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The fluid handling capacity of superabsorbent dressings varies depending on the design and construction. The use of effective advanced wound dressings is a promising strategy to achieve adequate absorption of wound exudate and malodour promoting wound healing. The aim of the current study is to determine whether there is a difference in the clinical performance of exudate absorption with two commonly used CE-marked superabsorbent dressings when used on VLUs in routine wound care.
As primary objective the dressing´s absorption performance and its ability to prevent skin maceration and leakage of the wound dressing will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cutimed Sorbion products | Experimental | Within this arm the Cutimed Sorbion (Cutimed® Sorbion® Sachet/Sana/Border) products will be used for exudate managment. |
|
| Zetuvit (RespoSorb) products | Active Comparator | Within this arm the comperator products Zetuvit® Plus/(RespoSorb® Super), Zetuvit® Plus Silicone/(RespoSorb® Silicone) and Zetuvit® Plus Silicone Border/(RespoSorb® Silicone Border) will be used for exudate management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Superabsorbent dressing application | Device | Cutimed Sorbion or Zetuvit plus (RespoSorb) application to maintain wound exudate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exudate management performance | Capability to main exudate uptake and retention as well as leakage prevention | up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Dressing change frequency | Number of required intermediate dressing changes between study visits and assessement fo reasons for | up to 30 days |
| Moisture-associated skin damages | Occurrence of moisture-associated skin damages |
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Inclusion Criteria:
Exclusion Criteria:
8. Participant suffers from alcohol or drug addiction or is substituted e.g., by Methadone 9. Participant is or has been included in another clinical investigation with medical devices or pharmaceutical drugs at present or during the past 30 days 10. Participant with a history of sensitivity to any of the components of the study product 11. Participant whose leg ulcers are clinically infected (e.g., erysipelas) or malignant 12. Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the trial 13. The ulcer has exposed bone, tendon, ligaments and/or joint 14. History of radiation at the study ulcer site 15. Participant's lesion is a primary skin cancer 16. Participant's lesion is the manifestation of a metastasis
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hardy Schweigel, PhD | Contact | +491522 | 7752954 | hardy.schweigel@essity.com |
| Sandra Tobisch | Contact | sandra.tobisch@essity.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Niels Stensen Klinik, Christliches-Klinikum-Melle | Recruiting | Melle | Niedersachsten | 49624 | Germany |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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Two assessors are blinded to evaluate some outcomes
| up to 30 days |
| Occurrence clinical relevant peri-wound skin changes | Effect of product use on peri-wound skin such as reddening, swelling, clinical relevant skin detoriations | up to 30 days |
| Changes in wound tissue and general wound pain | Effect of product use on the wound considering wound tissue and slough on the wound as well as the general wound pain assessed using a 11 visual analogue scale from 0-10 (0= not pain, 10=most imaginable pain for the participant) | up to 30 days |
| Need for debridement after product removal | Evaluation of the soft debridement effect of Cutimed Sorbion products during dressing removal: is the soft debrimdent supporting wound cleansing and eases addtional wound debridement | up to 30 days |
| Patient satisfaction with treatment and product | Patient´s impressions about treatment and felt protection for leakage when using the product and assessment of individually felt wearing comfort | final study visit |
| HCP satisfaction with treatment and product | HCP´s satisfaction with treatment and product performance to manage wound exudate, check if treatment need have been met be the product | final study visit |
| Changes in quality of life using the "Wound-QoL 14" (short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments) | Fourteen items are scored using a Likert-type scale as either 'not at all', 'a little', 'moderately', 'quite a lot' or 'very much'. Item data are calculated building a global score and the 3 subscores "Body", "Psyche/Well-being" and the "Everyday life". In increase in quality of life is indicated by decreasing sub- and/or global score. | day 0 and day 30 |
| Mid Yorkshire Teaching NHS Trust Pinderfields Hospital | Recruiting | Wakefield | West Yorkshire | WF1 4DG | United Kingdom |
|
| Northumbria Healthcare NHS Foundation Trust | Recruiting | Ashington | NE63 0HP | United Kingdom |
|
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |