Effectiveness of Silicone Superabsorbent Polymer Dressings for Chronic Wound Management

HARTMANN GROUP80 enrolled

Overview

The purpose of this single arm clinical study is to find out how well two Silicone superabsorbent polymer dressings, RespoSorb Silicone (also known as Zetuvit Plus Silicone) and RespoSorb Silicone Border (also known as Zetuvit Plus Silicone Border), work in treating long lasting wounds on the lower legs or feet. The main goal of the study is to see whether these dressings help reduce wound size over time. The study also looks at whether the dressings improve the condition of the wound and the surrounding skin. In addition, patients are asked about their experience with the dressings, including whether they help reduce pain and how satisfied patients are with the treatment.

This prospective, non comparative, single arm clinical investigation is conducted as part of Post Market Clinical Follow up (PMCF) activities to evaluate the clinical performance and safety of two Silicone SAP dressings: RespoSorb Silicone (RSSil; also marketed as Zetuvit Plus Silicone) and RespoSorb Silicone Border (RSSB; also marketed as Zetuvit Plus Silicone Border) in the management of chronic, exuding lower extremity wounds. Approximately 80 evaluable adult patients with a single chronic VLU or DFU will be enrolled at 7 to 10 clinical sites in Poland, including outpatient clinics and hospitals. In each dressing group, at least 35% of patients will have VLU and at least 35% DFU. Patients with VLU will receive compression therapy, and patients with DFU will use appropriate offloading devices throughout the study. Patients will be followed for up to 6 weeks or until wound healing, discontinuation, withdrawal, or occurrence of an adverse event preventing further participation. The primary objective is to evaluate the potential clinical effectiveness of RSSil and RSSB in reducing wound size over time. Wound area will be measured objectively by planimetry using standardized photographs taken at each visit. Secondary outcomes include changes in wound tissue composition (granulation and slough), exudate amount and type, peri wound skin condition, frequency of dressing changes, and patient reported outcomes such as treatment benefit and wound related quality of life. Physical activity will be assessed using a wrist worn accelerometer, and compliance with compression therapy (VLU) or offloading devices (DFU) will be documented. In addition, healthcare professionals will provide feedback on usability and overall experience with the dressings. Safety will be assessed by monitoring and recording device related adverse events and device deficiencies throughout the study. Data will be captured using an electronic case report form and analyzed primarily using an intention to treat approach.

Study Type

Interventions

RespoSorb Silicone (RSSil)DEVICE

RespoSorb Silicone is a Silicone Superabsorbent Polymer (SAP) dressing intended for the management of chronic, exuding lower extremity wounds. The dressing consists of a superabsorbent core designed to absorb and retain wound exudate and a soft silicone contact layer that allows gentle adhesion to the peri-wound skin while minimizing trauma and pain during dressing changes. RespoSorb Silicone is applied directly to the wound bed and secured with an appropriate secondary fixation according to standard clinical practice and the manufacturer's Instructions for Use. Dressing changes are performed as clinically indicated. Treatment is continued for up to 6 weeks or until wound healing, discontinuation, or withdrawal.

RespoSorb Silicone Border (RSSB)DEVICE

RespoSorb Silicone Border is a Silicone Superabsorbent Polymer (SAP) dressing intended for the management of chronic, exuding lower extremity wounds. The dressing combines a superabsorbent core for effective exudate absorption and retention with a soft silicone contact layer to minimize disruption of the wound and peri-wound skin. The dressing includes an integrated adhesive silicone border that provides secure fixation without the need for additional secondary dressings. RespoSorb Silicone Border is applied according to standard clinical practice and the manufacturer's Instructions for Use. Dressing changes are performed as clinically indicated. Treatment is continued for up to 6 weeks or until wound healing, discontinuation, or withdrawal.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is 18 years of age or older and has given formal written consent. * Diagnosed with a chronic, exuding lower extremity wound of a single limb: * Venous leg ulcer (VLU) or * Diabetic Foot Ulcer (DFU). * Target ulcer persists since min. 1 and max. 12 months prior to screening. * An appropriate dressing size is available to be used according to the size of the target ulcer, the ulcer size shall be no longer than 10 cm in one dimension. * Target ulcer is not clinically infected ( Clinically infected wound is defined as a wound that required the use of systemic antibiotics or topical antimicrobials ). * Ankle-brachial pressure index (ABPI) is between 0.8 and 1.2 measured during the Screening or within 30 days prior to the Screening Visit. If ABPI is \>1.2 the Toe-Brachial Index (TBI) should be \>0.6. * Presence of an ulcer extending through the full thickness of the skin but not down to muscle, tendon or bone. * For VLU: Patient is suitable for and agrees to use compression therapy (PütterPro2 or PütterPro2 Lite) for the study duration and was using compression therapy before study inclusion. * For VLU: Patient is able to walk in conjunction to compression therapy. Ankle mobility is fully mobile to limited mobile. * For DFU: Patient is suitable and agrees to use offloading devises for the study duration. * For DFU: Patient is able to walk in conjunction to offloading devices. Ankle mobility is fully mobile to limited mobile. Exclusion Criteria: * Known allergies/hypersensitivity or intolerance to any of the study product ingredients. * Patients with ischemic diabetic foot ulcers. * Patients with more than two full-thickness lower extremity ulcers on the same limb or greater than a total of three full-thickness lower-extremity ulcers. * Target ulcer is clinically infected according to the judgement of HCP or suspected to be clinically infected that could require systemic antibiotics at the time of screening or during the study. * Treatment with local or systemic antimicrobial therapy within 7 days prior to Screening visit or during the study duration. * According to physician's assessment, the patient is not able to follow the study protocol (e.g. due to cognitive disease) or is not able to understand state, nature, meaning and consequences of the study. * Patient suffers from active autoimmune disease requiring corticosteroid treatment (\> 10 mg prednisolone equivalent/day) and/or other immunosuppressive (e.g. cyclosporine (\>10mg/kg), methotrexate (\>10mg/week), TNF inhibitors (e.g. infliximab) and/ or chemotherapy within 7 days prior to Screening visit or during the study duration. * Application of topical steroids to the ulcer surface 7 days prior to treatment or during the course of the study. * Hyperbaric treatment 7 days prior to treatment or during the course of the study. * Bioengineered tissue product usage on the target ulcer four weeks prior to treatment or during the course of the study. * Patients with clinically significant intermittent claudication (the symptoms significantly impact a person's ability to walk and perform daily activities). * Patients where the full dimensions of their leg ulcer could not be measured (it must be possible to display the entire wound area on one photo from a distance of 25-30 cm). * Wound is caused by malign tumor (primary or metastasis). Any malignancy within the past three years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. * History of radiation to the target ulcer site within 12 months prior to screening. * Patients with known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history known to be infected with Human Immunodeficiency Virus (HIV). * Recurrent ulcer (the target ulcer has re-occurred within 12 months after its complete closure). * Patients with NYHA Class IV congestive heart failure (CHF). * Patients with hypertensive leg ulcers (Ulcus cruris hypertonicum Martorell). * Patient suffers from septic phlebitis, severe deep vein thrombosis (phlegmasia cerulea dolens) or other conditions posing a contraindication for compression therapy according to established guidelines and local procedures (e.g. significant sensory neuropathy). * In addition to study product, further products in direct contact to wound surface will be used. * Documented history of osteomyelitis at the target ulcer location within six months preceding the screening visit. * Patients with oedema that cannot be controlled with compression therapy. * Patient suffers from poorly controlled diabetes (Hb1Ac ≥ 8.6%) measured within 3 months before screening or at the time of screening visit. * Patient suffered from significant malnutrition with reduced serum albumin levels - serum albumin concentration is below 3.5 g/dL measured within 2 weeks before screening or at the time of screening visit. * Patients with a known history of alcohol use disorder and substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) within the past year. * Participation in any interventional study in the last 7 days before beginning of this study. * Patients with severe obesity (BMI\>40) that limited their mobility. * Female patients of childbearing age not using contraception, pregnancy (suspected or confirmed), or breast-feeding women.

Locations (8)

JBS Klinika Spółka Z Ograniczoną Odpowiedzialnością

Gdansk, Poland

MelissaMed Poradnia Chirurgiczna

Lodz, Poland

MIKOMED Spółka Z Ograniczoną Odpowiedzialnością

Lodz, Poland

Niepubliczny Zakład Opieki Zdrowotnej "Argo" Centrum Medyczne

Lodz, Poland

Specjalistyczny Osrodek Leczniczo Badawczy, Zbigniew Żęgota

Ostróda, Poland

PODOVIA Sp. z o.o.

Poznan, Poland

Niepubliczny Specjalistyczny Zakład Opieki Zdrowotnej "Medicus", Poradnia Chirurgiczna

Środa Wielkopolska, Poland

Lecran - Centrum Opieki Nad Ranami-Kunickiego

Wroclaw, Poland

Outcomes

Primary Outcomes

Wound area reduction

Clinical effectiveness will be assessed by the change in wound area of the target ulcer over time. Wound area will be calculated in square centimeters (cm²) using planimetric analysis based on standardized digital photographs taken at each study visit. The study has established a threshold for clinical significance, defining a minimum reduction in the wound area of 20%.

Time frame: Up to 6 weeks (maximum total treatment period), or until wound healing, withdrawal, or discontinuation, whichever occurs first

Secondary Outcomes

Change in granulation tissue over time

Change in the proportion of the wound surface covered by granulation tissue will be assessed over time. Granulation tissue area (%) before and after cleansing/debridement will be evaluated based on standardized wound photographs obtained at each study visit. Changes in the coverage by granulation tissue at baseline and at the final visit determined as: None, 1%-24%, 25%-49%, 50%-74%, or 75%-100%.

Time frame: Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first

Change in Slough Tissue Over Time

Change in the proportion of the wound surface covered by slough tissue will be assessed over time. Slough tissue area (%) before and after cleansing/debridement will be evaluated using standardized wound photographs taken at each study visit. Changes in the coverage by slough tissue at baseline and at the final visit determined as: None, 1%-24%, 25%-49%, 50%-74%, or 75%-100%.

Time frame: Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first

Change in Exudate Amount Over Time

Exudate amount will be quantified as the fluid volume retained in each dressing. This will be calculated as the difference between wet and dry dressing weight, divided by the exudate fluid density (1.03 g/cm³). The exudate retention volume will be calculated as the daily exudate retention volume by dividing the fluid volume (V) by the wearing time (days) recorded in eCRF. Change in the daily exudate volume from baseline to the final visit in mL will be quantified.

Time frame: Weekly assessments during the treatment period, up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.

Change in Exudate Type Over Time

Exudate type will be assessed qualitatively by the healthcare professional and classified as serous, sanguineous, serosanguineous, seropurulent, fibrinous, purulent, hemopurulent, or hemorrhagic. Changes in particular exudate types at baseline and the final visit will be assessed,

Time frame: Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first

Improvement of Peri-Wound Skin Condition Over Time

Peri-wound skin condition will be evaluated visually by the investigator or designee for the presence or absence of maceration, erythema/redness, dry skin, and other peri-wound skin abnormalities. Changes in peri-wound skin condition from baseline to the final visit will be assessed.

Time frame: Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.

Patient-Reported Treatment Benefit (PBI-W)

Patient-reported treatment benefit will be assessed using the Patient Benefit Index for Wounds (PBI-W), which evaluates the patient's perceived benefit of treatment. Changes in the global PBI score at baseline and the final visit will be calculated. The global PBI-W score ranges from 0 (no patient-relevant treatment benefit) to 4 (maximum patient-relevant treatment benefit), with positive change indicating increased perceived benefit.

Time frame: Assessed at baseline and at the end of treatment at 6 weeks or until healed or withdrawal/discontinuation, whichever occurs first.

Quality of Life of patients with chronic wounds

Wound-related quality of life will be assessed using the Wound-QoL-17 questionnaire, which measures disease-specific health-related quality of life over the preceding 7 days. Changes in the Wound-QoL 17 global score at baseline and final visit will be calculated. The global score ranges from 0 to 4, with higher scores indicating greater impairment in wound-related quality of life; therefore, a decrease in score represents an improvement in quality of life.

Time frame: Assessed at baseline and at the end of treatment at 6 weeks or until healed or withdrawal/discontinuation, whichever occurs first.

Change in weekly Average Active Intensity

Activity intensity will be assessed using a wrist-worn accelerometer applied at baseline and worn throughout the study period. Active intensity per day is defined as the mean activity intensity of all periods classified as active (light, moderate, or vigorous activity) within a 24-hour period and expressed in metabolic equivalents (METs). Daily values will be aggregated to derive weekly average active intensity for each participant. Changes between week 1 and week 6 will be calculated.

Time frame: Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.

Change in Weekly Average Active Volume

Active volume will be assessed using a wrist-worn accelerometer applied at baseline and worn throughout the study period. Active volume per day represents the cumulative activity dose over a 24-hour period, calculated by integrating activity intensity across all recorded activity events and expressed as metabolic equivalent minutes per day (MET-minutes/day). Daily values will be aggregated to compute weekly average active volume per participant. Change in Active volume between week 1 and week 6 will be calculated.

Time frame: Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.

Change in Weekly Average Moderate-to-Vigorous Physical Activity (MVPA) Duration

MVPA duration will be assessed using a wrist-worn accelerometer applied at baseline and worn throughout the study period. MVPA duration is defined as the total daily time spent in activity exceeding predefined intensity thresholds corresponding to moderate or vigorous activity and reported in hours. Daily values will be aggregated to compute weekly average MVPA duration per participant. Change in MVPA duration between week 1 and week 6 will be calculated.

Time frame: Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.

Change in Weekly Average Active-to-Inactive Duration Ratio

The active-to-inactive duration ratio will be assessed using a wrist-worn accelerometer applied at baseline and worn throughout the study period. Active duration includes all periods classified as light, moderate, or vigorous activity. Inactive duration includes all inactive time excluding sleep. Daily values will be aggregated to compute weekly average active-to-inactive duration ratios per participant. Change in active-to-inactive duration ratio between week 1 and week 6 will be calculated.

Time frame: Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.

Change in Weekly Average Sit-to-Stand Transitions

The sit-to-stand transitions will be assessed using a wrist-worn accelerometer applied at baseline and worn throughout the study period. Sit-to-stand transitions is defined as posture changes from sitting or lying to standing occurring within a 24-hour period. Daily counts will be aggregated to compute weekly average sit-to-stand transitions per participant. Change in sit-to-stand transitions between week 1 and week 6 will be calculated.

Time frame: Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.

Change in Weekly Average Total Sleep Duration

Sleep outcomes will be assessed using a wrist-worn accelerometer applied at baseline and worn throughout the study period. Total sleep duration is defined as the cumulative duration of all detected sleep events within a 24-hour period and reported in hours. Daily values will be aggregated to derive weekly average total sleep duration per participant. Change in total sleep duration between week 1 and week 6 will be calculated.

Time frame: Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.

Change in Weekly Average Sleep Efficiency

Sleep outcomes will be assessed using a wrist-worn accelerometer applied at baseline and worn throughout the study period. Sleep Efficiency is defined as the as the percentage of time spent asleep relative to the total rest interval duration. Daily sleep efficiency values were aggregated to compute weekly average sleep efficiency per participant. Change in sleep efficiency between week 1 and week 6 will be calculated.

Time frame: Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.

Change in Weekly Average Sleep Onset Latency

Sleep outcomes will be assessed using a wrist-worn accelerometer applied at baseline and worn throughout the study period. Sleep Onset Latency is defined as the elapsed time between the start of the nightly rest interval and the onset of the first detected sleep episode, expressed in hours. Daily sleep onset latency values were aggregated to obtain weekly average sleep onset latency per participant. Change in sleep onset latency between week 1 and week 6 will be calculated.

Time frame: Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first.

Social support and satisfaction assessment

Perceived social support and treatment satisfaction will be assessed using the Multidimensional Scale of Perceived Social Support (SSQ). The SSQ is a patient-reported questionnaire that evaluates perceived support from family, friends, and significant others. The instrument consists of 12 items, each rated on a 7-point Likert scale ranging from 1 ("very strongly disagree") to 7 ("very strongly agree"). The global SSQ score is calculated as the mean of all items and ranges from 1 to 7, with higher scores indicating greater perceived social support and lower scores indicating lower perceived support.

Time frame: Assessed once during the treatment period of 6 weeks, until healed or withdrawal/discontinuation, whichever occurs first.

For patients with VLU: Compliance with compression therapy

Compliance with compression therapy (for venous leg ulcer patients) will be assessed using patient diaries and visit assessments. Compliance will be categorized as fully compliant (defined as 7 out of 7 days with compression), moderately compliant (defined as 1 to 3 days without compression out of 7 days), or not compliant (defined as \>3 days without compression out of 7 days).

Time frame: Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first

For patients with DFU: Compliance to offloading

Compliance with offloading devices (for diabetic foot ulcer patients) will be assessed using patient diaries and visit assessments. Compliance will be categorized as fully compliant (defined as 7 out of 7 days with offloading), moderately compliant (defined as 1 to 3 days without offloading out of 7 days), or not compliant (defined as \>3 days without offloading out of 7 days).

Time frame: Up to 6 weeks, or until wound healing, withdrawal, or discontinuation, whichever occurs first

Effectiveness of Silicone Superabsorbent Polymer Dressings for Chronic Wound Management

Overview

Conditions

Interventions

Eligibility

Locations (8)

Outcomes

Primary Outcomes

Secondary Outcomes