Effect of a wound cleansing solution on wound bed preparation and inflammation in chronic wounds

a single-blind RCT

A Bellingeri, F. Falciani, P Traspedini, A Moscatelli, A Russo, G Tino, P. Chiari, Angela Peghetti

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)160, 162-6, 168
JournalJournal of wound care
Volume25
Issue number3
DOIs
Publication statusPublished - Mar 2016

Fingerprint

Randomized Controlled Trials
Inflammation
Wounds and Injuries
Leg Ulcer
Pressure Ulcer
Sodium Chloride
Surface-Active Agents
Blood Vessels
Conflict of Interest
Ethics Committees
Fees and Charges
Granulation Tissue
Debridement
Pain Measurement
Research
Research Personnel
Demography
Students
Vantocil

Keywords

  • Aged
  • Aged, 80 and over
  • Bandages
  • Betaine
  • Biguanides
  • Chronic Disease
  • Female
  • Humans
  • Inflammation
  • Male
  • Middle Aged
  • Pressure Ulcer
  • Single-Blind Method
  • Sodium Chloride
  • Solutions
  • Therapeutic Irrigation
  • Varicose Ulcer
  • Wounds and Injuries
  • Journal Article
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

Cite this

Effect of a wound cleansing solution on wound bed preparation and inflammation in chronic wounds : a single-blind RCT. / Bellingeri, A; Falciani, F.; Traspedini, P; Moscatelli, A; Russo, A; Tino, G; Chiari, P.; Peghetti, Angela.

In: Journal of wound care, Vol. 25, No. 3, 03.2016, p. 160, 162-6, 168.

Research output: Contribution to journalArticle

Bellingeri, A ; Falciani, F. ; Traspedini, P ; Moscatelli, A ; Russo, A ; Tino, G ; Chiari, P. ; Peghetti, Angela. / Effect of a wound cleansing solution on wound bed preparation and inflammation in chronic wounds : a single-blind RCT. In: Journal of wound care. 2016 ; Vol. 25, No. 3. pp. 160, 162-6, 168.
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T2 - a single-blind RCT

AU - Bellingeri, A

AU - Falciani, F.

AU - Traspedini, P

AU - Moscatelli, A

AU - Russo, A

AU - Tino, G

AU - Chiari, P.

AU - Peghetti, Angela

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N2 - 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.

AB - 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.

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KW - Aged, 80 and over

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KW - Betaine

KW - Biguanides

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KW - Humans

KW - Inflammation

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KW - Middle Aged

KW - Pressure Ulcer

KW - Single-Blind Method

KW - Sodium Chloride

KW - Solutions

KW - Therapeutic Irrigation

KW - Varicose Ulcer

KW - Wounds and Injuries

KW - Journal Article

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

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JO - Journal of wound care

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SN - 0969-0700

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