Derma-Stent Clinical Trial is Complete!

A randomized controlled clinical trial on Mar-Med’s new Derma-Stent device has been completed at Wayne State University under Principal Investigator Aaron Brody, MD, MPH.  The trial involved 60 participants comparing standard packing gauze vs Derma-Stent in various outcomes for abscess treatment.  This study was funded through a development matching grant from Mar-Med and the State of Michigan Corporate Relations Network, Small Company Innovation Program.  The final manuscript on the trial is pending and expected to be published soon. 

Preceding the final trial manuscript, an article describing the first documented use of the Derma-Stent in a human patient has been published in The Journal of Emergency Medicine, Vol. 56, No. 3, pp. 298–300, 2019.  For more info on the trial, please visit the trial link at the US National Library of Medicine website.

The following are excerpts from the article, with share link provided directly below.

https://authors.elsevier.com/c/1YmOK2dT1CgD8l

A Novel Silicon Device for the Packing of Cutaneous Abscesses
by Aaron M. Brody, MD, MPH,* John Gallien, MD,* Danielle Murphy, BS,* and Jerry Marogil, JD

ABSTRACT

“Superficial skin abscesses are commonly encountered in emergency medicine practice. Standard treatment includes incision, drainage, and often packing with a gauze strip. The packing component of the procedure has several negative potential outcomes, is painful, and necessitates a return visit for removal. Discussion: Here we report the first case in which a novel silicon packing device was utilized. The patient presented with a facial abscess, which was incised and drained. The novel device was inserted, and removed by the patient independently, without complication. Both patient and provider reported satisfaction with the novel procedure, and noted low pain scores. Conclusions: This device has the potential to replace traditional packing, and will require further study through a controlled trial to assess for safety and efficacy.”

INTRODUCTION

“The number of soft tissue and skin infections drastically increased from 1.2 million to 3.5 million between the years 1993 and 2005…  The standard of care for treating abscesses is incision and drainage…”

“Packing can be painful and uncomfortable for patients, and necessitates a second visit to a health care provider for removal. Additionally, cases of toxic shock developing from packing strips that were not removed in a timely manner have been reported…”

“Addressing one of the above-mentioned limitations, a novel silicon abscess packing device was developed, the Derma-Stent (Mar-Med, Grand Rapids, MI)…  We hereby describe the first documented use of the Derma-Stent in a human patient…”

CASE PRESENTATION

“The patient was a 27-year-oldman, presenting with a chief complaint of an abscess on his left lower jaw… Informed consent was obtained and the patient was enrolled as the first patient in the single-arm, pilot study of the Derma-Stent device… A Derma-Stent packing device was inserted through one incision, and drawn out the opposite end… On postoperative day 3… the patient was successfully able to remove the packing device on his own.”

CONCLUSION 

“In this single case, the provider found the device easy to use… was well tolerated by the patient and the patient was able to remove the device independently… Further study of this device is underway in the form of a single-arm pilot study; pending results, a randomized control trial is planned to further assess feasibility.”

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Acknowledgments – This study was funded through a development matching grant from Mar-Med Company and the State of Michigan Corporate Relations Network, Small Company Innovation Program. The first author had final discretion over the content.

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References

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  2. Qualls ML, Mooney MM, Camargo CA, Zucconi T, Hooper DC, Pallin DJ. Emergency department visit rates for abscess versus other skin infections during the emergence of community-associated methicillin-resistant Staphylococcus aureus, 1997–2007. Clin Infect Dis 2012;55:103–5.
  3. Leinwand M, Downing M, Slater D, Beck M, Burton K, Moyer D. Incision and drainage of subcutaneous abscesses without the use of packing. J Pediatr Surg 2013;48:1962–5.
  4. Kessler DO, Krantz A, Mojica M. Randomized trial comparing wound packing to no wound packing following incision and drainage of superficial skin abscesses in the pediatric emergency department. Pediatr Emerg Care 2012;28:514–7.
  5. Talan DA, Mower WR, Krishnadasan A, et al. Trimethoprim-sulfamethoxazole versus placebo for uncomplicated skin abscess.N Engl J Med 2016;374:823–32.
  6. Reingold AL, Dan BB, Shands KN, Broome CV. Toxic-shock syndrome not associated with menstruation. A review of 54 cases. Lancet 1982;1:1–4.
  7. Reingold AL, Hargrett NT, Dan BB, Shands KN, Strickland BY, Broome CV. Nonmenstrual toxic shock syndrome: a review of 130 cases. Ann Intern Med 1982;96:871–4.
  8. Tsoraides SS, Pearl RH, Stanfill AB,Wallace LJ, Vegunta RK. Incision and loop drainage: a minimally invasive technique for subcutaneous abscess management in children. J Pediatr Surg 2010;45: 606–9.
  9. Ladd AP, Levy MS, Quilty J. Minimally invasive technique in treatment of complex, subcutaneous abscesses in children. J Pediatr Surg 2010;45:1562–6.
  10. Gaszynski R, Punch G, Verschuer K. Loop and drain technique for subcutaneous abscess: a safe minimally invasive procedure in an adult population. ANZ J Surg 2018;88:87–90.
  11. Gottlieb M, Peksa GD. Comparison of the loop technique with incision and drainage for soft tissue abscesses: a systematic review and meta-analysis. Am J Emerg Med 2018;36:128–33.
 
 
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