Loop Drainage: Effectiveness in Treating Cutaneous Abscesses

Abscess of Skin and/or Subcutaneous Tissue Clinical Trial

Official title:

Evaluation of Loop Drainage Technique Versus Standard Incision and Drainage for Treatment of Simple Soft Tissue Abscesses

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02697279
• Other study ID #: HP-00066974
• Status: Terminated
• Phase: N/A
• Start date: October 2016
• Est. completion date: February 1, 2018

Study information

• Verified date: December 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the Emergency Department (ED), patients frequently seek medical treatment for cutaneous abscesses. Traditional incision and drainage (I&D), with or without packing of cutaneous abscesses has long been the accepted standard of care. This procedure is often very painful for the patient. Additionally, compliance with wound care and follow-up can present barriers to proper care and healing. Research has suggested that incision and loop drainage of an abscess may be another effective treatment for simple cutaneous abscess. Thus far, research into this procedure has been limited to the pediatric population with small sample sizes. In these previous studies, this technique was found to be an effective and less painful treatment for abscesses. Research has not been done in the adult population using this procedure. If this procedure is found to be as effective and less painful in the adult population, then it should be considered as a potential preferred I&D method for cutaneous abscess in the ED.

Description:

Patients who meet study criteria for treatment of a simple cutaneous abscess and desire to be a part of this study, will be consented. Study subjects will be enrolled and randomly assigned to either the study or control groups. Control Group- standard I & D method for cutaneous abscess. Study Group- Loop Technique: 1. Gather all of your material and bring to bedside 2. Clean area with chlorhexidine or iodine swabs 3. Anesthetize area 4. Use your scalpel to make small 5mm incision at most fluctuant area of abscess 5. Explore cavity with your hemostat and break down loculations 6. Make second incision less than 4cm away from first incision. Feel borders of abscess, and try to make second incision as far within cavity as you can. 7. For larger abscesses can repeat step 5 thus creating several LOOPs. 8. Irrigate cavity with saline flush 9. Pass hemostat through both incisions and pull loop vessel, penrose, or bottom of glove through. Keep your loop device equal in length on both sides. 10. Tie loop device loosely over 30cc syringe to form LOOP. Usually 5-6 knots. This helps prevent loop from falling out prematurely. 11. Slide syringe out, and trim free ends of loop. Make sure loop is mobile. 12. Cover site with dry dressing. Follow-Up- - Wound check in 1-2 days - Patient may manage drain at home by rotating it to facilitate drainage and prevent adhesion - Patient will be instructed to return to the Emergency Department for drain removal in 5-7 days.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years or older

2. Presents to ED with simple cutaneous abscess

3. Provides informed consent.

Exclusion Criteria:

1. Under 18 years of age

2. Abscess too small for performance of procedure

3. Signs of systemic infection

4. Need for hospitalization

5. Previously treated for current abscess

6. Clinician determines abscess would not be amenable to drainage by loop technique

7. Patients known to be pregnant

8. Incarcerated patients

9. Students / Employees of the facility

10. Presence of any other condition(s) that the investigator feels makes the patient unsuitable for study inclusion.

Related Conditions & MeSH terms

• Abscess
• Abscess of Skin and/or Subcutaneous Tissue

Intervention

Procedure:
• Traditional Incision and Drainage.
Control Group- Standard treatment of a simple cutaneous abscess with traditional I&D technique with or without packing utilizing a standard I&D kit.
• Loop drainage
Study Group- Treatment of a simple cutaneous abscess with the loop drainage technique utilizing an standard I&D kit and the cuff of a sterile glove for a loop device.

Locations

Country	Name	City	State
United States	University of Maryland Medical Systems	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (7)

Kushnir VA, Mosquera C. Novel technique for management of Bartholin gland cysts and abscesses. J Emerg Med. 2009 May;36(4):388-90. doi: 10.1016/j.jemermed.2008.05.019. Epub 2008 Nov 26. — View 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. — View Citation

Ladde JG, Baker S, Rodgers CN, Papa L. The LOOP technique: a novel incision and drainage technique in the treatment of skin abscesses in a pediatric ED. Am J Emerg Med. 2015 Feb;33(2):271-6. doi: 10.1016/j.ajem.2014.10.014. Epub 2014 Oct 16. — View Citation

McNamara WF, Hartin CW Jr, Escobar MA, Yamout SZ, Lau ST, Lee YH. An alternative to open incision and drainage for community-acquired soft tissue abscesses in children. J Pediatr Surg. 2011 Mar;46(3):502-6. doi: 10.1016/j.jpedsurg.2010.08.019. — View Citation

Taira BR, Singer AJ, Thode HC Jr, Lee CC. National epidemiology of cutaneous abscesses: 1996 to 2005. Am J Emerg Med. 2009 Mar;27(3):289-92. doi: 10.1016/j.ajem.2008.02.027. — View Citation

Thompson DO. Loop drainage of cutaneous abscesses using a modified sterile glove: a promising technique. J Emerg Med. 2014 Aug;47(2):188-91. doi: 10.1016/j.jemermed.2014.04.035. Epub 2014 Jun 11. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure failure rate	Determining the difference in failure rates between the study group and control group. Treatment failure is a composite outcome defined as having the presence of any of the following: requiring a 2nd incision and drainage procedure, a patient that requires administration of antibiotics after the initial treatment period due to worsening clinical status, a patient that requires hospitalization after the initial treatment period due to worsening clinical status.	5 -7 days after procedure
Secondary	Difference in pain associated with the procedure using a visual analog pain scale	To evaluate the difference in pain between the experimental and control groups associated with the procedure using a visual analog pain scale (0-100).	Measured after the procedure on day 1
Secondary	Patient Satisfaction using a visual analog pain scale	To measure the difference in patient satisfaction with overall treatment between the study and control groups using the visual analog scale (0-100).	5-7 days after procedure