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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
152
Cutimed Sorbion or Zetuvit plus (RespoSorb) application to maintain wound exudate
Niels Stensen Klinik, Christliches-Klinikum-Melle
Melle, Niedersachsten, Germany
RECRUITINGMid Yorkshire Teaching NHS Trust Pinderfields Hospital
Wakefield, West Yorkshire, United Kingdom
RECRUITINGNorthumbria Healthcare NHS Foundation Trust
Ashington, United Kingdom
RECRUITINGExudate management performance
Capability to main exudate uptake and retention as well as leakage prevention
Time frame: up to 30 days
Dressing change frequency
Number of required intermediate dressing changes between study visits and assessement fo reasons for
Time frame: up to 30 days
Moisture-associated skin damages
Occurrence of moisture-associated skin damages
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: day 0 and day 30
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