Health TrialsbyHealthPanel

Investigation of the PREVENTIA® Irrigation Solution for Reducing Bacteria in Spinal Surgery With Implants - A Comparative Study

ConditionsSurgical Site Infection (SSI)Spine SurgerySurgical Site Infection Prevention
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversität Luzern

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preventia Surgical Solution

    Device

    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.

  • 0.9 % NaCl

    Device

    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.

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: Preventia Surgical SolutionExperimental treatment 1 intervention
Group B: 0.9% NaCl SolutionSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Presence of bacterial growth

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.

Time frame
Assessed 14 days postoperatively.

Secondary outcomes

1

Presence of bacterial growth

Presence of bacterial growth in each of the four individual swabs obtained around the surgical incision site.

Time frame
Assessed 14 days postoperatively.
2

bacterial species and load

Semi-quantitative assessment of bacterial species and load, reported on an ordinal scale, for each of the four individual swabs

Time frame
Assessed 14 days postoperatively
3

Surgical Site Infections

Wound healing assessment using the ASEPSIS wound scoring system. ASEPSIS stands for: * Additional treatment * Serous discharge * Erythema * Purulent exudate * Separation of deep tissues * Isolation of bacteria * Stay as inpatient prolonged over 14 days Minimum Value: 0 Maximum Value: 70 Outcome: Higher scores mean a worse outcome (greater infection severity)

Time frame
on postoperative days 3-5 and for a substudy at 90 days (±15 days) and 12 months (±2 months) post-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universität Luzern

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: