Exufiber in practice

• Foot ulceration in diabetic patients is difficult to manage.
• Patients whose diabetes is poorly managed are at an increased risk of foot ulceration and foot amputation.
• Dressing selection is one important aspect of diabetic foot ulcer (DFU) management.
• DFUs are associated with medical costs, as well as personal, social and economic costs.
• Like other chronic wounds, DFUs may produce excessive levels of exudate; as a result, the periwound skin is at risk of maceration.

• To evaluate the performance and safety of Exufiber^®, a gelling fiber wound dressing, in the management of DFUs.

• This was an open, non-comparative multi-center investigation.
• Both inpatient and outpatient were eligible.
• Patients with more than one ulcer were eligible for inclusion into the investigation, however only one ulcer per patient was included in the investigation.
• Each patient was managed according to the local clinical protocol and all dressings were applied according to the manufacturer’s instructions.
• Patients participated in the investigation until complete wound healing or if the wound became dry (whereby the test product was no longer applicable) or for 12 weeks, whichever occurred first.
• Patients were assessed at baseline and again at weeks 1, 2, 4, 6, 8 and 12 post-treatment.
• Dressing changes were performed according to the local clinical protocols; (usually 3 times per week) when the dressing was saturated. Depending on the status and location of the wound, dressing changes between visits were allowed.
• At each assessment visit, the following variables were assessed:
  -  Wound size, volume (using the Pictzar program) and depth at the deepest point of the wound (using a q-tip); measurements made every fourth week and an additional measurement at week 6)
  -  Appearance of ulcer bed o Condition of peri-wound skin
  -  Technical performance o Amount and type of wound exudate
  -  Need for debridement o Adverse events (AEs)/adverse device effects (ADEs)
  -  Pain (before removal of the secondary dressing; before removal of the test product; during removal of the test product; after removal of the test product). Some patients were not eligible for inclusion in the pain assessment due to neuropathy
  -  Clinical signs of infection

Primary study objective:
 -  To evaluate the performance and safety of Exufiber when used as intended on DFUs.
 -  In line with this objective, a number of evaluation parameters were measured to monitor the condition of the peri-wound skin (evaluated in terms of changes from baseline assessments): maceration; redness/irritation; rash/eczema; blistering; dermatitis; skin stripping; trauma to the wound edges; product degradation on the skin.

Secondary study objective:
 -  Evaluation of dressing-related pain (measured using a 100mm visual analogue scale (VAS)).
 -  Wound status (measured by changes in wound size and healing phase). 
 -   Clinician/patient opinions of the test product.
 -  Technical performance of the test product (measured by the presence of dressing residue following removal and handling of wound exudate).

• The results from this study have demonstrated the ability of the investigational wound dressing to minimize damage to the peri-wound skin and dressing-associated pain.
• Although most wounds remained unhealed at the end of the study period, improvements were noted in terms of tissue type and a significant reduction in wound area and volume.
• The dressing’s technical performance was demonstrated by an ability to absorb and retain exudate.
• Product safety was demonstrated by an increase in the number of patients with healthy/intact periwound skin and the lack of identified productrelated AEs/ADEs.