Short-Term Safety and Performance of Two Wound Dressings Evaluation

Official title

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

Overview

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 product 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

Primary outcome measures

• Photographic evaluation [Time frame: 12 Weeks]
• Change in wound area [Time frame: 12 weeks]

Secondary outcome measures (8)

• Wound healing progression [Time frame: 12 weeks]
• Change in wound tissue composition [Time frame: 12 weeks]
• Local Infection Assessment [Time frame: 12 weeks]
• Global Tolerability Assessment [Time frame: 12 weeks]
• Pain (Visual Analogue Scale (VAS) [Time frame: 12 weeks]
• Exudate management [Time frame: 12 weeks]
• Frequency of dressing changes [Time frame: 12 weeks]
• Global Tolerability Assessment by participants [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Switzerland · 3 centers

• Geneva University Hospitals — Geneva
• Lausanne University Hospital — Lausanne
• Instituions Hospital Du Nord Vaudois — Yverdon-les-Bains

Identifiers

NCT: NCT07576322 · POLTX_Fiber · Polaroid Therapeutics

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗