A Bellingeri1, F Falciani2, P Traspedini3, A Moscatelli4, A Russo5, G Tino6, P Chiari7, A Peghetti8. 1. Wound Care Specialist Nurse, Head of Wound Care Department; I.r.c.c.s. Policlinico San Matteo, Pavia, Italy. 2. Wound Care Specialist Nurse, Coordinator Wound Care Department; Florence Hospital, Florence, Italy. 3. Wound Care Specialist Nurse; Di Circolo Hospital - Macchi Foundation, Varese, Italy. 4. Specialist Nurse, Professor of Nursing; Milan University, Milan, Italy. 5. Wound Care Specialist Nurse, Head of Nursing; S. Giovanni Hospital, Turin, Italy. 6. Wound Care Specialist Nurse, Coordinator Nursing Services; Sollievo della Sofferenza Hospital-San Giovanni Rotondo (FG), Italy. 7. Nurse, Researcher; Medical and Surgical Sciences, Bologna University, Bologna, Italy. 8. Wound Care Specialist Nurse; Solatrix Hospital, Rovereto (TN), Italy.
Abstract
OBJECTIVE: Research into surfactant solutions for the debridement of chronic wounds suggests that surfactants may support wound bed preparation (WBP) in chronic wounds, however their efficacy has not been evaluated in randomised controlled trials (RCTs). Our aim was to assess the clinical efficacy of a propylbetaine-polihexanide (PP) solution versus normal saline (NS) solution in WBP, assessing inflammatory signs and wound size reduction in patients with pressure ulcers (PUs) or vascular leg ulcers. METHOD: In a single-blinded randomised controlled trial (RCT) patients were randomly allocated to two groups and treated with either propylbetaine-polihexanide (PP) solution (Prontosan) or NS. Wounds were assessed using the Bates-Jensen wound assessment tool (BWAT). Assessments took place at inclusion (T0), day 7 (T1), day 14 (T2), day 21 (T3), and day 28 (T4). Outcomes were analysed using a two-tailed Student's t-test. RESULTS:A total of 289 patients were included. Both groups had similar demographics, clinical status, and wound characteristics. Data analysis showed statistically significant differences between T0 and T4 for the following outcomes: BWAT total score, p=0.0248; BWAT score for inflammatory items, p=0.03; BWAT scores for wound size reduction (p=0.049) and granulation tissue improvement (p=0.043), all in favour of PP. The assessment of pain did not show any significant difference between the two groups. CONCLUSION: The study results showed significantly higher efficacy of the PP solution versus NS solution, in reducing inflammatory signs and accelerating the healing of vascular leg ulcers and PUs. This evidence supports the update of protocols for the care of chronic wounds. DECLARATION OF INTEREST: The authors have no conflict of interest regarding this research. This is an investigator initiated trial. B. Braun Milano SpA kindly provided the material under investigation for both treatment groups, and paid the Ethics Committees' application fees in all participating centres.
RCT Entities:
OBJECTIVE: Research into surfactant solutions for the debridement of chronic wounds suggests that surfactants may support wound bed preparation (WBP) in chronic wounds, however their efficacy has not been evaluated in randomised controlled trials (RCTs). Our aim was to assess the clinical efficacy of a propylbetaine-polihexanide (PP) solution versus normal saline (NS) solution in WBP, assessing inflammatory signs and wound size reduction in patients with pressure ulcers (PUs) or vascular leg ulcers. METHOD: In a single-blinded randomised controlled trial (RCT) patients were randomly allocated to two groups and treated with either propylbetaine-polihexanide (PP) solution (Prontosan) or NS. Wounds were assessed using the Bates-Jensen wound assessment tool (BWAT). Assessments took place at inclusion (T0), day 7 (T1), day 14 (T2), day 21 (T3), and day 28 (T4). Outcomes were analysed using a two-tailed Student's t-test. RESULTS: A total of 289 patients were included. Both groups had similar demographics, clinical status, and wound characteristics. Data analysis showed statistically significant differences between T0 and T4 for the following outcomes: BWAT total score, p=0.0248; BWAT score for inflammatory items, p=0.03; BWAT scores for wound size reduction (p=0.049) and granulation tissue improvement (p=0.043), all in favour of PP. The assessment of pain did not show any significant difference between the two groups. CONCLUSION: The study results showed significantly higher efficacy of the PP solution versus NS solution, in reducing inflammatory signs and accelerating the healing of vascular leg ulcers and PUs. This evidence supports the update of protocols for the care of chronic wounds. DECLARATION OF INTEREST: The authors have no conflict of interest regarding this research. This is an investigator initiated trial. B. Braun Milano SpA kindly provided the material under investigation for both treatment groups, and paid the Ethics Committees' application fees in all participating centres.
Entities:
Keywords:
inflammation; leg ulcers; polihexanide; pressure ulcers; propylbetaine; wound debridement
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