Derma-Stent Novel Abscess Packing Device
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|ClinicalTrials.gov Identifier: NCT03171714|
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : June 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous Abscess||Device: Derma-Stent Device: Usual care, cotton gauze packing||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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:
|Masking:||None (Open Label)|
|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|
The novel silicon packing device made of a nonabsorbent material to pack a drained abscess for healing.
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.
- Likelihood of self removal [ Time Frame: 3-5 days ]Likelihood of self removal, as measured on a 1-10 Likert scale.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171714
|Contact: Patrick Medadoemail@example.com|
|United States, Michigan|
|Wayne State University||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Aaron Brody, MD, MPH 313-577-1216 firstname.lastname@example.org|
|Principal Investigator:||Aaron Brody, MD, MPH||Wayne State University|