wound Dressings in Everyday Care
|
N/A | |
Recruiting |
NCT05169814 -
Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds
|
Early Phase 1 | |
Completed |
NCT04545476 -
Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities
|
N/A | |
Completed |
NCT06020157 -
Comparison of Simple and Continuous Suture Techniques in Oral Surgery
|
N/A | |
Recruiting |
NCT05133570 -
Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities
|
||
Recruiting |
NCT04901325 -
Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG)
|
Phase 2 | |
Withdrawn |
NCT03668665 -
Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in "Split Wound Design"
|
Phase 3 | |
Completed |
NCT03703479 -
Effect of A-PRF After Removal of Wisdom Teeth
|
N/A | |
Recruiting |
NCT03204851 -
Microlyte Dressing in the Management of Wounds
|
N/A | |
Recruiting |
NCT06117436 -
Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients
|
Phase 2/Phase 3 | |
Completed |
NCT05618912 -
Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment
|
N/A |