Chronic Wound Care, Local Infection, Safety
Conditions
Keywords
chronic wound, local infection prevention, wound exudate, safety
Brief summary
Chronic wounds, including venous leg ulcers, diabetic foot ulcers, and pressure ulcers, are defined as wounds that fail to heal within 4-8 weeks despite appropriate care. They represent a significant health burden due to prolonged healing, risk of infection, recurrence, and impact on quality of life and healthcare costs. Their development is multifactorial and often linked to vascular impairments, which reduce oxygen and nutrient supply. This leads to impaired tissue repair, persistent inflammation, and increased susceptibility to infection. Standard treatment includes wound debridement, infection control, maintaining a moist environment, and managing pain and exudate. POLTX\_Fiber is an absorbent gelling fiber dressing designed to improve moisture balance, manage exudate, and reduce bacterial load, with established safety and CE marking. A post-market clinical follow-up study will compare POLTX\_Fiber with Suprasorb® Liquacel Pro over a 30-day period in an outpatient setting. The study evaluates wound healing, infection status, usability, pain, and patient satisfaction. It is conducted in accordance with EU and Swiss regulations, ensures qualified investigators, and considers sex and gender differences in the analysis.
Detailed description
Chronic wounds, including venous leg ulcers, diabetic foot ulcers, and pressure ulcers, represent a growing healthcare burden, associated with delayed healing, high recurrence rates, and reduced quality of life. Their pathophysiology is multifactorial, involving impaired perfusion, dysregulated inflammation, and bacterial colonization, all of which contribute to prolonged healing. Effective wound management requires control of exudate, maintenance of a moist wound environment, and management of microbial burden. Absorbent gelling fiber dressings are commonly used for this purpose; however, comparative clinical evidence between available products remains limited. POLTX\_Fiber is a CE-marked absorbent gelling fiber dressing intended to support exudate management and wound healing. Additional clinical data are needed to further evaluate its performance under routine clinical conditions, in line with post-market clinical follow-up (PMCF) requirements under Regulation (EU) 2017/745. This study aims to evaluate the clinical performance and safety of POLTX\_Fiber in patients with chronic wounds in an outpatient setting, compared with a standard gelling fiber dressing. The primary objective is to assess changes in wound surface area over a 30-day treatment period. Secondary objectives include evaluation of wound condition, patient outcomes, and device usability. This is a multicenter, non-randomized, controlled, open-label PMCF study conducted in outpatient care. Eligible patients will receive either POLTX\_Fiber or a comparator dressing as part of routine clinical practice.
Interventions
COMBINATION_PRODUCTPolitix Fiber arm
POLTX\_Fiber, an absorbent gelling fiber dressing for moderate-high exudate chronic wounds, applied strictly per IFU and local protocol. Application workflow (per visit). It will proceed as follows: * Removal of old dressing. * Application of analgesic if necessary (timed to peak during debridement/dressing). * Debridement if necessary (sharp/hydrolytic per local practice; document method/date). * Wound cleansing (sterile 0.9% saline or Ringer's; no antiseptics) (IWII 2025). * Application of a suitable secondary dressing according to wound phase and medical prescription to secure the primary and maintain moisture balance. * Compression therapy for venous disease according to the standardized procedure described in Section 6.1; apply off-loading for DFU per local SOP where indicated. * Documentation in the eCRF (Imito Wound® digital photographs/planimetry, tissue composition, exudate character, TILI infection score, VAS pain, any device deficiencies).
Sponsors
Sebastian Probst
eHnv Hospital
University Hospital, Geneva
CHUV, Lausanne University Hospitals, Switzerland
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Statistician
Intervention model description
Evaluate the clinical performance and safety of POLTX\_Fiber compared to Suprasorb® Liquacel Pro in an outpatient clinical setting
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age ≥ 18 years Chronic wound of 4 weeks to 2 years in duration Moderate to highly exuding wound (clinician-assessed) Wound area 2-50 cm² after debridement Able and willing to provide informed consent and comply with study procedures
Exclusion criteria
Known hypersensitivity to study or comparator dressing components Clinically infected wound requiring systemic antibiotics at baseline Necrotic wound (\>25% necrotic tissue) or malignant wound Severe arterial insufficiency (ABI \< 0.5) Pregnant or breastfeeding Severe comorbid condition likely to interfere with wound healing or safety evaluation (e.g., end-stage renal disease, active cancer on chemotherapy, immunosuppression) Participation in another interventional study within 30 days Use of investigational wound products within 30 days Cognitive or psychiatric condition limiting consent or compliance Unable to attend follow-up visits or likely to relocate during the study period Any condition that, in the investigator's judgment, may compromise safety or study integrity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photographic evaluation | 12 Weeks | Standardized photographs will be obtained using ImitoWound® after dressing removal, wound debridement (if applicable) and wound cleansing at a frequency of no more than once per week, even if multiple dressing changes take place during the same week. ImitoWound® will be used in an iPad as instructed in supplier's wound imaging and measurement guidelines. The camera of the iPad will be maintained 20 to 30 cm away from and parallel to the wound. A calibration marker (quick response \[QR\] code) will be positioned next to and in the same plane of the wound, and a photograph will be taken after recognition of the QR code by ImitoWound®, providing automatic wound measurements. This marker will allow standardised image captures maintaining fixed distance, lighting, and calibration. Study nurses will receive concise training and a working instruction with step-by-step procedure on how to use ImitoWound®. Images will be anonymized and centrally reviewed by two blinded assessors; discrepancies \> |
| Change in wound area | 12 weeks | Wound area (length, width, depth, area) will be recorded using ImitoWound®. Percent wound area reduction (PWAR) from baseline to EoT (Day 30) or follow-up (Week 8 and Week 12) will be computed automatically using the following formula: PWAR = \[(Wound area at baseline - Wound area at follow-up) / Wound area at baseline\] × 100. Higher percentages indicate faster healing. Where digital imaging is unavailable, manual planimetry measurements may be used and documented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing progression | 12 weeks | Wound healing progression over 12 weeks will be measured from pictures of the wound taken with ImitoWound |
| Change in wound tissue composition | 12 weeks | Change from baseline in wound tissue composition, as assessed using digital wound assessment technology. Tissue composition (e.g. granulation, slough, necrosis) will be determined automatically through ImitoWound® image analysis at baseline and when wound images are captured during wound care. Results will be expressed as a percentage of total wound area (sum = 100%), enabling consistent quantification of healing dynamics over time. |
| Local Infection Assessment | 12 weeks | Local infection will be evaluated at each visit using the Therapeutic Index for Local Infection (TILI), a validated clinical tool for early infection detection (erythema, peri-wound oedema, malodour, exudate change, pain). A TILI score ≥ 5 indicates clinically relevant infection requiring medical evaluation or treatment adjustment. |
| Global Tolerability Assessment | 12 weeks | Usability of POLTX\_Fiber will be assessed using a short Investigator Usability and Handling Questionnaire based on ISO 14155:2020 and FDA Human Factors guidance (2016). Parameters include ease of application/removal, dressing integrity, handling characteristics, and overall satisfaction. Rated on a 5-point Likert scale (Total score ranges from 5 to 22). |
| Pain (Visual Analogue Scale (VAS) | 12 weeks | Pain will be recorded at each dressing change using a 10-cm VAS (0 = no pain, 10 = worst pain imaginable). Pain on application, during wear, and on removal will be documented. |
| Exudate management | 12 weeks | Assessment of characteristics of wound exudate In addition to color and odor of wound exudate will be recorded using simplified Keast (2022) descriptors: * Color: serous (clear/amber), serosanguinous (pink), purulent (opaque/yellow/green). * Odor: absent, faint, moderate, strong. Abrupt increases in volume or the emergence of purulent/strongly malodorous exudate will trigger reassessment of the TILI Score and clinical review to rule out infection. |
| Frequency of dressing changes | 12 weeks | The total number of dressing changes (scheduled and unscheduled) during the thirty-day treatment will be recorded in the eCRF. Each entry will include: * Date and time of change * Reason (e.g., exudate saturation, leakage, odor, clinical judgement) * Dressing type (POLTX\_Fiber vs SoC) * Cumulative dressing count Participants will be categorized as ≤2 changes/week, 3-4 changes/week, or ≥5 changes/week. Lower dressing-change frequency indicates better absorbency and longer wear time. |
| Global Tolerability Assessment by participants | 12 weeks | Patients will independently assess tolerability on a 3-point scale (Chandanwale 2014): 0 = No issues, 1 = Moderate, 2 = Poor. |
Countries
Switzerland
Contacts
CONTACTSebastian Probst, Prof. Dr.
CONTACTAndré Frei, MSc
Outcome results
None listed