Accelerated Wound Healing by a Topical Wound Healing Lipogel in Patients Undergoing Catheter De-placement - Evidence from a Randomized, Controlled Clinical Study

Thomas Eberlein; Sami Siam

doi:doi:10.11648/j.js.20200802.12

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Accelerated Wound Healing by a Topical Wound Healing Lipogel in Patients Undergoing Catheter De-placement - Evidence from a Randomized, Controlled Clinical Study

Thomas Eberlein, Sami Siam

Published in Journal of Surgery (Volume 8, Issue 2)

Received: 31 January 2020 Accepted: 21 February 2020 Published: 17 March 2020

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Abstract

Objective: The purpose of this clinical study was to assess a novel wound model and to compare the wound healing properties of a topical wound healing hydroactive lipogel (MediGel^®) promoting moist wound environment versus standard treatment by a standard plaster und dry environmental conditions in patients undergoing catheter de-placement as a model for non-acute wounds affecting all skin layers in real life conditions (moist environment does improve granulation & epithelialization supported by Lipogel – the MEDIGEL trial). Methods: Patients (n=69) admitted to the dialysis ward of a tertiary care institution with acute or chronic renal insufficiency and in need for dialysis were enrolled into a prospective, observer-blind, randomized, controlled, inter-individual experimental comparison study. Patients enrolled were undergoing placement of Sheldon multi-lumen catheter (11 French diameter) in the external jugular vein at the neck by Seldinger technique to enable access for hemodialysis. One group of patients which had catheter displaced after one session of hemodialysis was regarded as acute wound group. A different group of patients had catheter withdrawn after 14 (+/- 2 days) and was classified as non-acute wound group. Topical treatments were randomly allocated, i.e. traditional care with standard plaster (control group) or investigational product (promoting moist environment) beneath a standard plaster (investigational product). Wound healing was assessed (digital photography, visual scoring) and analyzed via comparison of area under curve at day 0, 3 and 7 after displacement of catheter. Results: Evaluation showed significantly faster wound healing results for the investigational product in comparison to standard (all time points) and with significant AUC difference in both patient groups, acute and non-acute. Visible re-epithelialization was recorded from day 3 to day 7 in acute wounds, delayed in non-acute wounds. Standard plaster-treated wounds remained open and had markedly larger wound area. Formation of fibrous scar tissue was minimal but less prominent in patients treated with the hydroactive lipogel in the non-acute group due to faster epithelialization promoted by moist environment. Conclusion: Clinically relevant accelerated epithelialization and faster wound healing were observed for the investigational product compared to traditional treatment indicating superiority of moist wound environmental conditions both in acute and non-acute wounds after displacement of catheter placed into the jugular vein for 5 hours or 2 weeks in patients undergoing hemodialysis. The model is an innovative approach to study acute and non-acute wounds affecting all three skin layers and should be further investigated.

Published in	Journal of Surgery (Volume 8, Issue 2)
DOI	10.11648/j.js.20200802.12
Page(s)	48-55
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2024. Published by Science Publishing Group

Keywords

Acute and Chronic Wound Healing, Novel Wound Model, Lipogel

References

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[2]	Australian Research Society (2019). Wound care evidence based guidelines summary. Retrieved from https://www.research.qut.au.html.
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[4]	Deutsche Gesellschaft für Wundheilung und Wundbehandlung e. V. (2012). AWMF Leitlinien-Register 091/001S3-Leitlinie Lokaltherapie chronischer Wunden bei den Risiken CVI, PAVK und Diabetes mellitus. Retrieved from http://www.awmf.org/leitlinien/detail/ll/091-001.html.
[5]	Heyer K, Augustin M, Protz K, Herberger K, Spehr C, Rustenach SJ (2013). Effectiveness of advanced versus conventional wound dressings on healing of chronic wounds: systematic review and meta-analysis. Dermatology. 226 (2): 172-84. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/23711429.
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[8]	Eberlein T, Gerke P, Lorenz H, Ammer R (2016). Advantages in wound healing by a topical easy to use wound healing lipo-gel for abrasive wounds-Evidence from a randomized, controlled experimental clinical study. Wound Medicine. Retrieved from https://doi.org/10.1016/j.wndm.2016.09.003.
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[12]	Wilhelm K-P, Wilhelm D, Bielfeldt S (2016) Models of wound healing: an emphasis on clinical studies. Skin Res Technol. doi: 10.1111/srt.12317. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/27503009.
[13]	Seldinger S (1953). Catheter replacement of the needle in percutaneous arteriography; a new technique. Acta radiol. 39 (5): 368-76. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/13057644.
[14]	Conz PA, Dissegna D, Rodighiero MP, La Greca G (1997). Cannulation of the internal jugular vein: comparison of the classic Seldinger technique and an ultrasound guided method. J Nephrol. 10 (6): 311-3. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/9442443.
[15]	Eming SA, Martin P, Tomic-Canic M (2014). Wound repair and regeneration: Mechanisms, signaling, and translation. Science translational medicine. 6 (265): 265. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4973620/.
[16]	EUnetHTA (2013). Retrieved from https://www.eunethta.eu/methodological-guideline-for-rea-of-pharmaceuticals-direct-and-indirect-comparison/.
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[22]	Wilhelm KP, Wilhelm D, Bielfeldt S (2017). Models of wound healing: an emphasis on clinical studies. Skin Research and Technology. 23 (1): 3-12. Retrieved from https://www.ncbi.nlm.nih.gov/pubmed/27503009.

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APA Style

Thomas Eberlein, Sami Siam. (2020). Accelerated Wound Healing by a Topical Wound Healing Lipogel in Patients Undergoing Catheter De-placement - Evidence from a Randomized, Controlled Clinical Study. Journal of Surgery, 8(2), 48-55. https://doi.org/10.11648/j.js.20200802.12

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ACS Style

Thomas Eberlein; Sami Siam. Accelerated Wound Healing by a Topical Wound Healing Lipogel in Patients Undergoing Catheter De-placement - Evidence from a Randomized, Controlled Clinical Study. J. Surg. 2020, 8(2), 48-55. doi: 10.11648/j.js.20200802.12

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AMA Style

Thomas Eberlein, Sami Siam. Accelerated Wound Healing by a Topical Wound Healing Lipogel in Patients Undergoing Catheter De-placement - Evidence from a Randomized, Controlled Clinical Study. J Surg. 2020;8(2):48-55. doi: 10.11648/j.js.20200802.12

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@article{10.11648/j.js.20200802.12,
  author = {Thomas Eberlein and Sami Siam},
  title = {Accelerated Wound Healing by a Topical Wound Healing Lipogel in Patients Undergoing Catheter De-placement - Evidence from a Randomized, Controlled Clinical Study},
  journal = {Journal of Surgery},
  volume = {8},
  number = {2},
  pages = {48-55},
  doi = {10.11648/j.js.20200802.12},
  url = {https://doi.org/10.11648/j.js.20200802.12},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.js.20200802.12},
  abstract = {Objective: The purpose of this clinical study was to assess a novel wound model and to compare the wound healing properties of a topical wound healing hydroactive lipogel (MediGel®) promoting moist wound environment versus standard treatment by a standard plaster und dry environmental conditions in patients undergoing catheter de-placement as a model for non-acute wounds affecting all skin layers in real life conditions (moist environment does improve granulation & epithelialization supported by Lipogel – the MEDIGEL trial). Methods: Patients (n=69) admitted to the dialysis ward of a tertiary care institution with acute or chronic renal insufficiency and in need for dialysis were enrolled into a prospective, observer-blind, randomized, controlled, inter-individual experimental comparison study. Patients enrolled were undergoing placement of Sheldon multi-lumen catheter (11 French diameter) in the external jugular vein at the neck by Seldinger technique to enable access for hemodialysis. One group of patients which had catheter displaced after one session of hemodialysis was regarded as acute wound group. A different group of patients had catheter withdrawn after 14 (+/- 2 days) and was classified as non-acute wound group. Topical treatments were randomly allocated, i.e. traditional care with standard plaster (control group) or investigational product (promoting moist environment) beneath a standard plaster (investigational product). Wound healing was assessed (digital photography, visual scoring) and analyzed via comparison of area under curve at day 0, 3 and 7 after displacement of catheter. Results: Evaluation showed significantly faster wound healing results for the investigational product in comparison to standard (all time points) and with significant AUC difference in both patient groups, acute and non-acute. Visible re-epithelialization was recorded from day 3 to day 7 in acute wounds, delayed in non-acute wounds. Standard plaster-treated wounds remained open and had markedly larger wound area. Formation of fibrous scar tissue was minimal but less prominent in patients treated with the hydroactive lipogel in the non-acute group due to faster epithelialization promoted by moist environment. Conclusion: Clinically relevant accelerated epithelialization and faster wound healing were observed for the investigational product compared to traditional treatment indicating superiority of moist wound environmental conditions both in acute and non-acute wounds after displacement of catheter placed into the jugular vein for 5 hours or 2 weeks in patients undergoing hemodialysis. The model is an innovative approach to study acute and non-acute wounds affecting all three skin layers and should be further investigated.},
 year = {2020}
}

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TY  - JOUR
T1  - Accelerated Wound Healing by a Topical Wound Healing Lipogel in Patients Undergoing Catheter De-placement - Evidence from a Randomized, Controlled Clinical Study
AU  - Thomas Eberlein
AU  - Sami Siam
Y1  - 2020/03/17
PY  - 2020
N1  - https://doi.org/10.11648/j.js.20200802.12
DO  - 10.11648/j.js.20200802.12
T2  - Journal of Surgery
JF  - Journal of Surgery
JO  - Journal of Surgery
SP  - 48
EP  - 55
PB  - Science Publishing Group
SN  - 2330-0930
UR  - https://doi.org/10.11648/j.js.20200802.12
AB  - Objective: The purpose of this clinical study was to assess a novel wound model and to compare the wound healing properties of a topical wound healing hydroactive lipogel (MediGel®) promoting moist wound environment versus standard treatment by a standard plaster und dry environmental conditions in patients undergoing catheter de-placement as a model for non-acute wounds affecting all skin layers in real life conditions (moist environment does improve granulation & epithelialization supported by Lipogel – the MEDIGEL trial). Methods: Patients (n=69) admitted to the dialysis ward of a tertiary care institution with acute or chronic renal insufficiency and in need for dialysis were enrolled into a prospective, observer-blind, randomized, controlled, inter-individual experimental comparison study. Patients enrolled were undergoing placement of Sheldon multi-lumen catheter (11 French diameter) in the external jugular vein at the neck by Seldinger technique to enable access for hemodialysis. One group of patients which had catheter displaced after one session of hemodialysis was regarded as acute wound group. A different group of patients had catheter withdrawn after 14 (+/- 2 days) and was classified as non-acute wound group. Topical treatments were randomly allocated, i.e. traditional care with standard plaster (control group) or investigational product (promoting moist environment) beneath a standard plaster (investigational product). Wound healing was assessed (digital photography, visual scoring) and analyzed via comparison of area under curve at day 0, 3 and 7 after displacement of catheter. Results: Evaluation showed significantly faster wound healing results for the investigational product in comparison to standard (all time points) and with significant AUC difference in both patient groups, acute and non-acute. Visible re-epithelialization was recorded from day 3 to day 7 in acute wounds, delayed in non-acute wounds. Standard plaster-treated wounds remained open and had markedly larger wound area. Formation of fibrous scar tissue was minimal but less prominent in patients treated with the hydroactive lipogel in the non-acute group due to faster epithelialization promoted by moist environment. Conclusion: Clinically relevant accelerated epithelialization and faster wound healing were observed for the investigational product compared to traditional treatment indicating superiority of moist wound environmental conditions both in acute and non-acute wounds after displacement of catheter placed into the jugular vein for 5 hours or 2 weeks in patients undergoing hemodialysis. The model is an innovative approach to study acute and non-acute wounds affecting all three skin layers and should be further investigated.
VL  - 8
IS  - 2
ER  -

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Author Information

Thomas Eberlein

Department of Surgery, College of Medicine and Medical Science, Arabian Gulf University, Manama, Bahrain
Sami Siam

Department of nephrology, University hospital Muenster, Westphalian Wilhelms University, Muenster, Germany

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APA Style

Thomas Eberlein, Sami Siam. (2020). Accelerated Wound Healing by a Topical Wound Healing Lipogel in Patients Undergoing Catheter De-placement - Evidence from a Randomized, Controlled Clinical Study. Journal of Surgery, 8(2), 48-55. https://doi.org/10.11648/j.js.20200802.12

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ACS Style

Thomas Eberlein; Sami Siam. Accelerated Wound Healing by a Topical Wound Healing Lipogel in Patients Undergoing Catheter De-placement - Evidence from a Randomized, Controlled Clinical Study. J. Surg. 2020, 8(2), 48-55. doi: 10.11648/j.js.20200802.12

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AMA Style

Thomas Eberlein, Sami Siam. Accelerated Wound Healing by a Topical Wound Healing Lipogel in Patients Undergoing Catheter De-placement - Evidence from a Randomized, Controlled Clinical Study. J Surg. 2020;8(2):48-55. doi: 10.11648/j.js.20200802.12

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@article{10.11648/j.js.20200802.12,
  author = {Thomas Eberlein and Sami Siam},
  title = {Accelerated Wound Healing by a Topical Wound Healing Lipogel in Patients Undergoing Catheter De-placement - Evidence from a Randomized, Controlled Clinical Study},
  journal = {Journal of Surgery},
  volume = {8},
  number = {2},
  pages = {48-55},
  doi = {10.11648/j.js.20200802.12},
  url = {https://doi.org/10.11648/j.js.20200802.12},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.js.20200802.12},
  abstract = {Objective: The purpose of this clinical study was to assess a novel wound model and to compare the wound healing properties of a topical wound healing hydroactive lipogel (MediGel®) promoting moist wound environment versus standard treatment by a standard plaster und dry environmental conditions in patients undergoing catheter de-placement as a model for non-acute wounds affecting all skin layers in real life conditions (moist environment does improve granulation & epithelialization supported by Lipogel – the MEDIGEL trial). Methods: Patients (n=69) admitted to the dialysis ward of a tertiary care institution with acute or chronic renal insufficiency and in need for dialysis were enrolled into a prospective, observer-blind, randomized, controlled, inter-individual experimental comparison study. Patients enrolled were undergoing placement of Sheldon multi-lumen catheter (11 French diameter) in the external jugular vein at the neck by Seldinger technique to enable access for hemodialysis. One group of patients which had catheter displaced after one session of hemodialysis was regarded as acute wound group. A different group of patients had catheter withdrawn after 14 (+/- 2 days) and was classified as non-acute wound group. Topical treatments were randomly allocated, i.e. traditional care with standard plaster (control group) or investigational product (promoting moist environment) beneath a standard plaster (investigational product). Wound healing was assessed (digital photography, visual scoring) and analyzed via comparison of area under curve at day 0, 3 and 7 after displacement of catheter. Results: Evaluation showed significantly faster wound healing results for the investigational product in comparison to standard (all time points) and with significant AUC difference in both patient groups, acute and non-acute. Visible re-epithelialization was recorded from day 3 to day 7 in acute wounds, delayed in non-acute wounds. Standard plaster-treated wounds remained open and had markedly larger wound area. Formation of fibrous scar tissue was minimal but less prominent in patients treated with the hydroactive lipogel in the non-acute group due to faster epithelialization promoted by moist environment. Conclusion: Clinically relevant accelerated epithelialization and faster wound healing were observed for the investigational product compared to traditional treatment indicating superiority of moist wound environmental conditions both in acute and non-acute wounds after displacement of catheter placed into the jugular vein for 5 hours or 2 weeks in patients undergoing hemodialysis. The model is an innovative approach to study acute and non-acute wounds affecting all three skin layers and should be further investigated.},
 year = {2020}
}

Copy | Download

TY  - JOUR
T1  - Accelerated Wound Healing by a Topical Wound Healing Lipogel in Patients Undergoing Catheter De-placement - Evidence from a Randomized, Controlled Clinical Study
AU  - Thomas Eberlein
AU  - Sami Siam
Y1  - 2020/03/17
PY  - 2020
N1  - https://doi.org/10.11648/j.js.20200802.12
DO  - 10.11648/j.js.20200802.12
T2  - Journal of Surgery
JF  - Journal of Surgery
JO  - Journal of Surgery
SP  - 48
EP  - 55
PB  - Science Publishing Group
SN  - 2330-0930
UR  - https://doi.org/10.11648/j.js.20200802.12
AB  - Objective: The purpose of this clinical study was to assess a novel wound model and to compare the wound healing properties of a topical wound healing hydroactive lipogel (MediGel®) promoting moist wound environment versus standard treatment by a standard plaster und dry environmental conditions in patients undergoing catheter de-placement as a model for non-acute wounds affecting all skin layers in real life conditions (moist environment does improve granulation & epithelialization supported by Lipogel – the MEDIGEL trial). Methods: Patients (n=69) admitted to the dialysis ward of a tertiary care institution with acute or chronic renal insufficiency and in need for dialysis were enrolled into a prospective, observer-blind, randomized, controlled, inter-individual experimental comparison study. Patients enrolled were undergoing placement of Sheldon multi-lumen catheter (11 French diameter) in the external jugular vein at the neck by Seldinger technique to enable access for hemodialysis. One group of patients which had catheter displaced after one session of hemodialysis was regarded as acute wound group. A different group of patients had catheter withdrawn after 14 (+/- 2 days) and was classified as non-acute wound group. Topical treatments were randomly allocated, i.e. traditional care with standard plaster (control group) or investigational product (promoting moist environment) beneath a standard plaster (investigational product). Wound healing was assessed (digital photography, visual scoring) and analyzed via comparison of area under curve at day 0, 3 and 7 after displacement of catheter. Results: Evaluation showed significantly faster wound healing results for the investigational product in comparison to standard (all time points) and with significant AUC difference in both patient groups, acute and non-acute. Visible re-epithelialization was recorded from day 3 to day 7 in acute wounds, delayed in non-acute wounds. Standard plaster-treated wounds remained open and had markedly larger wound area. Formation of fibrous scar tissue was minimal but less prominent in patients treated with the hydroactive lipogel in the non-acute group due to faster epithelialization promoted by moist environment. Conclusion: Clinically relevant accelerated epithelialization and faster wound healing were observed for the investigational product compared to traditional treatment indicating superiority of moist wound environmental conditions both in acute and non-acute wounds after displacement of catheter placed into the jugular vein for 5 hours or 2 weeks in patients undergoing hemodialysis. The model is an innovative approach to study acute and non-acute wounds affecting all three skin layers and should be further investigated.
VL  - 8
IS  - 2
ER  -

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