Textbook of Good Clinical Practice in Cold Plasma Therapy

Preface
Contents
Contributors
I: Introduction
	1: From Leap Innovation to Integrated Medical Care
		1.1	 Introduction
		1.2	 To Diagnose Problem Pathologies
			1.2.1	 Chronic and Infected Wounds
			1.2.2	 Chronic Wounds, Not Infected
			1.2.3	 Acute Wounds at Risk of Infection and Worsening
			1.2.4	 Non-Healing Wounds by Other Reasons
			1.2.5	 Infected Skin
		1.3	 To Apply Clinical Plasma Research
			1.3.1	 Mode of Action
				1.3.1.1	 Chronic Wounds
				1.3.1.2	 Acute Wounds
			1.3.2	 Approved Medical Devices
			1.3.3	 Evidence-Based Medicine
		1.4	 To Identify Wounds at Risk
			1.4.1	 Normal Healing Capability of Acute Wounds
			1.4.2	 Wound Healing Capability and Age
			1.4.3	 Wound Healing Capability and Gender
			1.4.4	 Wound Healing Capability and Concomitant Steroid Therapy
			1.4.5	 Wound Healing Capability and Cancer
		1.5	 To Act in Concert with the Patient
		1.6	 To Evaluate Treatment
			1.6.1	 Chronic and Infected Wounds
			1.6.2	 Non-Healing Wounds, Not Infected
			1.6.3	 Acute Wounds at Risk of Infection and Worsening
			1.6.4	 Non-Healing Wounds by Other Reasons
			1.6.5	 Infected Skin
		1.7	 Conclusion
		References
II: Concept
	2: Cold Physical Plasma: A Short Introduction
		2.1	 Introduction
		2.2	 A Brief History of Cold Plasmas
		2.3	 How to Generate a Cold Plasma?
		2.4	 Principal Composition of a Cold Plasma
			2.4.1	 Radiation
			2.4.2	 Electrical Fields
			2.4.3	 Reactive Species
				2.4.3.1	 In the Gas Phase
				2.4.3.2	 In the Liquid Phase
				2.4.3.3	 In the Solid Phase
		2.5	 Applications of Cold Plasmas
		Conclusion
		Literature
			Further Reading
	3: How Does Cold Plasma Work in Medicine?
		3.1	 Introduction
		3.2	 Plasma Components and Source Concepts
		3.3	 How Does Cold Plasma Work in Medicine: Conclusions Drawn from in Vitro Studies
			3.3.1	 The Role of Plasma-Derived Electric Fields in Vitro
			3.3.2	 Role of Plasma-Derived Thermal Energy (Heat) in Vitro
			3.3.3	 Role of Plasma-Derived Ultraviolet Radiation In Vitro
			3.3.4	 Role of Plasma-Derived ROS in Vitro
		3.4	 How Does Cold Plasma Work in Medicine: Conclusions Drawn from in Vivo and Tissue-Based Studies
			3.4.1	 The Role of Plasma-Derived Electric Fields in Vivo
			3.4.2	 The Role of Plasma-Derived Thermal Energy (Heat) in Vivo
			3.4.3	 The Role of Plasma-Derived UV Radiation in Vivo
			3.4.4	 The Role of Plasma-Derived ROS in Vivo
		Conclusion
		References
			Suggested Reading
			Mechanisms of Physico-Chemical and Biomedical Mechanisms of Plasmas
			Principles of the Best-Characterized Medical Plasma Jet
			Preclinical and Clinical Effects of a Plasma Jet in Dermatology
	4: Landmarks to Differentiate Between Reliable and Questionable Devices for Application in Plasma Medicine
		4.1	 Introduction
		4.2	 General Classification of Devices for Plasma Medicine
		4.3	 Basic Characterization of CAP Devices
		4.4	 Approved CAP Devices
		4.5	 Questionable Plasma Devices
		Conclusion
		References
			Further Reading
	5: How Safe is Plasma Treatment in Clinical Applications?
		5.1	 Introduction
		5.2	 Fundamentals in Risk Management and Mitigation Strategies
		5.3	 National and International Consensus Statements on Safety Standards in Clinical Plasma Medicine
		5.4	 Technical Demands on Plasma Devices and Their Multi-Component Signatures as Potential Hazards
			5.4.1	 Electric Fields
			5.4.2	 Thermal Energy
			5.4.3	 Ultraviolet Radiation
			5.4.4	 Chemical Energy
		5.5	 Genotoxic and Mutagenic Risk Assessment of Plasma Utilization
			5.5.1	 Studies on the Potential Cytotoxicity, Genotoxicity, and Mutagenicity in Biomedical Plasma Applications in Vitro and in Ovo
			5.5.2	 Plasma-Derived ROS Therapies in Preclinical Studies
			5.5.3	 Clinical Plasma Devices, Their Risk Assessments, and Application in Clinical Trials
		5.6	 Perspectives, Challenges, Limitations, and Concluding Remarks
		References
			Suggested Reading
			Plasma Sources
			Plasma-Driven ROS Therapies
			Safety
			Standardization
III: The Patient’s View at Basic Clinical Principles
	6: The Patient’s View at Basic Clinical Principles
		6.1	 Introduction
		6.2	 General Aspects of Plasma Medicine
		6.3	 Selection of Patients
		6.4	 Choice of Plasma Device
		6.5	 Handling of Complications
		Conclusion
IV: Treatment Tailored to Indications
	7: Cold Plasma Treatment for Chronic Wounds
		7.1	 Introduction
		7.2	 Diagnosis
		Box 7.1 Classification of Wounds
		7.3	 Physiology and Pathology
			7.3.1	 Hemostasis and Inflammation
			7.3.2	 Re-epithelialization
			7.3.3	 Remodeling
		7.4	 Standard Treatment Principles
		7.5	 Treatment Rationale
		7.6	 Cold Plasma Therapy
			7.6.1	 Pre-Treatment Assessment
			7.6.2	 Timing
			7.6.3	 Diagnosis and Treatment Planning
			7.6.4	 Anesthesia
			7.6.5	 Post-Treatment Care
			7.6.6	 Handling of Complications
		Conclusion
		References
	8: Cold Plasma Treatment for Acute Wounds
		8.1	 Introduction
		8.2	 Diagnosis
		8.3	 Physiology and Pathology
		8.4	 Standard Treatment Principles
		8.5	 Treatment Rationale
		8.6	 Cold Plasma Therapy
			8.6.1	 Pre-Treatment Assessment
			8.6.2	 Timing
			8.6.3	 Diagnosis and Treatment Planning
			8.6.4	 Anesthesia
			8.6.5	 Post-Treatment Care
			8.6.6	 Handling of Complications
		8.7	 Conclusion
		References
	9: Plasma Treatment of the Diabetic Foot Syndrome
		9.1	 Introduction
		9.2	 Diagnosis
		9.3	 Physiology and Pathology
		9.4	 Standard Treatment Principles
		9.5	 Treatment Rationale
		9.6	 Cold Atmospheric Plasma Treatment
			9.6.1	 Pre-treatment Assessment
			9.6.2	 Timing
			9.6.3	 Diagnosis and Treatment Planning
			9.6.4	 Anesthesia
			9.6.5	 Post-Treatment Care
			9.6.6	 Handling of Complications
		Conclusion
		References
	10: Cold Plasma Palliative Treatment of Cancer
		10.1 Introduction
		10.2 Diagnosis
		10.3 Physiology and Pathology
			10.3.1	 Antimicrobial Effect
			10.3.2	 Anti-Cancer Effect
		10.4 Standard Treatment Principles
		10.5 Treatment Rationale
		10.6 Therapy
			10.6.1	 Identification of Suitable Patients
			10.6.2	 Informing the Patient
			10.6.3	 Obtain Written Consent
			10.6.4	 Treatment
		Conclusion
		References
	11: Cold Atmospheric Plasma Treatment and Surgical Site Infections
		11.1 Introduction
		11.2 Diagnosis and Role of Surgical Site Infection (SSI)
		11.3 Physiology and Pathology
		11.4 Standard Treatment Principles
		11.5 Treatment Rationale
		11.6 Cold Plasma Therapy
			11.6.1	 Case I
			11.6.2	 Case II/III
			11.6.3	 Case IV
			11.6.4	 Case V
			11.6.5	 Case VI
		Conclusion
		References
	12: Cold Plasma Treatment for an Artificial Fistula at Risk
		12.1 Introduction
		12.2 Diagnosis
		12.3 Standard Treatment Principles
		12.4 Treatment Rationale
		12.5 Cold Atmospheric Plasma (CAP) Therapy
			12.5.1	 Pretreatment Assessment
			12.5.2	 Timing
			12.5.3	 Diagnosis and Treatment Planning
				12.5.3.1	 Superficial Driveline Infection (DESTINE-Stage 1a/b and 2a/b)
				12.5.3.2	 Superficial Driveline Infection (DESTINE-Stage 3)
				12.5.3.3	 Superficial Driveline Infection (DESTINE-Stage 4)
				12.5.3.4	 Ascending Driveline Infection (DESTINE-Stage 5) with Surgical Proximal Relocation Using Operative CAP Implementation and Primary Wound Closure
				12.5.3.5	 Ascending Driveline Infection (DESTINE-Stage 5) with Abscess Formation Near Exit-Points and Effective Subsequent Revisions Leading to Preservation of the Driveline Exit-Points; Use of NPWT with Intermediate CAP Therapy and Secondary Wound Cl
				12.5.3.6	 Ascending Driveline Infection (DESTINE-Stage 5) with Effective Driveline Revision; Negative Pressure Wound Therapy); Intermediate CAP Application and Secondary Wound Closure
				12.5.3.7	 Severe, Secreting Ascending Pseudomonas Aeruginosa-Associated Driveline Infection with Surgical Plasma Therapy and Relocation of Driveline as Last Resort
			12.5.4	 Anesthesia
			12.5.5	 Posttreatment Care
			12.5.6	 Handling of Complications
		Conclusion
		References
	13: Cold Plasma Treatment and Aesthetic Medicine
		13.1 Introduction
		13.2 Diagnosis
			13.2.1	 Complications Associated with Aesthetic Surgery
			13.2.2	 Complications Associated with Minimally Invasive Aesthetic Medicine
			13.2.3	 Complications Caused by Beauty Treatment
			13.2.4	 Beauty Flaws and Blemishes
				13.2.4.1	 The Preserve of MTI Plasma Treatment
				13.2.4.2	 A Future Role for CAP Plasma Treatment?
		13.3 Physiology and Pathology
			13.3.1	 No Pathology
			13.3.2	 Risk of Pathology
			13.3.3	 Pathology
		13.4 Standard Treatment Principles
			13.4.1	 Integration of Nonmedical Specialists for Mutual Benefit
			13.4.2	 Increased Attention to Aesthetic Indications
			13.4.3	 Cross-Border Consideration of MTI Plasma Medicine
		13.5 Treatment Rationale
		13.6 Therapy
			13.6.1	 CAP Plasma Treatment
				13.6.1.1	 Identifying Individual Risk Factors for Complications
				13.6.1.2	 Informing the Patient
				13.6.1.3	 Obtain Written Consent
				13.6.1.4	 Treatment
			13.6.2	 MTI Plasma Treatment
				13.6.2.1	 Patient Selection and Consultation
				13.6.2.2	 Preparation
				13.6.2.3	 Treatment
				13.6.2.4	 Aftercare
		Conclusion
		References
	14: Cold Plasma Treatment for Dental Aesthetics
		14.1 Introduction
			14.1.1	 Elective Indication
			14.1.2	 Not-Ideal Plasma Devices
			14.1.3	 Competing with Conventional Methods
		14.2 Diagnosis
		14.3 Physiology and Pathology
		14.4 Standard Treatment Principles
		14.5 Treatment Rationale
		14.6 Cold Plasma Therapy
			14.6.1	 Pretreatment Assessment
				14.6.1.1	 Indication
				14.6.1.2	 Informing the Patient
				14.6.1.3	 Consent of Patient
			14.6.2	 Timing
			14.6.3	 Diagnosis and Treatment Planning
			14.6.4	 Anesthesia
			14.6.5	 Posttreatment Care
			14.6.6	 Handling of Complications
		Conclusion
		References
V: Devices
	15: Basic Principles and Future Developments in Cold Plasma Therapy
		15.1 Introduction
		15.2 Plasma as Fourth State of Matter
		15.3 History of Plasma Application in Medicine
		15.4 Basic Principles of CAP Generation
		15.5 New Fields for Medical Application of Cold Atmospheric Plasma Technology
			15.5.1	 Expanding Application of Present CAP Technologies to Further Medical Fields
				15.5.1.1	 CAP in Endoscopy
				15.5.1.2	 Dental Application
			15.5.2	 Trends, Opportunities, and Challenges for CAP Technologies in Medicine
				15.5.2.1	 Tracing Ambulant Treatment Conditions
				15.5.2.2	 Further Development of DIN SPEC 91315
			15.5.3	 Emerging Synergies to Nonmedical Topics
				15.5.3.1	 CAP in Clinical Hygiene
				15.5.3.2	 CAP Liquid Interaction for Agriculture
		15.6 How Can We Transfer the Ideas of the Future to the World of Today
		References
	16: kINPen® MED – The Precise Cold Plasma Jet
		16.1 Introduction
		16.2 About the Device
			16.2.1	 Basic Principles/Technology
			16.2.2	 General Parameter (Electrical/Mechanical/Physical/Chemical/Biological Characteristics)
			16.2.3	 Risk Assessment and Product Safety
		16.3 Indications
			16.3.1	 Use and Treatment Recommendations
			16.3.2	 Successful Examples
		16.4 Clinical Trials
		16.5 Outlook and Further Developments
		Conclusion
		References
	17: DBD-CAP PlasmaDerm® Flex and Dress
		17.1 Introduction
		17.2 About the Device
			17.2.1	 Basic Principles/Technology
				17.2.1.1	 PlasmaDerm® Vario, Flex and Cutan
				17.2.1.2	 PlasmaDerm® DRESS
			17.2.2	 General Parameters
			17.2.3	 Risk Assessment and Product Safety
			17.2.4	 Indications
			17.2.5	 Use and Treatment Recommendations
			17.2.6	 Successful Examples
		17.3 Clinical Trials
		17.4 Outlook and Further Developments
		17.5 Conclusion
		Literature
	18: SteriPlas® and PlasmaTact®
		18.1 Introduction
		18.2 About the Devices
			18.2.1	 Basic Principles
		18.3 General Parameter: Physical Disruption of Bacterial Cells
		18.4 Risk Assessment and Product Safety [28]
		18.5 Indications
			18.5.1	 Use and Treatment Recommendations
		18.6 Successful Examples
			18.6.1	 Diabetic Foot Ulcers [20]
				18.6.1.1	 Patient 1
				18.6.1.2	 Patient 2
				18.6.1.3	 Patient 3
			18.6.2	 Surgical Site Infections [24]
		18.7 Results
			18.7.1	 Patient 1
			18.7.2	 Patient 2
			18.7.3	 Patient 3
			18.7.4	 Patient 4
			18.7.5	 Patient 5
			Conclusion
			18.7.6	 Dermatology [29]
				18.7.6.1	 Introduction
				18.7.6.2	 Objective
				18.7.6.3	 Materials and Methods
				18.7.6.4	 Results
		Conclusions
		18.8 Clinical Trials
		18.9 Outlook and Further Developments
		Conclusion
		References
	19: Plasma Care®
		19.1 Introduction
		19.2 About the Device
			19.2.1	 Basic Principles/Technology
			19.2.2	 General Parameter
				19.2.2.1	 Mechanical Parameter
				19.2.2.2	 Physicochemical Parameters
				19.2.2.3	 Biological Characteristics
			19.2.3	 Risk Assessment and Product Safety
		19.3 Indications
			19.3.1	 Use and Treatment Recommendations
			19.3.2	 Successful Examples
		19.4 Clinical Trials
		19.5 Outlook and Further Developments
		References/Further Reading/Additional Resources
VI: Organization
	20: Who Belongs to a Good Cold Plasma Practice Team?
		20.1 Introduction
		20.2 Requirements for a Basic Plasma Team
		20.3 Requirements for a Comprehensive Plasma Team
		Conclusion
		References
	21: How to Assure Good Clinical Practice in Plasma Therapy?
		21.1 Introduction
		21.2 Study Courses
			21.2.1	 Postgraduate M.Sc. “Plasma and Aesthetic Laser Medicine – PALM”
				21.2.1.1	 Target Group
				21.2.1.2	 Aims of Qualification
				21.2.1.3	 Curriculum
				21.2.1.4	 Examination
				21.2.1.5	 Degree
				21.2.1.6	 Tuition Fees and Study Service
			21.2.2	 Postgraduate Education in Clinical Plasma Medicine for Doctors
				21.2.2.1	 Target Group
				21.2.2.2	 Aims of Qualification
				21.2.2.3	 Curriculum
				21.2.2.4	 Examination
				21.2.2.5	 Diploma
				21.2.2.6	 Tuition Fees and Study Service
			21.2.3	 Postgraduate Education in Clinical Plasma Medicine for Natural Scientists and Engineers
				21.2.3.1	 Target Group
				21.2.3.2	 Aims of Qualification
				21.2.3.3	 Curriculum
				Box 21.1 Module 5 is one of the 6 of the complete Master of Science study program to demonstrate the pattern of teaching events, and it is the main module of the focused plasma medicine courses, common to all degree programs. The box explains th
				21.2.3.4	 Examination
				21.2.3.5	 Diploma
				21.2.3.6	 Tuition Fees and Study Service
			21.2.4	 Professional Continuous Training in Clinical Plasma Medicine for Nurses
				21.2.4.1	 Target Group
				21.2.4.2	 Aims of Training
				21.2.4.3	 Professional Training
				21.2.4.4	 Examination
				21.2.4.5	 Certificate
				21.2.4.6	 Tuition Fees
				21.2.4.7	 Study Counseling
		21.3 Conclusion
		References
			Suggested Reading
	22: What Are the Requirements of a Cold Plasma Medicine Clinic
		22.1 Introduction
		22.2 Requirements of a Plasma Medicine Clinic
		22.3 Requirements of a Comprehensive Plasma Medicine Clinic: Research
		22.4 Requirements of a Comprehensive Plasma Medicine Clinic: Teaching
		22.5 Requirements of a Comprehensive Plasma Medicine Clinic: Entrepreneurship
		22.6 Conclusion
		References
Index