Open, non-comparative, multi-centre post clinical study of the performance and safety of a gelling fibre wound dressing on diabetic foot ulcers.

OBJECTIVE

To evaluate the performance and safety of Exufiber, a gelling fibre wound dressing incorporating Hydrolock technology, in the management of highly exuding diabetic foot ulcers (DFUs).

METHOD

The study was conducted over a 12 week period involving a total of 21 patients with DFUs. A number of parameters were measured to monitor the change in condition of the peri-wound skin from baseline assessments. The evaluation of dressing-related pain was measured using a 100mm visual analogue scale (VAS). Wound status (measured by changes in wound size and healing phase) was recorded. Clinician/patient opinions of the test product and technical performance (measured by the presence of dressing residue following removal and handling of wound exudate) were also recorded.

RESULTS

The number of patients with healthy/intact peri-wound skin increased from baseline to the final visit. There was also a steady decrease in wound exudate volume throughout the study. Pain levels were very low throughout the investigation period, bearing in mind issues with neuropathy. A gradual decline in all wound size parameters from baseline to the final visit was noted; there was a statistically significant reduction in both wound area (cm(2)), p=0.0094, and wound volume (cc), p=0.0056, from baseline to the final visit. Throughout the study, a small decline in the mean percentage of granulation tissue within the wound paralleled a gradual increase in the mean percentage of epithelialisation tissue, while the percentage of non-viable tissue remained very low. The primary endpoints of product performance and safety were measured by the changes from baseline in the condition of the peri-wound skin. Results showed that the number of patients with healthy/intact peri-wound skin increased from baseline to the final visit, increasing from 6 patients (28.6%) at baseline to 14 patients (66.7%) at the final visit. There were no occurrences of product degradation on the skin and no reported adverse events (AE)/adverse device effects (ADE) during the course of the study that were judged to be related to the investigational product.

CONCLUSION

This study has demonstrated the capacity for the test dressing to minimise damage to the peri-wound skin and dressing-associated pain. Despite the majority of wounds remaining unhealed at the final visit, improvements were noted in terms of tissue type and a significant reduction in wound area and volume. The technical performance of the dressing was demonstrated by an ability to absorb and retain exudate. Product safety was also demonstrated by an increase in the number of patients with healthy/intact peri-wound skin and the lack of identified product-related AE/ADEs.

DECLARATION OF INTEREST

The study was supported by an unrestricted educational grant from Mölnlycke Health Care.