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Derma-Stent Novel Abscess Packing Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03171714
Recruitment Status : Unknown
Verified June 2017 by Aaron Brody, MD, MPH, Wayne State University.
Recruitment status was:  Recruiting
First Posted : May 31, 2017
Last Update Posted : June 8, 2017
Information provided by (Responsible Party):
Aaron Brody, MD, MPH, Wayne State University

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.

Condition or disease Intervention/treatment Phase
Cutaneous Abscess Device: Derma-Stent Device: Usual care, cotton gauze packing Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Derma-Stent Novel Abscess Packing Device (Pilot Study)
Actual Study Start Date : March 27, 2017
Estimated Primary Completion Date : November 30, 2017
Estimated Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess

Arm Intervention/treatment
Experimental: Derma-Stent
The novel silicon packing device made of a nonabsorbent material to pack a drained abscess for healing.
Device: Derma-Stent
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

Active Comparator: Usual Care, cotton gauze packing
Standard of care to pack a drained abscess for healing.
Device: Usual care, cotton gauze packing
Standard gauze packing used to pack a drained abscess.

Primary Outcome Measures :
  1. Likelihood of self removal [ Time Frame: 3-5 days ]
    Likelihood of self removal, as measured on a 1-10 Likert scale.

Secondary Outcome Measures :
  1. Clinical Failure Rate [ Time Frame: 32 days after baseline ]
    Defined by presence of: fever, increase in maximal diameter of erythema, worsening of wound swelling and tenderness.

  2. Recurrence Rate of Abscess [ Time Frame: 3-5 day and one month follow-up ]
    Recurrence rate of abscess at initial (3-5 day) and one month follow up.

  3. Cosmetic Result [ Time Frame: 3-5 day and one month ]
    Cosmetic result at both f/u visits, as measured subjectively by participants, utilizing a 1-10 Likert scale.

  4. Pain during procedure and packing removal [ Time Frame: baseline and 3-5 day ]
    Pain during procedure and packing removal, measured by a 1-10 visual acuity scale.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171714

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Contact: Patrick Medado 313-745-4621 pbmedado@med.wayne.edu

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United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Aaron Brody, MD, MPH    313-577-1216    abrody@med.wayne.edu   
Sponsors and Collaborators
Aaron Brody, MD, MPH
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Principal Investigator: Aaron Brody, MD, MPH Wayne State University

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Responsible Party: Aaron Brody, MD, MPH, Assistant Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT03171714    
Other Study ID Numbers: 091016M1F
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aaron Brody, MD, MPH, Wayne State University:
Drainage Catheter
Additional relevant MeSH terms:
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Pathologic Processes