Short-Term Safety and Performance of Two Wound Dressings Evaluation

NCT07576322 | Not Yet Recruiting DMC

• 2 other identifiers: POLTX_FiberPolaroid Therapeutics
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Wound Care; Local Infection; Safety

Keywords

chronic wound; local infection prevention; wound exudate; safety

Outcome Measures

Primary Outcomes (2)

• Photographic evaluation

  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

  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

Secondary Outcomes (8)

• Wound healing progression

  12 weeks

• Change in wound tissue composition

  12 weeks

• Local Infection Assessment

  12 weeks

• Global Tolerability Assessment

  12 weeks

• Pain (Visual Analogue Scale (VAS)

  12 weeks

Other Outcomes (4)

• Sociodemographic and diagnostic data

  Baseline

• Wound etiology

  Baseline

• Wound anatonical location

  Baseline

Study Arms (2)

POLTX_Fiber arm

EXPERIMENTAL

POLTX\_Fiber, an absorbent gelling fiber dressing for moderate-high exudate chronic wounds

Combination Product: Politix Fiber arm

Suprasorb® Liquacel Pro, CE-marked gelling fiber dressing

NO INTERVENTION

Suprasorb® Liquacel Pro arm

Interventions

Politix Fiber arm COMBINATION_PRODUCT

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).

POLTX_Fiber arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sebastian Probst: lead
• eHnv Hospital: collaborator
• University Hospital, Geneva: collaborator
• CHUV, Lausanne University Hospitals, Switzerland: collaborator

Study Sites (3)

Geneva University Hospitals

Geneva, Canton of Geneva, 1205, Switzerland

Location

Lausanne University Hospital

Lausanne, Canton of Vaud, 1002, Switzerland

Location

Instituions Hospital Du Nord Vaudois

Yverdon-les-Bains, Canton of Vaud, 1400, Switzerland

Location

Central Study Contacts

Sebastian Probst, Prof. Dr.

CONTACT

41 22-558-6563; sebastian.probst@hesge.ch

André Frei, MSc

CONTACT

41 22-558-6050; andre.frei@hesge.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Tissue Viability and Wound Care

Model Details: Evaluate the clinical performance and safety of POLTX\_Fiber compared to Suprasorb® Liquacel Pro in an outpatient clinical setting

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 14, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: from 2028 until 2029
• Access Criteria: all researchers

Locations

CH (3)