Short-Term Safety and Performance of Two Wound Dressings Evaluation

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.

Conditions

• Chronic Wound Care
• Local Infection
• Safety

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 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 & Collaborators

• eHnv Hospital

  collaborator UNKNOWN

• University Hospital, Geneva

  collaborator OTHER

• CHUV, Lausanne University Hospitals, Switzerland

  collaborator UNKNOWN

• Sebastian Probst

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-15

Primary Completion

2027-06-14

Completion

2027-09-30

Countries

• Switzerland

Study Locations