Intraoperative Application of Cold Atmospheric Plasma to Prevent Postoperative Wound Complications in the Inguinal Region of High-risk Patients With Peripheral Arterial Occlusive Disease (PICPAD)
Prophylactic Application of Cold Atmospheric Plasma to Reduce Postoperative Wound Healing Disorders in the Inguinal Region in High-risk Patients With Peripheral Arterial Occlusive Disease- Intraoperative Application of Cold Atmospheric Plasma in the Inguinal Region
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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ursula EM Werra, MD
- 電話番号：0049+22147830757
- メール：ursula.werra@uk-koeln.de
研究場所
-
-
North Rhine-Westphalia
-
Cologne、North Rhine-Westphalia、ドイツ、50937
- Department of Vascular and Endovascular Surgery
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Intervention: Intraoperative application of cold atmospheric plasma
During surgery (after subcutaneous closure and prior to skin closure), patients receive a single application of cold atmospheric plasma in the area of their inguinal access wound.
|
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
|
|
偽コンパレータ：Control: Intraoperative sham application mimicking cold atmospheric plasma
During surgery (after subcutaneous closure and prior to skin closure), patients receive a sham application mimicking cold atmospheric plasma in the area of the inguinal access wound.
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Time to revision surgery due to inguinal wound healing complications
時間枠：within 3 months postoperatively
|
within 3 months postoperatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of wound healing complications not requiring surgical revision
時間枠：within 3 months postoperatively
|
within 3 months postoperatively
|
|
|
Time to MACE (major adverse cardiac events) (myocardial infarction, cardiovascular death, stroke)
時間枠：within 3 months postoperatively
|
within 3 months postoperatively
|
|
|
Time to MALE (major adverse limb events) (amputation, graft occlusion, unplanned repeat revascularization)
時間枠：within 3 months postoperatively
|
within 3 months postoperatively
|
|
|
course of patients quality of life over the course of wound healing
時間枠：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). |
within 3 months postoperatively
|
|
course of estimated Glomerular Filtration Rate (eGFR) over the course of wound healing
時間枠：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
|
within 3 months postoperatively
|
|
course of white blood cell count over the course of wound healing
時間枠：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
|
within 3 months postoperatively
|
|
course of C- reaktive protein over the course of wound healing
時間枠：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)
|
within 3 months postoperatively
|
|
course of procalcitonin over the course of wound healing
時間枠：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)
|
within 3 months postoperatively
|
|
course of hemoglobin over the course of wound healing
時間枠：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
|
within 3 months postoperatively
|
|
course of platelets over the course of wound healing
時間枠：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
|
within 3 months postoperatively
|
|
Course of haematocrit over the course of wound healing
時間枠：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 (%)
|
within 3 months postoperatively
|
|
course of albumin over the course of wound healing
時間枠：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)
|
within 3 months postoperatively
|
|
course of sodium over the course of wound healing
時間枠：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
|
within 3 months postoperatively
|
|
course of potassium over the course of wound healing
時間枠：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)
|
within 3 months postoperatively
|
|
course of International Normalized Ratio (INR) over the course of wound healing
時間枠：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
|
within 3 months postoperatively
|
|
course of partial thromboplastin time over the course of wound healing
時間枠：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)
|
within 3 months postoperatively
|
|
course of total cholersterol over the course of wound healing
時間枠：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)
|
within 3 months postoperatively
|
|
course of low- density- lipoprotein cholesterol (LDL cholesterol) over the course of wound healing
時間枠：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
|
within 3 months postoperatively
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- PICPAD-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。