Recruiting
Phase 1
Phase 2

Derma-Stent

Sponsor:

Aaron Brody, MD, MPH

Code:

NCT03171714

Conditions

Cutaneous Abscess

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Derma-Stent

Usual care, cotton gauze packing

Study Details

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

Study ID

NCT03171714

Start date

Mar 27, 2017

Status verified date

Jun, 2017

Completion date

Dec 15, 2017

Anticipated

Primary completion date

Nov 30, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Derma-Stent

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

active comparator: Usual Care, cotton gauze packing

Standard of care to pack a drained abscess for healing.

Interventions

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

Usual care, cotton gauze packing

Standard gauze packing used to pack a drained abscess.

Primary outcome measure

  • Likelihood of self removal [ Time Frame: 3-5 days ]

Central Contacts and Locations

Central contacts

Patrick Medado

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

Locations

Wayne State University

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Aaron Brody, MD, MPH

313-577-1216abrody@med.wayne.edu

More Information

Sponsor

Aaron Brody, MD, MPH

Last update posted

Jun 8, 2017

Last verified

Jun, 2017

Keywords

  • Drainage Catheter

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Aaron Brody, MD, MPH on 2017-06-08.