Efficacy of Conventional and Liposomal Povidone-Iodine in Infected Mesh Skin Grafts : An Exploratory Study
INTRODUCTION: Infection is a major threat to wound healing and a leading cause of graft loss in patients undergoing meshed skin grafts (MSGs). Therefore, topical antisepsis is important in the overall treatment scheme.
METHODS: An exploratory satellite group of 14 patients with infected MSGs were enrolled as part of a prospective, randomized, controlled, parallel-group, open-label, pilot Phase II study that investigated the efficacy and tolerability of 3% liposomal povidone-iodine hydrogel (PVP-ILH, Repithel®; RepiGel®) versus chlorhexidine gauze in non-infected MSGs. The satellite group included both patients with infected wound beds prior to grafting and patients with infection of a previously placed graft, with MSG sizes ranging from 50 to 1000 cm2, who were randomized to treatment with (PVP-ILH) or 10% povidone-iodine ointment (Betaisodona®; BETADINE®). Medication was applied in a 2-mm layer and dressing changes with identical application of study medication took place daily. Wounds were evaluated by photoplanimetry, microbiologically and subjectively by patients and physicians.
RESULTS: The results for the main study group have been reported previously. In the satellite group, both PVP-ILH and povidone-iodine ointment performed remarkably well with respect to lowering the bacterial count and restoring wound healing, with different emphasis. Povidone-iodine ointment showed excellent antibacterial efficacy with no detectable microorganisms by Day 10, and rapid re-epithelialization (mean 90% by Day 6). PVP-ILH also demonstrated rapid re-epithelialization (mean 72% by Day 6) with a trend towards improved subjective measures of wound healing quality. Four patients (40%) receiving PVP-ILH experienced partial graft loss (10-15% of total MSG area); no patients in the povidone-iodine ointment group experienced graft loss.
CONCLUSION: Our results suggest that povidone-iodine ointment has a strong role in managing infected wounds, especially when a high concentration of povidone-iodine may be warranted, while PVP-ILH indicated similar beneficial results on markers of wound healing quality in larger infected wounds.
TRIAL REGISTRATION: The trial was conducted prior to mandatory registration of drug products, PVP-ILH represents a medicated device in the EU and many other countries.
FUNDING: Mundipharma Research GmbH & Co. KG.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2017 |
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| Erschienen: |
2017 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:6 |
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| Enthalten in: |
Infectious diseases and therapy - 6(2017), 4 vom: 10. Dez., Seite 545-555 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Vogt, Peter M [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Revised 01.10.2020 published: Print-Electronic Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1007/s40121-017-0172-z |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM276881591 |
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| 100 | 1 | |a Vogt, Peter M |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy of Conventional and Liposomal Povidone-Iodine in Infected Mesh Skin Grafts |b An Exploratory Study |
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| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a INTRODUCTION: Infection is a major threat to wound healing and a leading cause of graft loss in patients undergoing meshed skin grafts (MSGs). Therefore, topical antisepsis is important in the overall treatment scheme | ||
| 520 | |a METHODS: An exploratory satellite group of 14 patients with infected MSGs were enrolled as part of a prospective, randomized, controlled, parallel-group, open-label, pilot Phase II study that investigated the efficacy and tolerability of 3% liposomal povidone-iodine hydrogel (PVP-ILH, Repithel®; RepiGel®) versus chlorhexidine gauze in non-infected MSGs. The satellite group included both patients with infected wound beds prior to grafting and patients with infection of a previously placed graft, with MSG sizes ranging from 50 to 1000 cm2, who were randomized to treatment with (PVP-ILH) or 10% povidone-iodine ointment (Betaisodona®; BETADINE®). Medication was applied in a 2-mm layer and dressing changes with identical application of study medication took place daily. Wounds were evaluated by photoplanimetry, microbiologically and subjectively by patients and physicians | ||
| 520 | |a RESULTS: The results for the main study group have been reported previously. In the satellite group, both PVP-ILH and povidone-iodine ointment performed remarkably well with respect to lowering the bacterial count and restoring wound healing, with different emphasis. Povidone-iodine ointment showed excellent antibacterial efficacy with no detectable microorganisms by Day 10, and rapid re-epithelialization (mean 90% by Day 6). PVP-ILH also demonstrated rapid re-epithelialization (mean 72% by Day 6) with a trend towards improved subjective measures of wound healing quality. Four patients (40%) receiving PVP-ILH experienced partial graft loss (10-15% of total MSG area); no patients in the povidone-iodine ointment group experienced graft loss | ||
| 520 | |a CONCLUSION: Our results suggest that povidone-iodine ointment has a strong role in managing infected wounds, especially when a high concentration of povidone-iodine may be warranted, while PVP-ILH indicated similar beneficial results on markers of wound healing quality in larger infected wounds | ||
| 520 | |a TRIAL REGISTRATION: The trial was conducted prior to mandatory registration of drug products, PVP-ILH represents a medicated device in the EU and many other countries | ||
| 520 | |a FUNDING: Mundipharma Research GmbH & Co. KG | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Liposomal povidone–iodine hydrogel | |
| 650 | 4 | |a Mesh skin grafts | |
| 650 | 4 | |a Microbial colonization | |
| 650 | 4 | |a Povidone–iodine ointment | |
| 650 | 4 | |a Pseudomonas aeruginosa | |
| 650 | 4 | |a Staphylococcus aureus | |
| 650 | 4 | |a Topical antisepsis | |
| 650 | 4 | |a Wound healing | |
| 650 | 4 | |a Wound infection | |
| 700 | 1 | |a Hauser, Joerg |e verfasserin |4 aut | |
| 700 | 1 | |a Mueller, Stefan |e verfasserin |4 aut | |
| 700 | 1 | |a Bosse, Bjoern |e verfasserin |4 aut | |
| 700 | 1 | |a Hopp, Michael |e verfasserin |4 aut | |
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