Elsevier

Burns

Volume 37, Issue 5, August 2011, Pages 800-804
Burns

Randomized controlled single center study comparing a polyhexanide containing bio-cellulose dressing with silver sulfadiazine cream in partial-thickness dermal burns

https://doi.org/10.1016/j.burns.2011.01.027Get rights and content

Abstract

Objective

A prospective, randomized, controlled single center study was designed to evaluate clinical efficacy of a polyhexanide containing bio-cellulose dressing (group B) compared to a silver-sulfadiazine cream (group A) in sixty partial-thickness burn patients.

Patients and methods

Local ethics committee approval was obtained and patients consented. Parameters were: pain reduction (VAS), healing time and wound bed condition, comparing day 0 (start) versus day 14 (end), as well as, ease of dressing use and treatment costs.

Results

All completed the study (n = 30/n = 30) and were included in the ITT analysis, with a total of 72 burns (group A: n = 38, group B: n = 34). We noted no differences in healing time. Pain reduction was significantly faster and better in group B (p < 0.01). There were fewer dressing changes in group B, compared to group A. Ease of use for the bio-cellulose dressing was rated better compared to group A. In group B, € 95.20 was saved for a 10 day treatment period, compared to group A.

Conclusion

Group B demonstrated a better and faster pain reduction in the treated partial-thickness burns, compared to group A. The results indicate the polyhexanide containing bio-cellulose dressing to be a safe and cost effective treatment for partial-thickness burns.

Introduction

There is a need for more effective methods to relieve pain associated with burns, especially regarding discomfort observed during dressing changes [1], [2]. Not only is acute burn pain a source of suffering, but also it has been linked to debilitating chronic pain and stress-related disorders [1]. Dressing changes are reported to be one of the most painful and traumatic aspects of burn treatment [2]. During the last years new products for second degree burns have become available [3], [4]. One of the major advances of these alloplastic temporary wound covers is the reduced frequency of dressing changes, which results in overall pain reduction [5], [6]. Although alloplastics have advantages, they may not be suitable for burns located on e.g. fingers, throat, axilla, or in case of a post surgical infection [3], [4].

A polyhexanide containing bio-cellulose dressing (BWD + PHMB) is proposed as an option in these cases [9], [10], [11], [12], [13]. The biosynthetic cellulose dressing is hydrophilic and has the ability to both donate and absorb moisture depending on the wound bed condition [14]. It is synthesized by Acetobacter xylinum, and processed into a matrix material that is biocompatible [15]. The dressing is reported to have demonstrated faster healing and less pain than standard care [14], [16]. BWD has been shown in clinical studies to reduce pain, to support wound cleansing and to stimulate wound healing [14], [16]. The soothing effect may be attributed to the insulating properties of BWD providing a seal and protecting the wound with its synthetic blister roof [14], [16]. Such a seal protects the sensitive nerve endings and reduces major shifts in wound temperature. BWD may be combined with polyhexanide (BWD) to lower bacterial load [17], [18], [19]. PHMB is a cationic polymer that can be used for the treatment of local infections. PHMB products contain a surface-active substance (surfactant – a wetting agent that lowers the surface tension of a liquid), which can penetrate difficult coatings to stimulate wound healing [17], [18], [19]. Surface tension is the property of a liquid surface that acts like a stretched elastic membrane. The proposed mechanism of action of PHMB is based on its low surface tension, which supports the physical removal of debris and bacteria from the wound bed [9], [17], [18], [19]. In addition, its antimicrobial properties facilitate a reduction in microbial loads [18], [19]. PHMB has a broad spectrum of activity against Gram-positive and Gram-negative bacteria, fungi and biofilms [18], [19] and can be applied over a long period of time due to its low toxicity. PHMB has good tissue compatibility based on its activity against the acid lipids contained within the bacterial cell membranes and minor effect on the neutral lipids of human cell membranes [9], [10], [11], [12], [13], [14]. This helps to prevent damage to the surrounding healthy tissue [14]. PHMB has demonstrated efficacy in the management of non-healing chronic and/or refractory wounds (e.g. second degree burns), as well as for lavages [10], [14], [15], [16], [20].

It may also be an alternative to silver-sulfadiazine cream (SSD), which is commonly used in the treatment of superficial burns [1], [7]. There are concerns about the use of SSD for superficial burns, such as enhancing pro-inflammatory cytokines, prolonging inflammation, which may lead to poor scarring [21], [22], [23], [24]. Although SSD is still seen as a suitable dressing for superficial burns [24], [25] it has been long reported to have potentially serious side effects [26], [27], [28]. Further there have been reports on the successful use of cellulose dressings in superficial burns that showed benefits over SSD application [1], [2], [6].

The hypothesis was that partial thickness burns treated with BWD + PHMB would demonstrate equivalent healing time and better and faster pain reduction when compared to SSD dressings. A prospective, randomized, single-center clinical study was conducted to test this hypothesis.

Section snippets

Patients and methods

Ethical committee approval was granted before the start of the study. Sixty subjects with a mean age of 38 years (±14.96), suffering from seventy-two second-degree burns [2] were included in the study, after giving informed consent (Fig. 1).

The majority of patients were male (n = 39/60), most of them had scalds on their thighs (n = 26/72) or arms (n = 24/72). The mean wound size for the included patients was 147.4 cm2 (±101.9 cm2), in group A this was 151.2 cm2 (±109.6 cm2) and in group B 134.7 cm2 (±99 cm2

Results

Sixty patients (39 male) with seventy-two second-degree burns were included in the ITT analysis. Thirty-four wounds were allocated to group B (BWD + PHMB) whereas thirty-eight wounds were included in group A (SSD). The majority of burns were scalds (n = 33/72) mainly on the arms (n = 24) and on the thighs (n = 26). The median healing time for both group A and B was ten days. There was a significant faster and better pain reduction observed for patients treated with BWD + PHMB (p < 0.01, Wilcoxon signed

Discussion

Burns require a high standard of care to reach optimal healing results and to avoid hypertrophic scarring. One of the key points to achieve such a high standard is to be able to assess the wound accurately during treatment [29], [32]. Silver-sulfadiazine cream represents one of the current standards for the treatment of superficial burns [1], [7], [24], [25]. Apart from increasing resistance to silver, one of the main disadvantages of silver-sulfadiazine is the fact that judging the wound

Conclusion

The results of the present study showed an equal healing time for both group A and B. BWD + PHMB was shown to be safe and comfortable for the patients with a faster and significant better pain reduction than was shown in group A. Moreover the cost for 10 days treatment with BWD + PHMB lead to a reduction of € 95.20 per treated patient, compared to treatment with SSD. Based on the significant increase of patient comfort and cost savings, BWD + PHMB is proposed as a safe and effective treatment

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