Pilot-study switchable film dressing & NPWT: A non-interventional, non-placebo-controlled, national pilot study

Abstract

Aim

Negative pressure wound therapy (NPWT) has become an accepted treatment modality for acute and chronic wounds with accelerated healing rates observed. To prevent air from being sucked in from the external environment, the wound and the filler that rests inside or upon the wound are hermetically sealed with an airtight adhesive polyurethane drape that is permeable to water vapour, transparent, and bacteria proof [1]. During the removal of the dressing skin stress occurs. An essential role is shearing force between skin and wound dressing playing [7]. This problem includes missing elasticity, flexibility and to strong adhesion [7,8]. The present study was initiated to evaluate if the switchable formulation of the adhesive ensures a durable and effective occlusion of the dressing and function of the NPWT, but also that the defined adhesion is in the range of patient- and user satisfaction.

Methods

The used film dressing consists of a thin film backing with a non‑latex adhesive. Before removal the adhesion is reduced by illuminating the dressing with the UV-A lamp.

Results

50 patients at a mean age of 71.7 years (SD ± 12.0) with a total of 51 wounds (one patient had two wounds) were included in the study. Wound bed condition (multiple answers possible) was rated as granulation (47), sloughy (33) and necrotic tissue (3). Wound bed condition had improved during the short course of the study with a reduction of sloughy and necrotic tissue.

Wound pain/adjacent to the wound pain was specified with a mean of 3,44 (SD ± 1,4) on the VAS (0 = no pain, 10 = excruciating pain) and was decreasing to a mean of 2,3 (SD ± 1,2) at the final visit (see Table 2 and Fig. 2). The application of the dressing/occlusion with the dressing was rated in mean with 1,02 (1. Visit) and 1,00 (2. Visit) on the 6–point-scale (1 = very good – 6 = insufficient). Significance was calculated as 0,000 for visit 1 (one sample t-test [test value=3,0]). Reactions on the wound edge/wound surroundings have not been reported. In contrast, a reduction of maceration, redness and dryness of the wound edge/wound surrounding was observed (see Table 1).

Discussion

The clinicians gave favourable scores for the tested film dressing regarding application of the dressing, application of NPWT/connection with the suction, overall satisfaction with the application, tightness of the dressing since the last dressing change, easiness of illuminating the dressing with the UV-A lamp and removal of the dressing after illumination with the UV-A lamp. The overall satisfaction with the product was rated very good. Tolerability such as pain during wearing the dressing and upon removal were given good scores. Existing wound edge and wound surroundings findings like maceration, redness etc. at visit 1 decreased. Skin irritation caused in the use of the film dressing did not occur.

Conclusion

The results confirm that the adhesive ensures a safe and effective occlusion of the dressing and that the strong adhesion enables the NPWT to function according to specification.

The switchable function of the adhesive allows the adhesion of the film dressing to the skin to be reduced when illuminated by the supplied UV-A lamp. The results of the present study show that the reduced adhesion upon illumination enables easy and comfortable removal of the dressing.