Cold Atmospheric Plasma, Peripheral Occlusive Disease, Prevention, Wound Healing, Wound Healing Complication
Conditions
Keywords
cold atmospheric plasma, prevention, wound healing disorder, vascular surgery, peripheral occlusive disease
Brief summary
The goal of this clinical trial is to learn if postoperative wound complications in the inguinal region of high-risk patients with peripheral arterial occlusive disease can be prevented by the intraoperative application of cold atmospheric plasma. The main questions it aims to answer are: Does the intraoperative application of cold atmospheric plasma reduce the need for surgical revision of inguinal wounds due to wound healing complications within 3 months postoperatively? Does the intraoperative application of cold atmospheric plasma reduce wound healing complications not requiring revision within 3 months postoperatively? Researchers will compare the application of cold atmospheric plasma to a placebo (a deactivated look-alike device). Participants will: Undergo surgical treatment with femoral artery access due to their peripheral arterial occlusive disease, in accordance with the respective vascular surgery department standard of care. Receive a single application of cold atmospheric plasma or, respectively, placebo in the area of their inguinal access wound during surgery (after subcutaneous closure and prior to skin closure). Be regularly assessed for wound healing during the first postoperative 14 days as part of routine clinical care and undergo a final evaluation at 3 months. They will also be surveyed regarding their quality of life.
Interventions
DEVICECold atmospheric plasma
Single intraoperative treatment of the wound edges and the subcutaneous tissue adjacent to the wound edges with cold atmospheric plasma after subcutaneous closure and prior to skin closure
DEVICESham device
Single intraoperative treatment of the wound edges and the subcutaneous tissue adjacent to the wound edges with sham device after subcutaneous closure and prior to skin closure
Sponsors
Ursula Werra
neoplas med GmbH
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Written informed consent * Surgical treatment of peripheral arterial occlusive disease (PAOD) with femoral (inguinal) access * High-risk patient for wound healing complications: WHD (wound healing disorder) score ≥ 4 points: Diabetes mellitus (2) Immunosuppression/steroid therapy (2) End-stage renal disease (2) Reinterventions (2) Peripheral arterial occlusive disease (1) Nicotine abuse (1) Obesity (BMI \> 30) (1) Age \> 80 years (1) Duration of surgery \> 4 h (1) Blood loss \> 1.5 L (1) Local radiotherapy/chemotherapy (1)
Exclusion criteria
* Pregnancy or breastfeeding * Femoral access for an indication other than PAOD * Preoperative local infection or infectious skin disease * Life expectancy \< 3 months * Active infection of the ipsilateral extremity requiring systemic antibiotic therapy at the time of surgery * Systemic antibiotic therapy at the time of surgery * Use of coated incisional drapes (e.g., iodine-impregnated) * Intraoperative use of anti-infective topical agents (e.g., Gentacoll, doxycycline, etc.) * Use of fibrin sealants/thrombogenic adhesive substances above the fascia Planned postoperative prophylactic negative pressure wound therapy (NPWT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to revision surgery due to inguinal wound healing complications | within 3 months postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of wound healing complications not requiring surgical revision | within 3 months postoperatively | — |
| Time to MACE (major adverse cardiac events) (myocardial infarction, cardiovascular death, stroke) | within 3 months postoperatively | — |
| Time to MALE (major adverse limb events) (amputation, graft occlusion, unplanned repeat revascularization) | within 3 months postoperatively | — |
| course of patients quality of life over the course of wound healing | within 3 months postoperatively | Patients will be provided with the EQ-5D-5L (European Quality of Life 5 Dimensions 5 Level Version) questionnaire in order to assess quality of life at the baseline visit as well as follow-up visits 3 and 4 and after 3 months (end of study visit). The EQ-5D-5L will be evaluated by converting responses across its five domains-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-into a single health utility index using a country-specific value set (e.g., German tariff), with possible values typically ranging from below 0 (worse than death) to 1 (full health). Each domain is rated on a 5-level scale, where 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, and 5 = extreme problems/unable to perform. In addition, the EQ Visual Analogue Scale (EQ VAS) score will be analyzed separately, ranging from 0 (worst imaginable health) to 100 (best imaginable health). |
| course of estimated Glomerular Filtration Rate (eGFR) over the course of wound healing | within 3 months postoperatively | According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: eGFR ml/min/1.73m² |
| course of white blood cell count over the course of wound healing | within 3 months postoperatively | According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: white blood cell count 10\*9/L |
| course of C- reaktive protein over the course of wound healing | within 3 months postoperatively | According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: C- reaktive protein (mg/L) |
| course of procalcitonin over the course of wound healing | within 3 months postoperatively | According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: procalcitonin (ng/ml) |
| course of hemoglobin over the course of wound healing | within 3 months postoperatively | According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: hemoglobin g/dl |
| course of platelets over the course of wound healing | within 3 months postoperatively | According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: platelets 10\*9/L |
| Course of haematocrit over the course of wound healing | within 3 months postoperatively | According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: haematocrit (%) |
| course of albumin over the course of wound healing | within 3 months postoperatively | According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: albumin (g/L) |
| course of sodium over the course of wound healing | within 3 months postoperatively | According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: sodium mmol/L |
| course of potassium over the course of wound healing | within 3 months postoperatively | According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: potassium (mmol/L) |
| course of International Normalized Ratio (INR) over the course of wound healing | within 3 months postoperatively | According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: INR |
| course of partial thromboplastin time over the course of wound healing | within 3 months postoperatively | According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case:partial thromboplastin time (s) |
| course of total cholersterol over the course of wound healing | within 3 months postoperatively | According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: total cholesterol (mg/dl) |
| course of low- density- lipoprotein cholesterol (LDL cholesterol) over the course of wound healing | within 3 months postoperatively | According to clinical routine, blood samples will be collected at follow-up visits if clinically indicated, and the results will be evaluated, in this case: LDL cholesterol |
Countries
Germany
Contacts
CONTACTUrsula EM Werra, MD
Outcome results
None listed