Derma-Stent Novel Abscess Packing Device

NCT03171714 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-06-08

No results posted yet for this study

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

Interventions

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

DEVICE

Usual care, cotton gauze packing

Standard gauze packing used to pack a drained abscess.

Sponsors & Collaborators

  • Mar-Med

    collaborator UNKNOWN
  • Aaron Brody, MD, MPH

    lead OTHER

Principal Investigators

  • Aaron Brody, MD, MPH · Wayne State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-27
Primary Completion
2017-11-30
Completion
2017-12-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03171714 on ClinicalTrials.gov