PMID- 32743789
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240329
IS  - 2193-8210 (Print)
IS  - 2190-9172 (Electronic)
VI  - 10
IP  - 5
DP  - 2020 Oct
TI  - Evaluation of BepanGel Hydrogel Efficacy and Tolerability Using an Abrasive Wound 
      Model in a Within-Person, Single-Center, Randomized, Investigator-Blind Clinical 
      Investigation.
PG  - 1075-1088
LID - 10.1007/s13555-020-00432-5 [doi]
AB  - INTRODUCTION: Over the last few years, it has been demonstrated that a moist 
      environment enhances the healing process and reduces scar formation of wounds. 
      Such moist conditions can be created and maintained using hydrogels. The aim of 
      this study was to evaluate wound healing, cooling efficacy, local tolerability, 
      and cosmetic appearance of abrasive wounds treated with BepanGel wound care 
      hydrogel. METHODS: This study was designed as a within-person, single-center, 
      randomized, investigator-blind clinical investigation comparing a 
      hydrogel-treated test field with an untreated test field in an abrasive wound 
      model. In 33 subjects, two small superficial wounds were induced on the 
      non-dominant forearms. Wounds were treated with BepanGel and covered with a 
      standard semi-occlusive wound plaster or covered with a plaster alone for 
      11 consecutive days. Wound healing efficacy, cooling effect, and tolerability of 
      the treatment were assessed over 12 investigational days. During follow-up at 
      day 31, the cosmetic appearance of the wounds was evaluated. RESULTS: On day 12, 
      the test field treated with BepanGel was completely healed in nearly all subjects 
      (97.0%) in contrast with the test field treated with a plaster alone (18.2%, 
      AUC(days 2-12) p < 0.0001) as assessed by a blinded investigator. Two-thirds of 
      the unblinded subjects indicated an immediate cooling effect of the hydrogel 
      (p = 0.0555). At the end of the investigation, the cosmetic appearance of the 
      BepanGel-treated test fields scored superior to the fields treated with a plaster 
      alone as evaluated by a blinded investigator (p = 0.0005) and the unblinded 
      subjects (p = 0.0078). The hydrogel was generally well tolerated and no signs of 
      infection or adverse events (AEs) related to the treatment were observed. 
      CONCLUSION: This evaluation shows that treatment of superficial cutaneous wounds 
      with BepanGel results in improved wound healing as demonstrated by faster wound 
      closure and a considerably better cosmetic appearance, while providing immediate 
      cooling. TRIAL REGISTRATION NUMBER: EUDAMED-No.: CIV-19-09-029744.
FAU - Zhang, Lei
AU  - Zhang L
AD  - Bayer Consumer Care AG, Peter Merian-Strasse 84, 4002, Basel, Switzerland.
FAU - de Salvo, Raffaella
AU  - de Salvo R
AD  - Bayer Consumer Care AG, Peter Merian-Strasse 84, 4002, Basel, Switzerland.
FAU - Trapp, Sonja
AU  - Trapp S
AD  - Bayer Consumer Care AG, Peter Merian-Strasse 84, 4002, Basel, Switzerland.
FAU - Wigger-Alberti, Walter
AU  - Wigger-Alberti W
AD  - Bioskin GmbH, Messberg 4, 20095, Hamburg, Germany.
FAU - Williams, Ragna
AU  - Williams R
AD  - Bioskin GmbH, Messberg 4, 20095, Hamburg, Germany.
FAU - Delcour, Lucie
AU  - Delcour L
AD  - Oystershell Laboratories, Nijverheidsweg 10, 9820, Merelbeke, Belgium.
FAU - Rossel, Bart
AU  - Rossel B
AD  - Oystershell Laboratories, Nijverheidsweg 10, 9820, Merelbeke, Belgium.
FAU - Huisman, Maarten T
AU  - Huisman MT
AUID- ORCID: 0000-0001-7280-0398
AD  - Oystershell Laboratories, Nijverheidsweg 10, 9820, Merelbeke, Belgium. 
      mh@oystershell.be.
LA  - eng
PT  - Journal Article
DEP - 20200802
PL  - Switzerland
TA  - Dermatol Ther (Heidelb)
JT  - Dermatology and therapy
JID - 101590450
PMC - PMC7477032
OTO - NOTNLM
OT  - Abrasive wound model
OT  - BepanGel
OT  - Cooling
OT  - Cosmetic appearance
OT  - Efficacy
OT  - Flamozil
OT  - Hydrocolloid
OT  - Hydrogel
OT  - Tolerability
OT  - Zoralan
EDAT- 2020/08/04 06:00
MHDA- 2020/08/04 06:01
PMCR- 2020/08/02
CRDT- 2020/08/04 06:00
PHST- 2020/06/29 00:00 [received]
PHST- 2020/08/04 06:00 [pubmed]
PHST- 2020/08/04 06:01 [medline]
PHST- 2020/08/04 06:00 [entrez]
PHST- 2020/08/02 00:00 [pmc-release]
AID - 10.1007/s13555-020-00432-5 [pii]
AID - 432 [pii]
AID - 10.1007/s13555-020-00432-5 [doi]
PST - ppublish
SO  - Dermatol Ther (Heidelb). 2020 Oct;10(5):1075-1088. doi: 
      10.1007/s13555-020-00432-5. Epub 2020 Aug 2.