Prospective cohort study on surgical wounds comparing a polyhexanide-containing biocellulose dressing with a dialkyl-carbamoyl-chloride-containing hydrophobic dressing

Abstract

Objective: Postsurgery dressing changes in diabetic foot amputation wounds and surgical wounds healing by secondary intention are often conducted in the operating room under general anesthesia. A prospective comparative cohort study was performed in 60 patients (n = 60: n = 30/n = 30) with secondary-intention surgical wounds (82% had forefoot and/or digit[s] amputations) to compare 2 different dressing types.

Method: Patients at the study center gave informed written consent, after which they were randomly allocated to one of the treatment groups. Group A received a biocellulose dressing with polyhexanide, and group B a hydrophobic dressing with dialkyl-carbamoyl-chloride. In both groups, gauze was used as secondary dressing and fixed with a film dressing. One day after surgery, the dressings were removed by the surgeon and patient-reported pain and dressing adherence/integrity were evaluated. The number of patients that required general anesthesia was determined during the procedure and afterward.

Results: All patients (n = 60; n = 30/n = 30) were included in the intention-to-treat analysis. Pain levels in group A were significantly (t (59) = 4.026, P < .000) lower upon dressing removal, when compared with group B; in group A, n = 21 reported no pain versus n = 8 (26%) for group B. In group A, the dressing adhered in 7 subjects (23%) versus n = 27 (90%) of cases in group B (P = .000). No anesthesia was required for the patients in group A, contrary to group B, where 16% of patients received general anesthesia for dressing removal.

Conclusion: Pain levels were significantly lower and the dressing adhered significantly less in group A, compared with group B, demonstrating a better quality of life for the patients in group A.