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Derma-Stent Novel Abscess Packing Device

Primary Purpose

Cutaneous Abscess

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Derma-Stent
Usual care, cotton gauze packing
Sponsored by
Aaron Brody, MD, MPH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Abscess focused on measuring Drainage Catheter

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wayne State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Derma-Stent

Usual Care, cotton gauze packing

Arm Description

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

Standard of care to pack a drained abscess for healing.

Outcomes

Primary Outcome Measures

Likelihood of self removal
Likelihood of self removal, as measured on a 1-10 Likert scale.

Secondary Outcome Measures

Clinical Failure Rate
Defined by presence of: fever, increase in maximal diameter of erythema, worsening of wound swelling and tenderness.
Recurrence Rate of Abscess
Recurrence rate of abscess at initial (3-5 day) and one month follow up.
Cosmetic Result
Cosmetic result at both f/u visits, as measured subjectively by participants, utilizing a 1-10 Likert scale.
Pain during procedure and packing removal
Pain during procedure and packing removal, measured by a 1-10 visual acuity scale.

Full Information

First Posted
May 26, 2017
Last Updated
June 6, 2017
Sponsor
Aaron Brody, MD, MPH
Collaborators
Mar-Med
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1. Study Identification

Unique Protocol Identification Number
NCT03171714
Brief Title
Derma-Stent Novel Abscess Packing Device
Official Title
Derma-Stent Novel Abscess Packing Device (Pilot Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Anticipated)
Study Completion Date
December 15, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aaron Brody, MD, MPH
Collaborators
Mar-Med

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background: Cutaneous abscess is an infectious condition that affects millions of people each year, and the incidence is on the rise. Between 1993 and 2005, the annual number of emergency department (ED) visits for skin and soft tissue infections increased from 1.2 to 3.4 million, and this largely attributed to a rise in the prevalence of Methicillin Resistant Staphylococcus Aureus (MRSA) in the community. The standard treatment for cutaneous abscess is incision and drainage at bedside in the ED. Following this procedure, many clinicians insert a strip of gauze, known as packing, to maintain the open surgical incision, enhance drainage, and prevent re-accumulation of the abscess. If the abscess is packed, patients typically have to return in 2-3 days for a repeat visit to have the packing removed. The present standard of care, gauze packing, is difficult for patients to remove alone, as the packing itself becomes impregnated with pus and blood. Additionally, the packing procedure can be painful, despite the use of local anesthetics. A newer approach advocates for the use of a silicon string, known as a PDS loop for purposes of packing and drainage. While this approach can reduce pain, and is equally effective in terms of healing time, and treatment failure, the PDS, or Vessiloop is not readily available in emergency departments and outpatient clinics, as it is a specialized sterile surgical device used in vascular procedures. Furthermore, this procedure does not facilitate irrigation of the abscess cavity, since a much smaller incision is made. Finally, the PDS loop requires a surgical knot which may come loose. Objective: To investigate the use of a novel silicon packing device, the 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, it is believed that the Derma-stent will achieve the objective of wound healing by maintaining the opening of the surgical incision. Hypothesis: The acceptability of self removal will be significantly higher for the novel device. Study Protocol: ED Visit Abscess measured by ultrasound. Study will be performed by a trained research assistant, and will be verified by a physician certified to interpret soft tissue sonographic images. Abscess photographed, with measurement tape, to allow for objective measurement of skin induration and erythema. Abscess will be incised and drained, utilizing standard of care technique, with local anesthetic Packing performed according to randomization group. Sterile dressing applied. Subject completes assessment form - pain scale. Practitioner fills out assessment form - ease of use. Follow up visit 1 - 3-5 days Removal of packing. Subjects will be asked to remove packing on their own under supervision of the physician. Physician will remove the packing if they not able to. Measurement of abscess diameter and volume, utilizing measuring tape, photograph, and point of care ultrasound. Practitioner and subject assessment form as above, but adding ease of procedure, and likelihood that subject would have removed packing at home. Follow up visit 2 - 24-32 days Assessment of residual erythema and fluid collection by measurement, photograph, and US Practitioner and subject assessment including global satisfaction, and satisfaction with cosmetic result. Adverse Effects: If physician is impressed that the wound is not appropriately at either f/u visit, antibiotics may be prescribed, and repacking may be performed, utilizing gauze packing strip. Use of antibiotics for abscess is controversial and most physicians prescribe these on a case by case basis. Antibiotics will be prescribed at the discretion of the physician and not related to the study protocol. Population: Convenience sample of adult patients presenting with uncomplicated cutaneous abscess amenable to bedside drainage to either DRH or SGH ED. Sample size calculation: As this is a hypothesis generating study, and the effect size is unknown, formal sample size calculation was not performed. 60 patients was chosen as the sample size.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Abscess
Keywords
Drainage Catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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: Novel silicon packing device Usual Care, cotton gauze packing
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Derma-Stent
Arm Type
Experimental
Arm Description
The novel silicon packing device made of a nonabsorbent material to pack a drained abscess for healing.
Arm Title
Usual Care, cotton gauze packing
Arm Type
Active Comparator
Arm Description
Standard of care to pack a drained abscess for healing.
Intervention Type
Device
Intervention Name(s)
Derma-Stent
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Usual care, cotton gauze packing
Intervention Description
Standard gauze packing used to pack a drained abscess.
Primary Outcome Measure Information:
Title
Likelihood of self removal
Description
Likelihood of self removal, as measured on a 1-10 Likert scale.
Time Frame
3-5 days
Secondary Outcome Measure Information:
Title
Clinical Failure Rate
Description
Defined by presence of: fever, increase in maximal diameter of erythema, worsening of wound swelling and tenderness.
Time Frame
32 days after baseline
Title
Recurrence Rate of Abscess
Description
Recurrence rate of abscess at initial (3-5 day) and one month follow up.
Time Frame
3-5 day and one month follow-up
Title
Cosmetic Result
Description
Cosmetic result at both f/u visits, as measured subjectively by participants, utilizing a 1-10 Likert scale.
Time Frame
3-5 day and one month
Title
Pain during procedure and packing removal
Description
Pain during procedure and packing removal, measured by a 1-10 visual acuity scale.
Time Frame
baseline and 3-5 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Medado
Phone
313-745-4621
Email
pbmedado@med.wayne.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron Brody, MD, MPH
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Brody, MD, MPH
Phone
313-577-1216
Email
abrody@med.wayne.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18222564
Citation
Pallin DJ, Egan DJ, Pelletier AJ, Espinola JA, Hooper DC, Camargo CA Jr. Increased US emergency department visits for skin and soft tissue infections, and changes in antibiotic choices, during the emergence of community-associated methicillin-resistant Staphylococcus aureus. Ann Emerg Med. 2008 Mar;51(3):291-8. doi: 10.1016/j.annemergmed.2007.12.004. Epub 2008 Jan 28.
Results Reference
background
PubMed Identifier
22460965
Citation
Qualls ML, Mooney MM, Camargo CA Jr, Zucconi T, Hooper DC, Pallin DJ. Emergency department visit rates for abscess versus other skin infections during the emergence of community-associated methicillin-resistant Staphylococcus aureus, 1997-2007. Clin Infect Dis. 2012 Jul;55(1):103-5. doi: 10.1093/cid/cis342. Epub 2012 Mar 28.
Results Reference
background
PubMed Identifier
24620867
Citation
Singer AJ, Talan DA. Management of skin abscesses in the era of methicillin-resistant Staphylococcus aureus. N Engl J Med. 2014 Mar 13;370(11):1039-47. doi: 10.1056/NEJMra1212788. No abstract available.
Results Reference
background
PubMed Identifier
20223328
Citation
Tsoraides SS, Pearl RH, Stanfill AB, Wallace LJ, Vegunta RK. Incision and loop drainage: a minimally invasive technique for subcutaneous abscess management in children. J Pediatr Surg. 2010 Mar;45(3):606-9. doi: 10.1016/j.jpedsurg.2009.06.013.
Results Reference
background
PubMed Identifier
20638546
Citation
Ladd AP, Levy MS, Quilty J. Minimally invasive technique in treatment of complex, subcutaneous abscesses in children. J Pediatr Surg. 2010 Jul;45(7):1562-6. doi: 10.1016/j.jpedsurg.2010.03.025.
Results Reference
background
PubMed Identifier
27621209
Citation
Gaszynski R, Punch G, Verschuer K. Loop and drain technique for subcutaneous abscess: a safe minimally invasive procedure in an adult population. ANZ J Surg. 2018 Jan;88(1-2):87-90. doi: 10.1111/ans.13709. Epub 2016 Sep 12.
Results Reference
background

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Derma-Stent Novel Abscess Packing Device

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