T89.03
Conditions
Interventions
Group 1: Standard wound treatment (wound control, wound cleaning / dressing change). Dressing change
control group
Group 2: Standard wound treatment with additional Plasma treatment in the wound. After cleansing, the plasma treatment with the ME therapy device Teion plasma is applied directly in the
Sponsors
Teion Medizinprodukte GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All Minimum age: 18 years Maximum age: No maximum age Other inclusion criteria: Age = 18 years (majority) and legal capacity - Wound for secondary wound healing after surgical intervention - Localisation: entire integument - Initial wound volume min. 2 cm3 - No exposed bone - No undermining, accessible for plasma treatment - Written informed consent from study participants. For female patients: Confirmed postmenopausal state (defined as amenorrhoea for at least 12 months) or for women of childbearing potential (WOCBP): Negative high sensitivity urine or serum pregnancy test prior to enrolment/randomisation and use of a highly effective contraceptive method (failure rate of less than 1%): - Combined (oestrogen and progestogen containing) hormonal contraception associated with ovulation inhibition (oral/intravaginal/ transdermal), or - Progestogen-only hormonal contraception, associated with ovulation inhibition (oral/injectable/implantable), or - intrauterine device, or - intrauterine hormone release system, or - bilateral tubal occlusion, or - vasectomised partner, or - heterosexual abstinence.
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding, pacemaker or defibrillator, light/sun allergy, systemic/chronic infectious diseases (HIV, hepatitis, etc.). ), relevant tumour disease,ongoing chemotherapy or radiation, severe endogenous or drug immunosuppression, alcohol or drug abuse, dialysis requirement, oxygen requirement, wound infection, profuse bleeding wound, patients unwilling to consent to the storage and disclosure of pseudonymised medical data for study purposes, persons deprived of liberty under an official order or court order or authorisation, Persons who are in a dependent relationship with the sponsor, the investigator or the trial site are excluded from participation in the study, participation in another clinical trial according to the Medical Devices Implementation Act (MPDG)/Medical Devices Regulation (MDR) at the time of this study, participation in a therapeutic study (wound healing).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative change in wound size in % after 4 weeks in relation to baseline to the initial size | — |
Secondary
| Measure | Time frame |
|---|---|
| Time until 100% granulation - Wound conditions (photographic evaluation, fibrin coatings/crusts etc.), - Wound swab week 1 and week 4 - Questionnaires (safety/tolerability, wound pain, Wound QoL for quality of life) | — |
Countries
Germany
Contacts
Public ContactMartina Meinke
Center of Experimental and Applied Cutaneous Physiology (CCP) Projektleitung Teilprojekt CCP
Outcome results
None listed