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Derma-Stent Novel Abscess Packing Device

This study is currently recruiting participants.
Verified June 2017 by Aaron Brody, MD, MPH, Wayne State University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03171714
First Posted: May 31, 2017
Last Update Posted: June 8, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Mar-Med
Information provided by (Responsible Party):
Aaron Brody, MD, MPH, Wayne State University
  Purpose
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 Intervention Phase
Cutaneous Abscess Device: Derma-Stent Device: Usual care, cotton gauze packing Phase 1 Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Aaron Brody, MD, MPH, Wayne State University:

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


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 60
Actual Study Start Date: March 27, 2017
Estimated Study Completion Date: December 15, 2017
Estimated Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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


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

Locations
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
Mar-Med
Investigators
Principal Investigator: Aaron Brody, MD, MPH Wayne State University
  More Information

Publications:

Responsible Party: Aaron Brody, MD, MPH, Assistant Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT03171714     History of Changes
Other Study ID Numbers: 091016M1F
First Submitted: May 26, 2017
First Posted: May 31, 2017
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Abscess
Suppuration
Infection
Inflammation
Pathologic Processes