Derma-Stent Novel Abscess Packing Device
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Cutaneous Abscess
In brief
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.
Key facts
- Study ID
- NCT03171714
- Run by
- Aaron Brody, MD, MPH
- People needed
- 60
- Starts
- 2017-03-27
- Expected to finish
- 2017-12-15
- Last updated by the study team
- 2017-06-08
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Wayne State University — Detroit, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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