Investigation of the PREVENTIA® Irrigation Solution for Reducing Bacteria in Spinal Surgery With Implants - A Comparative Study (PROTECT-SPINE)
2026年6月24日 更新者：Rami Sommerstein、Universität Luzern
Prevention of Bacterial Contamination in Spinal Fusion Surgery Using Polyhexanide-Poloxamer Wound Irrigation - a Randomized Clinical Trial
Spinal surgery carries a risk of surgical wound infections (i.e., the entry of bacteria).
Despite various preventive measures, such infections continue to occur, particularly in operations involving implants.
In this study, we would like to investigate whether rinsing the surgical wound with a special irrigation solution called PREVENTIA® can reduce the number of bacteria in the wound during the operation.
調査の概要
詳細な説明
Surgical wound infections are among the possible complications following spinal surgery.
There is a particularly increased risk of such infections in operations in which implants, such as screws or rods to stabilize the spine, are used.
One reason for these infections is that many different bacteria live on human skin.
These are found not only on the surface of the skin, but also in deeper layers of the skin, for example in hair follicles and sebaceous glands.
In these areas, they cannot always be fully reached by conventional disinfectants before surgery.
As a result, bacteria can enter the surgical site despite careful preparation.
This study investigates a special irrigation solution called PREVENTIA®.
It contains active substances, polyhexanide and poloxamer, which can kill bacteria and attack so-called biofilms.
A biofilm is a type of protective layer that bacteria form on implants.
Within this layer, the bacteria are better protected and can cause infections that are more difficult to treat.
Until now, this solution has mainly been used for irrigating superficial wounds.
However, it has not yet been investigated whether irrigating deeper tissue layers during spinal surgery can reduce the presence of bacteria.
This study therefore aims to investigate: whether irrigating the surgical wound with PREVENTIA® results in fewer detectable bacteria in the surgical site, and whether this method may potentially help to reduce infections in the surgical site.
研究の種類
介入
入学 (推定)
114
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Rami Sommerstein, Prof. Dr. Med.
- 電話番号：+41 41 208 32 54
- メール：rami.sommerstein@unilu.ch
研究場所
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Lucerne、スイス、6006
- Hirslanden Klinik St. Anna
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コンタクト：
- Ellinor Wyss
- 電話番号：+41799004264
- メール：ellinorwyss@hotmail.com
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副調査官：
- Ellinor Wyss
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副調査官：
- Oliver P Gautschi, Prof. Dr. med.
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Age more than 18 years
- Plan to undergo elective spinal fusion surgery (including thoracic and lumbar vertebrae, and sacrum and coccyx)
- Informed consent as documented by signature
Exclusion Criteria:
- Emergency spine surgery
- Previous spine fusion surgery
- Unable to follow the comply with the study procedure or provide informed consent
- Known allergies to any of the products used in the trial
- Female gender
- Current or recent (last 14 days) antibiotic therapy
- Participation in another trial with an antimicrobial substance within the 30 days preceding and during the present trial
- Known or suspected drug or alcohol abuse
- Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
- Evidence or suspicion of preexisting infection, defined as:
Current local infection (or active treatment) involving the spine or adjacent soft tissues (e.g. spondylodiscitis, epidural or paravertebral abscess, cellulitis at the intervention site) diagnosed clinically or by imaging prior to intervention; Active systemic bacterial/fungal infection requiring antimicrobial therapy
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Preventia Surgical Solution
PREVENTIA® Surgical Irrigation is a CE-marked solution containing 0.1% polyhexanide (PHMB) and poloxamer, with proven antimicrobial and anti-biofilm activity.
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Irrigation of the surgical wound with 0.1% polyhexanide and poloxamer and instillation for 1 minute instilled with the amount needed to fill up to the wound border before and after placement of the pedicle screws and before opening of the spinal canal (to guarantee no contact with the dura mater).
This procedure is followed by complete aspiration of the fluid.
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偽コンパレータ：0.9% NaCl Solution
Irrigation solution without intrinsic antimicrobial properties
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Irrigation of the surgical wound with 0.9% NaCl and instillation for 1 minute instilled with the amount needed to fill up to the wound border before and after placement of the pedicle screws and before opening of the spinal canal (to guarantee no contact with the dura mater).
This procedure is followed by complete aspiration of the fluid.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Presence of bacterial growth
時間枠：Assessed 14 days postoperatively.
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Presence of bacterial growth in at least one of four intraoperative swabs (deep wound swab 1 or 2, retractor swab, or surgical glove swab) obtained around the surgical incision site.
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Assessed 14 days postoperatively.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Presence of bacterial growth
時間枠：Assessed 14 days postoperatively.
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Presence of bacterial growth in each of the four individual swabs obtained around the surgical incision site.
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Assessed 14 days postoperatively.
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bacterial species and load
時間枠：Assessed 14 days postoperatively
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Semi-quantitative assessment of bacterial species and load, reported on an ordinal scale, for each of the four individual swabs
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Assessed 14 days postoperatively
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Surgical Site Infections
時間枠：on postoperative days 3-5 and for a substudy at 90 days (±15 days) and 12 months (±2 months) post-surgery
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Wound healing assessment using the ASEPSIS wound scoring system. ASEPSIS stands for:
Minimum Value: 0 Maximum Value: 70 Outcome: Higher scores mean a worse outcome (greater infection severity) |
on postoperative days 3-5 and for a substudy at 90 days (±15 days) and 12 months (±2 months) post-surgery
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年1月1日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年6月18日
QC基準を満たした最初の提出物
2026年6月18日
最初の投稿 (実際)
2026年6月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月29日
QC基準を満たした最後の更新が送信されました
2026年6月24日
最終確認日
2026年6月1日
詳しくは
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。