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.
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
|Contact: Patrick Medadofirstname.lastname@example.org|
|United States, Michigan|
|Wayne State University||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Aaron Brody, MD, MPH 313-577-1216 email@example.com|
|Principal Investigator:||Aaron Brody, MD, MPH||Wayne State University|