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Short-Term Safety and Performance of Two Wound Dressings Evaluation (POLTX_Fiber)

4 maj 2026 uppdaterad av: Sebastian Probst

A Post-Market Clinical Follow-Up Study to Evaluate Short-Term Safety and Performance of POLTX_Fiber Compared With Suprasorb Liquacel Pro in Chronic Wounds

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Schweiz
    • Canton of Geneva
      • Geneva, Canton of Geneva, Schweiz, 1205
        • Geneva University Hospitals
        • Kontakt:
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Schweiz, 1002
        • Lausanne University Hospital
        • Kontakt:
      • Yverdon-les-Bains, Canton of Vaud, Schweiz, 1400
        • Instituions Hospital Du Nord Vaudois
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: POLTX_Fiber arm
POLTX_Fiber, an absorbent gelling fiber dressing for moderate-high exudate chronic wounds
Kombinationsprodukt: Politix 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).
Inget ingripande: Suprasorb® Liquacel Pro, CE-marked gelling fiber dressing
Suprasorb® Liquacel Pro arm

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Photographic evaluation
Tidsram: 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 >
12 Weeks
Change in wound area
Tidsram: 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.
12 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Wound healing progression
Tidsram: 12 weeks
Wound healing progression over 12 weeks will be measured from pictures of the wound taken with ImitoWound
12 weeks
Change in wound tissue composition
Tidsram: 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.
12 weeks
Local Infection Assessment
Tidsram: 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.
12 weeks
Global Tolerability Assessment
Tidsram: 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).
12 weeks
Pain (Visual Analogue Scale (VAS)
Tidsram: 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.
12 weeks
Exudate management
Tidsram: 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.
12 weeks
Frequency of dressing changes
Tidsram: 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.
12 weeks
Global Tolerability Assessment by participants
Tidsram: 12 weeks
Patients will independently assess tolerability on a 3-point scale (Chandanwale 2014): 0 = No issues, 1 = Moderate, 2 = Poor.
12 weeks

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sociodemographic and diagnostic data
Tidsram: Baseline

At Screening, investigators will collect the following information and record it in the electronic Case Report Form (eCRF):

  • Sociodemographic data (age, sex, occupation, level of mobility, living situation).
  • Relevant comorbidities (e.g., diabetes, peripheral vascular disease, venous insufficiency).
  • Current medications or topical wound treatments.
  • Lifestyle factors (smoking and alcohol use).
Baseline
Wound etiology
Tidsram: Baseline
At Baseline, wound etiology (e.g., venous leg ulcer, diabetic foot ulcer, pressure ulcer) will be documented
Baseline
Wound anatonical location
Tidsram: Baseline
Wound anatomical location will be documented at baseline
Baseline
Wound diagnostic classification
Tidsram: Baseline
Wound diagnostic classification (if applicable, e.g., Wagner grade for diabetic ulcers or EPUAP stage for pressure ulcers).
Baseline

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sebastian Probst

Samarbetspartners

University Hospital, Geneva
eHnv Hospital
CHUV, Lausanne University Hospitals, Switzerland

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 juni 2026

Primärt slutförande (Beräknad)

14 juni 2027

Avslutad studie (Beräknad)

30 september 2027

Studieregistreringsdatum

Först inskickad

23 april 2026

Först inskickad som uppfyllde QC-kriterierna

4 maj 2026

Första postat (Faktisk)

8 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • POLTX_Fiber
  • Polaroid Therapeutics (Annan identifierare: Polaroid Therapeutics)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Raw data will be shared using Yareta (https://yareta.unige.ch/home) a Swiss research platform using the FAIR priniples

Tidsram för IPD-delning

from 2028 until 2029

Kriterier för IPD Sharing Access

all researchers

IPD-delning som stöder informationstyp

  • ANALYTIC_CODE

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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