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Pilot-Study Lumina Switchable Post-Op Dressing & Postsurgical Wounds: A Non-interventional, Non-placebo-controlled, National Pilot Study

Received: 1 June 2020    Accepted: 12 August 2020    Published: 3 September 2020
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Abstract

Dressings applied to primarily closed surgical incisions should be appropriate interactive dressing [13] and demonstrate an ability to protect the wound from contaminants and trauma, manage exudate, and avoid excessive pressure to the incision line. Additionally, they should be flexible, well fixed to the skin on application, skin protective (e.g. reduce the risk of blistering or irritation, not excessively adhesive) and waterproof [14]. Film dressings were one of the first modern wound-dressing products. They are extremely flexible, transparent and adhesive. During the removal of the dressing skin stress occurs. An essential role are shearing and friction forces between skin and wound dressing playing. This problem includes missing elasticity, flexibility and too strong adhesion. A non-interventional, non-placebo-controlled, national pilot study was done to prove a new shearing force reducing technique and dressing. The used post-op dressing consists of a thin film backing with a switchable polyurethane adhesive and non-adhering absorption pad. Before removal the adhesion is reduced by illuminating the dressing with the UV-A lamp. 52 patients at a mean age of 55.79 years (SD±16.22) with a total of 52 wounds were included in the study, all of them finalized the 1-week study period. At baseline, pain was measured with a mean of 3.52 (SD±1.26), during the study period pain decreased to a mean of 2.10 (SD±0.97) (VAS 0=no pain, 10=excruciating pain). Significance was calculated as 0,000 (paired t-test). At each dressing change, pain level after dressing change was rated lower compared to the pain level before dressing change. Overall, pain level decreased over the study period. The removal of the dressing after illumination with the UV-A lamp was rated in mean with 1.79 (2. Visit) and 1.86 (3. Visit) on the 6–point-scale (1=very good – 6=insufficient). Significance was calculated as 0,000 for visit 3 (one sample t-test [test value=3,0]). Reactions on the wound edge/wound surroundings have not been reported. In contrast, a reduction of maceration and redness of the wound edge/wound surrounding was observed. The results confirm that the adhesive ensures a safe and effective occlusion/fixation of the dressing and that the strong adhesion enables dressing to function according to specification. There was no deterioration of the wound situation or an infection in any of the cases. The switchable function of the adhesive allows the adhesion of the post-op dressing to the skin to be reduced when illuminated by the supplied UV-A lamp. The results of the present study show that the reduced adhesion upon illumination enables easy and comfortable removal of the dressing.

Published in Journal of Surgery (Volume 8, Issue 5)
DOI 10.11648/j.js.20200805.12
Page(s) 153-157
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

Postsurgical Wound Dressing, Primarily Closed Wounds, Shearing Forces, Illumination with UV-Lamp, Reduction Stress During Dressing Change

References
[1] Kaihan Yao. Post-operative wound management. AUSTRALIAN FAMILY PHYSICIAN VOL. 42, NO. 12, DECEMBER 2013.
[2] Velnar T, Bailey T, Smrkolj V. The wound healing process: an overview of the cellular and molecular mechanisms. J Int Med Res 2009; 37: 1528–42.
[3] Bryant RA, Nix DP. Acute & Chronic Wounds: Current Management Concepts. 5th ed. St. Louis, MO: Elsevier; 2016.
[4] Arroyo AA, Casanova PL, Soriano JV, Torra I Bou JE. Open-label clinical trial comparing the clinical and economic effectiveness of using a polyurethane film surgical dressing with gauze surgical dressings in the care of post-operative surgical wounds. Int Wound J. 2015; 12 (3): 285-292. doi: 10.1111/iwj.12099.
[5] Meuleneire F. A vapour-permeable film dressing used on superficial wounds. Br J Nurs. 2014 Aug 12; 23 (15): S36, S38-43. doi: 10.12968/bjon.2014.23. Sup15.s36.
[6] Ousey K, Wasek S Clinician perspectives on medical adhesive-related skin injuries. Wounds UK Vol 12 No 4 2016.
[7] Davies P, Rippon M: Evidence review: the clinical benefits of safetac technology in wound care. J Wound Care 2008; Suppl: 3–31 MEDLINE.
[8] EWMA Position Document: Pain at wound dressing changes. © MEDICAL EDUCATION PARTNERSHIP LTD.
[9] McNichol L, Lund C, Rosen T, Gray M (2013). Medical Adhesives and Patient Safety: State of the Science: Consensus statements for the assessment, prevention, and treatment of adhesive-related skin injuries. J Wound Ostomy Continence Nurs 40 (4): 365-80.
[10] Cutting KF (2008). Impact of adhesive surgical tape and wound dressings on the skin, with reference to skin stripping. J Wound Care 17 (4): 157-8, 160-2.
[11] Denyer J (2011). Reducing pain during the removal of adhesive and adherent products. Br J Nurs 20 (suppl 15): S28-S35.
[12] Maene B (2013). Hidden costs of medical tape induced skin injuries. Wounds UK 9 (1): 46-50.
[13] National Institute for Health and Clinical Excellence (NICE). Surgical site infection: evidence update April 2019. www.nice.org.uk/guidance/ng125/resources/surgical-site-infections-prevention-and-treatment-pdf-66141660564421. Accessed August 11, 2020.
[14] Incision care and dressing selection in surgical wounds: Findings from an international meeting of surgeons. Wounds International 2019 July 2019 www.woundsinternational.com/resources/details/incision-care-and-dressing-selection-surgical-wounds-findings-international-meeting-surgeons. Accessed August 11, 2020.
[15] Ewart J: How to identify and treat allergies to wound therapies. Wound Essentials 2015, Vol 10 No 2.
Cite This Article
  • APA Style

    Michael Helmut Schmitz, Sven Rogmans, Sabine Kasparek, Nesat Mustafi. (2020). Pilot-Study Lumina Switchable Post-Op Dressing & Postsurgical Wounds: A Non-interventional, Non-placebo-controlled, National Pilot Study. Journal of Surgery, 8(5), 153-157. https://doi.org/10.11648/j.js.20200805.12

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    ACS Style

    Michael Helmut Schmitz; Sven Rogmans; Sabine Kasparek; Nesat Mustafi. Pilot-Study Lumina Switchable Post-Op Dressing & Postsurgical Wounds: A Non-interventional, Non-placebo-controlled, National Pilot Study. J. Surg. 2020, 8(5), 153-157. doi: 10.11648/j.js.20200805.12

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    AMA Style

    Michael Helmut Schmitz, Sven Rogmans, Sabine Kasparek, Nesat Mustafi. Pilot-Study Lumina Switchable Post-Op Dressing & Postsurgical Wounds: A Non-interventional, Non-placebo-controlled, National Pilot Study. J Surg. 2020;8(5):153-157. doi: 10.11648/j.js.20200805.12

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  • @article{10.11648/j.js.20200805.12,
      author = {Michael Helmut Schmitz and Sven Rogmans and Sabine Kasparek and Nesat Mustafi},
      title = {Pilot-Study Lumina Switchable Post-Op Dressing & Postsurgical Wounds: A Non-interventional, Non-placebo-controlled, National Pilot Study},
      journal = {Journal of Surgery},
      volume = {8},
      number = {5},
      pages = {153-157},
      doi = {10.11648/j.js.20200805.12},
      url = {https://doi.org/10.11648/j.js.20200805.12},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.js.20200805.12},
      abstract = {Dressings applied to primarily closed surgical incisions should be appropriate interactive dressing [13] and demonstrate an ability to protect the wound from contaminants and trauma, manage exudate, and avoid excessive pressure to the incision line. Additionally, they should be flexible, well fixed to the skin on application, skin protective (e.g. reduce the risk of blistering or irritation, not excessively adhesive) and waterproof [14]. Film dressings were one of the first modern wound-dressing products. They are extremely flexible, transparent and adhesive. During the removal of the dressing skin stress occurs. An essential role are shearing and friction forces between skin and wound dressing playing. This problem includes missing elasticity, flexibility and too strong adhesion. A non-interventional, non-placebo-controlled, national pilot study was done to prove a new shearing force reducing technique and dressing. The used post-op dressing consists of a thin film backing with a switchable polyurethane adhesive and non-adhering absorption pad. Before removal the adhesion is reduced by illuminating the dressing with the UV-A lamp. 52 patients at a mean age of 55.79 years (SD±16.22) with a total of 52 wounds were included in the study, all of them finalized the 1-week study period. At baseline, pain was measured with a mean of 3.52 (SD±1.26), during the study period pain decreased to a mean of 2.10 (SD±0.97) (VAS 0=no pain, 10=excruciating pain). Significance was calculated as 0,000 (paired t-test). At each dressing change, pain level after dressing change was rated lower compared to the pain level before dressing change. Overall, pain level decreased over the study period. The removal of the dressing after illumination with the UV-A lamp was rated in mean with 1.79 (2. Visit) and 1.86 (3. Visit) on the 6–point-scale (1=very good – 6=insufficient). Significance was calculated as 0,000 for visit 3 (one sample t-test [test value=3,0]). Reactions on the wound edge/wound surroundings have not been reported. In contrast, a reduction of maceration and redness of the wound edge/wound surrounding was observed. The results confirm that the adhesive ensures a safe and effective occlusion/fixation of the dressing and that the strong adhesion enables dressing to function according to specification. There was no deterioration of the wound situation or an infection in any of the cases. The switchable function of the adhesive allows the adhesion of the post-op dressing to the skin to be reduced when illuminated by the supplied UV-A lamp. The results of the present study show that the reduced adhesion upon illumination enables easy and comfortable removal of the dressing.},
     year = {2020}
    }
    

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  • TY  - JOUR
    T1  - Pilot-Study Lumina Switchable Post-Op Dressing & Postsurgical Wounds: A Non-interventional, Non-placebo-controlled, National Pilot Study
    AU  - Michael Helmut Schmitz
    AU  - Sven Rogmans
    AU  - Sabine Kasparek
    AU  - Nesat Mustafi
    Y1  - 2020/09/03
    PY  - 2020
    N1  - https://doi.org/10.11648/j.js.20200805.12
    DO  - 10.11648/j.js.20200805.12
    T2  - Journal of Surgery
    JF  - Journal of Surgery
    JO  - Journal of Surgery
    SP  - 153
    EP  - 157
    PB  - Science Publishing Group
    SN  - 2330-0930
    UR  - https://doi.org/10.11648/j.js.20200805.12
    AB  - Dressings applied to primarily closed surgical incisions should be appropriate interactive dressing [13] and demonstrate an ability to protect the wound from contaminants and trauma, manage exudate, and avoid excessive pressure to the incision line. Additionally, they should be flexible, well fixed to the skin on application, skin protective (e.g. reduce the risk of blistering or irritation, not excessively adhesive) and waterproof [14]. Film dressings were one of the first modern wound-dressing products. They are extremely flexible, transparent and adhesive. During the removal of the dressing skin stress occurs. An essential role are shearing and friction forces between skin and wound dressing playing. This problem includes missing elasticity, flexibility and too strong adhesion. A non-interventional, non-placebo-controlled, national pilot study was done to prove a new shearing force reducing technique and dressing. The used post-op dressing consists of a thin film backing with a switchable polyurethane adhesive and non-adhering absorption pad. Before removal the adhesion is reduced by illuminating the dressing with the UV-A lamp. 52 patients at a mean age of 55.79 years (SD±16.22) with a total of 52 wounds were included in the study, all of them finalized the 1-week study period. At baseline, pain was measured with a mean of 3.52 (SD±1.26), during the study period pain decreased to a mean of 2.10 (SD±0.97) (VAS 0=no pain, 10=excruciating pain). Significance was calculated as 0,000 (paired t-test). At each dressing change, pain level after dressing change was rated lower compared to the pain level before dressing change. Overall, pain level decreased over the study period. The removal of the dressing after illumination with the UV-A lamp was rated in mean with 1.79 (2. Visit) and 1.86 (3. Visit) on the 6–point-scale (1=very good – 6=insufficient). Significance was calculated as 0,000 for visit 3 (one sample t-test [test value=3,0]). Reactions on the wound edge/wound surroundings have not been reported. In contrast, a reduction of maceration and redness of the wound edge/wound surrounding was observed. The results confirm that the adhesive ensures a safe and effective occlusion/fixation of the dressing and that the strong adhesion enables dressing to function according to specification. There was no deterioration of the wound situation or an infection in any of the cases. The switchable function of the adhesive allows the adhesion of the post-op dressing to the skin to be reduced when illuminated by the supplied UV-A lamp. The results of the present study show that the reduced adhesion upon illumination enables easy and comfortable removal of the dressing.
    VL  - 8
    IS  - 5
    ER  - 

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Author Information
  • Research and Studies, MCS Medical Consulting, Oberahr, Germany

  • Clinic for Orthopaedics, Trauma and Spinal Surgery, Krankenhaus Nordwest, Frankfurt am Main, Germany

  • Clinic for Orthopaedics, Trauma and Spinal Surgery, Krankenhaus Nordwest, Frankfurt am Main, Germany

  • Vascular Surgery and Vascular Medicine, Krankenhaus Nordwest, Frankfurt am Main, Germany

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