Derma-Stent Novel Abscess Packing Device

NCT03171714 | Unknown Phase 1

• 1 other identifier: 091016M1F
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this research study, a device called the Derma-Stent will be tested. The sponsor of the study, Mar-Med Company, will supply the device. This device is used to drain a cutaneous abscess, which is a skin infection that results in buildup of pus under the skin. Currently, the normal treatment for this abscess is to cut and drain and the wound, and later pack the wound with gauze. Packing is done to prevent the pus to accumulate again. But regular gauze is difficult for patient to remove themselves, so another visit to the doctor is usually necessary. The Derma-Stent device will be tested to see how easily patients can remove this by themselves and if it is less painful and more effective than normal gauze packing.

Conditions

Cutaneous Abscess

Keywords

Drainage Catheter

Outcome Measures

Primary Outcomes (1)

• Likelihood of self removal

  Likelihood of self removal, as measured on a 1-10 Likert scale.

  3-5 days

Secondary Outcomes (4)

• Clinical Failure Rate

  32 days after baseline

• Recurrence Rate of Abscess

  3-5 day and one month follow-up

• Cosmetic Result

  3-5 day and one month

• Pain during procedure and packing removal

  baseline and 3-5 day

Study Arms (2)

Derma-Stent

EXPERIMENTAL

The novel silicon packing device made of a nonabsorbent material to pack a drained abscess for healing.

Device: Derma-Stent

Usual Care, cotton gauze packing

ACTIVE COMPARATOR

Standard of care to pack a drained abscess for healing.

Device: Usual care, cotton gauze packing

Interventions

Derma-Stent DEVICE

The novel device will facilitate self removal by patients, as it has a narrower profile, and, as a nonabsorbent material, will not become saturated with bodily fluids. Although it will not absorb body fluids

Derma-Stent

Usual care, cotton gauze packing DEVICE

Standard gauze packing used to pack a drained abscess.

Usual Care, cotton gauze packing

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ED patient \> 18, \< 90.
• Abscess total dimensions (z+y+z) by ultrasound greater or equal to 5 cm.
• Consent to participate in research protocol.
• Assessment by attending physician that the abscess will require packing.

You may not qualify if:

• Patients requiring admission for skin and soft tissue infection.
• Abscess drainage requiring procedural sedation.
• Abscesses requiring incision and drainage in the operating room.
• Inability to comprehend consent and follow up instructions.
• Prisoners.
• Pregnant women.

Sponsors & Collaborators

• Aaron Brody, MD, MPH: lead
• Mar-Med: collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

RECRUITING

Related Publications (6)

• Pallin DJ, Egan DJ, Pelletier AJ, Espinola JA, Hooper DC, Camargo CA Jr. Increased US emergency department visits for skin and soft tissue infections, and changes in antibiotic choices, during the emergence of community-associated methicillin-resistant Staphylococcus aureus. Ann Emerg Med. 2008 Mar;51(3):291-8. doi: 10.1016/j.annemergmed.2007.12.004. Epub 2008 Jan 28.

  PMID: 18222564 BACKGROUND

• Qualls ML, Mooney MM, Camargo CA Jr, 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 Jul;55(1):103-5. doi: 10.1093/cid/cis342. Epub 2012 Mar 28.

  PMID: 22460965 BACKGROUND

• Singer AJ, Talan DA. Management of skin abscesses in the era of methicillin-resistant Staphylococcus aureus. N Engl J Med. 2014 Mar 13;370(11):1039-47. doi: 10.1056/NEJMra1212788. No abstract available.

  PMID: 24620867 BACKGROUND

• 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 Mar;45(3):606-9. doi: 10.1016/j.jpedsurg.2009.06.013.

  PMID: 20223328 BACKGROUND

• Ladd AP, Levy MS, Quilty J. Minimally invasive technique in treatment of complex, subcutaneous abscesses in children. J Pediatr Surg. 2010 Jul;45(7):1562-6. doi: 10.1016/j.jpedsurg.2010.03.025.

  PMID: 20638546 BACKGROUND

• 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 Jan;88(1-2):87-90. doi: 10.1111/ans.13709. Epub 2016 Sep 12.

  PMID: 27621209 BACKGROUND

Study Officials

• Aaron Brody, MD, MPH

  Wayne State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Medado

CONTACT

313-745-4621; pbmedado@med.wayne.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Phase 1 - Pilot Trial: As this device has never been used on humans, the investigators will first deploy a pilot, uncontrolled trial of 10 subjects to assess for safety, and further refine outcome measures. The same protocol will be followed as the controlled trial, except the randomization. Phase 2 - Controlled Trial: 25 patients in each arm: 1. Novel silicon packing device 2. Usual Care, cotton gauze packing

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 31, 2017
• Study Start: March 27, 2017
• Primary Completion: November 30, 2017
• Study Completion: December 15, 2017
• Last Updated: June 8, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)