Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.

Published evidence

Six studies including 833 people are summarised in this briefing.

The included studies are:

  • a single-blind randomised controlled trial comparing Prontosan and saline in vascular leg ulcers and pressure ulcers

  • a single-blind prospective controlled trial comparing Prontosan and saline in venous leg ulcers

  • a retrospective review of data on the use of the Prontosan range in children with burns

  • an observational study describing the use of Prontosan solution to debride chronic wounds

  • a multicentre observational study on the use of Prontosan in people of all ages with chronic wounds

  • a retrospective record review comparing Prontosan with saline and Ringers solution.

There are other studies published on Prontosan that have not been reviewed in this briefing. The 6 most relevant studies for the NHS have been selected.

The clinical evidence, and its strengths and limitations, is summarised in the overall assessment of the evidence.

Overall assessment of the evidence

The 3 comparative studies showed that using Prontosan could improve chronic wound healing. One of these studies reported improved pain scores and wound odour control for Prontosan compared with saline solution. Another of the studies followed wounds for 6 months and recorded total healing in most wounds. In this study wounds that were treated with Prontosan healed significantly more quickly.

Bellingeri et al. (2016)

Intervention and comparator(s)

Prontosan solution and saline.

Key outcomes

Wounds were assessed using the Bates-Jensen wound assessment tool (BWAT) on day 0, day 7, day 14, day 21 and day 28. Outcomes were analysed using a 2‑tailed student's t‑test. There were statistically significant improvements in outcomes for wounds cleansed with Prontosan between day 0 and day 28: BWAT total score, p=0.0248; BWAT inflammation, p=0.03; BWAT wound size reduction, p=0.049; and granulation tissue improvement, p=0.43. There was no significant difference in pain between the 2 groups.

Strengths and limitations

The study participants had a mixed aetiology of chronic wounds; however, they were similar in terms of demographics, clinical status and wound characteristics.

Romanelli et al. (2010)

Intervention and comparator(s)

Prontosan solution and saline. Both groups also had standard wound care of polyurethane foam and compression bandaging.

Key outcomes

Baseline pH on the wound surface (median range) in both groups was 8.9 (range 0.6). After 4 weeks of treatment, wound surface pH was 7.0 (range 0.3) in the Prontosan group. This was significantly lower (p<0.05) than the wound surface pH in the saline group in week 4. There was no significant reduction in wound size from baseline to the end of the study period in either of the groups. Patient-reported visual analogue scale pain scores were significantly improved (p<0.05) in the Prontosan group in week 4 of treatment. The authors also noted that wound odour was better controlled in the Prontosan group and that bacterial burden was lower.

Strengths and limitations

The study was partially funded by the company, and one of the authors has received payment for clinical consultation. The people included in each arm of the study had no statistically significant differences in age, mean disease duration, mean wound size or pain score at the start of the study. The study follow up was only 4 weeks, which is unlikely to be long enough to show any differences in wound healing. The study results are presented in graphs only; however, it seems the differences between the 2 groups were not significant until week 4 of the study.

Ciprandi et al. (2018)

Study size, design and location

198 children with burns in a retrospective data review. Location: UK, Italy, Russia, Germany and Belgium.

Intervention and comparator(s)

Prontosan solution and gels, no comparator.

Key outcomes

The data review was intended to collect data on the safety of using the Prontosan range on children with burns in routine clinical practice. Of the 198 records reviewed, adverse events were reported in 5 children (3 cases of itching, 1 rash and 1 case of hypergranulating tissue). All adverse events resolved and healed well. No severe adverse events were recorded. 11 children (5.5%) developed clinical signs of infection, which was mostly found to be Staphylococcus aureus when tested.

Strengths and limitations

Because this study is not comparative it is not possible to draw any conclusions about whether Prontosan is more effective than other treatments for burn wound cleansing and moistening. However, because 80% of the children included in the study were under 4 years old, this study provides useful safety data for a patient population less reported on in research.

Ricci (2018)

Study size, design and location

70 people with chronic wounds (older than 6 weeks) in an observational study. Location: Italy.

Intervention and comparator(s)

Prontosan solution; treatment was given in 2 regimens: group A (40 people) was treated with a single application of Prontosan for different time durations (2, 5, 10 and 15 minutes) and group B (30 people) was treated with Prontosan for 10 minutes, daily, during dressing changes for 14 days.

Key outcomes

In group A, there were no changes after the 2‑minute and 5‑minute applications. At 10 minutes there was improvement in 4 out of 10 wounds and at 15 minutes there was improvement in 5 out of 10 wounds. In group B, after 14 days of treatment, 73% of wounds were cleaned and debrided. People in group B reported a reduction in pain. Peri-wound skin was improved in 29 out of 30 people in group B. One person in group B had tissue deterioration due to maceration.

Strengths and limitations

Because this study is not comparative it is not possible to draw any conclusions about whether Prontosan is more effective than other treatments for debriding chronic wounds. It is not clear what types of chronic wounds were included in the study. The follow-up period of 14 days is not long enough to show the effect of Prontosan on wound healing. However, it should be noted that all wounds had been present for 6 weeks before the study, and had not responded to standard treatment in this time. The study results suggest that Prontosan should be applied for at least 10 minutes to effectively remove residue and debride chronic wounds.

Durante et al. (2014)

Intervention and comparator(s)

Prontosan wound gel, no comparator.

Key outcomes

Wound size and pain decreased significantly (p<0.001) from baseline to the end of the study. Wound size decreased in length (-17.5; range 21.4 cm), width (-15.5; range 21.1 cm) and area (-8.3; range 16.7 cm2). Pain in adults was measured using the visual analogue scale, and reduced by -4.67 (range 2.7). In children under 3 years the face, legs, activity, cry, consolability scale was used, which changed by less than 1 (range 4). Overall, 90% of wounds reduced in size and 80% of people reported a reduction in pain compared with the baseline visit. 75% of wounds reached complete skin integrity by the end of the study. Exudate also reduced: at the baseline visit 15% of wounds had no exudate, and this increased to 74% by the end of the study. The authors also noted that dressing changes were required less frequently at the final visit compared with the baseline visit.

Strengths and limitations

Because this study is not comparative it is not possible to draw any conclusions about whether Prontosan is more effective than other treatments for chronic wounds. The reported reductions in wound size have very large standard errors, which do not seem to support the statistical significance reported. The study recruited people of all ages (from 4 days to 91 years old) with mixed wound aetiology, which may have contributed to the uncertainty in the results.

Andriessena and Eberlein (2008)

Study size, design and location

112 adults with venous leg ulcers in a retrospective review of records. Location: Netherlands.

Intervention and comparator(s)

Prontosan solution compared with saline or Ringers solution.

Key outcomes

The wounds treated with Prontosan had a higher chance of completely healing after 6 months (97% compared with 89%), and mean time to healing was significantly faster in the Prontosan group (3.31 months compared with 4.42 months; p<0.0001). There were fewer infections in the Prontosan group (2 out of 59 [3%]) than in the control group (7 out of 53 [13%]). The authors noted that wound cleansing with Prontosan was more effective than wound cleansing with saline or Ringers solution and that it improved the condition of the local wound environment.

Strengths and limitations

This study followed patient records for 6 months, which was long enough to observe the total healing of most included wounds. The authors noted that all people included in the study also received standardised compression therapy using bandaging to improve venous flow, speeding up wound healing.

Sustainability

The company claims that using Prontosan will reduce the number of dressings and nurse visits needed because of faster healing. The containers, shipping carton and cardboard packing that contain the gel can be recycled. There is no published evidence to support these claims.

Recent and ongoing studies

None.