4 Committee discussion

Clinical effectiveness overview

Prontosan shows promise but there is not enough evidence of its clinical benefit

4.1 The committee noted that much of the evidence comparing Prontosan and saline in chronic wounds was of low quality and at high risk of bias. The committee noted that there was very limited evidence for acute wounds. The committee agreed that the technology showed promise based on clinical expert advice, but that this was not supported by the evidence. The committee concluded that that there was not enough good quality evidence to make a clear judgement about the benefits of Prontosan compared with saline or water.

The evidence is heterogeneous in terms of wound type

4.2 The committee noted that the patient populations in the evidence were heterogeneous, including different wound types such as venous leg ulcers, chronic wounds of mixed aetiology, burns and surgical site wounds. The clinical experts agreed that Prontosan could be used for a broad patient population with acute or chronic wounds, although the committee considered that there was not enough clinical or cost evidence to make a judgement on its use in acute wounds. The committee understood that there is a diversity of wound type in the chronic wound population. It considered it difficult to generalise the evidence from trials, which included relatively narrow subgroups of this population (for example, pressure ulcers, arterial leg ulcers, venous leg ulcers, among others), to the total population with chronic wounds.

The evidence is heterogeneous in terms of how Prontosan was used

4.3 The committee noted that how Prontosan products were used ranged across the studies. Prontosan solution was used alone, with the gel or gel X, or the gel or gel X was used alone. The clinical experts agreed that the solution is used to irrigate and clean acute wounds (when clinically necessary) and can also be used as a soak for chronic wounds. The clinical experts noted that the gel is used less often, and always in combination with the solution to support and maintain the soak process. The clinical experts said the gel is most often used for more complex and chronic wounds and for people with a history of recurrent infections. The committee recognised the heterogeneity in the way the Prontosan products were used and concluded that this makes it difficult to draw conclusions about the evidence.

Side effects and adverse events

Prontosan has plausible benefits

4.4 The clinical experts noted that, in their experience, using Prontosan on static (non-healing) chronic wounds with a dull brown colour causes the wound bed to change to vibrant red granulated tissue (tissue in the process of healing). No adverse events or allergic or instant reactions to Prontosan were observed by the clinical experts. The clinical experts said that Prontosan is easy to use, soothing and does not sting. The committee recognised that pain is an important consideration when treating chronic and acute wounds and concluded that Prontosan has plausible benefits.

Outcome measures

Complete wound healing is the preferred outcome

4.5 The clinical experts said that Prontosan should be used until wounds are healed, or close to healing, and not just until the wound bed condition is improved. The clinical experts clarified that wounds can epithelialise (when a layer of new tissue forms over the wound) and close, but this does not mean the wound is healed. For people with a history of recurrent infection the wound can break down again if treatment is stopped before the wound is healed. Some types of chronic wounds, specifically leg ulcers, often deteriorate and recur. Chronic wounds can be complex and may become static or have high levels of recurrence. The clinical experts noted that some patients have wounds for 2, 3 or even 4 years. To measure Prontosan's effectiveness compared with saline, the committee concluded that evidence is needed that follows wounds until they are completely healed. This evidence should also measure the time it takes for complete healing to happen.

Uncertainties in the reporting of the BWAT score from Bellingeri 2016

4.6 The most robust evidence (a randomised controlled trial by Bellingeri 2016) was at low risk of bias but underpowered and showed a significant reduction in Bates-Jensen wound assessment tool (BWAT) score for Prontosan compared with saline. The EAC noted that it is unclear from the study whether all 13 dimensions of the tool were used. It was not confident that a reported BWAT score of 13 or 14 in this paper can be interpreted as wounds that have healed, or that are approaching healing.

Relevance to the NHS

The evidence from Bellingeri 2016 may not be generalisable to NHS clinical practice

4.7 In both the Prontosan and control (saline) groups of Bellingeri 2016, the protocol included irrigation (20 ml to 30 ml) followed by a 10-minute soak. There are no clear guidelines for cleansing wounds and the clinical experts said that the decision to irrigate or cleanse the wound lies with the assessing clinician. This decision depends on the condition of the wound and the person's risk factors and environment. The clinical experts also suggested that soaking with saline is not routinely done in the NHS. Although the protocol in Bellingeri 2016 makes it easier to understand trial outcomes, the committee recognised that it may not reflect the variability in care in NHS clinical practice.

NHS considerations overview

Prontosan does not add to the appointment time if the soak is applied at the start of the appointment

4.8 The clinical experts told the committee that Prontosan solution is often applied as a soak (for 10 to 15 minutes) for chronic wounds. The experts noted that this can lead to an increase in appointment times in some cases (primarily wound clinics) but that if the tasks are switched around and the soak is applied at the start of the appointment this should not extend the appointment time. The committee concluded that some education and training may be needed to ensure healthcare professionals know to soak with Prontosan solution at the start of an appointment.

Prontosan is part of a wound care package so the treatment effect is hard to establish

4.9 The committee noted that Prontosan is part of a wound care package and not used on its own. This means it is difficult to isolate the treatment effect of Prontosan on chronic wounds. The clinical experts stressed the importance of using a locally agreed wound care pathway and explained that treatments are selected using a holistic approach and clinician experience. People with chronic wounds do not necessarily see the same clinician, and use of products and dressings can vary between visits based on what is available. One clinical expert said it would be easier to use one solution consistently rather than decide between multiple solutions (water, saline or Prontosan). The committee concluded that it is hard to isolate the direct effect of Prontosan and recognised the need for an appropriate wound care pathway for chronic wounds.

Cost modelling overview

The cost models are acceptable but any cost modelling using the available evidence is likely to be flawed

4.10 The committee agreed that the clinical and cost case were dependent on each other. Prontosan would result in cost savings even if there was only a small benefit in healing rate or reduction in infection rate. The clinical inputs in the model were of low quality and at high risk of bias and subject to the same uncertainty as discussed in the clinical evidence section. It concluded that more research was needed to establish the clinical and cost benefits of using Prontosan in the NHS. Until then, any cost modelling is likely to be flawed.

Further research

Randomised controlled trials comparing Prontosan solution with saline or water in the NHS are needed

4.11 The committee concluded that research is needed to address the uncertainties about the clinical effectiveness of Prontosan wound irrigation solution compared with saline or water. It recommended that randomised controlled trials should be done in the NHS. These should compare Prontosan solution with saline or water in different types of chronic wounds. The randomised controlled trial needs to be well designed to detect clinically meaningful results in subgroups (for example, pressure ulcers or venous leg ulcers). The committee agreed that a key outcome should be time to complete wound healing. Other important outcomes should include pain and wound odour, measured using patient-reported outcome measures (PROMs). The number of dressing changes should also be recorded for each wound included in the study.

Real-world observational studies in the NHS are encouraged

4.12 The committee considered the low number of patients in the existing evidence and encouraged real-world observational studies. Real-world data collected from large cohorts would be helpful to understand differences in wound care in the NHS, including how different types of wounds are treated and how Prontosan would be used. For example, when using Prontosan solution and gel together would be clinically needed, and the effect of using Prontosan solution and gel together. Outcomes such as pain and wound odour should be measured using PROMs.

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Prontosan for acute and chronic wounds