Incision and Loop Drainage Utilizing a Novel Technique for Management of Cutaneous Abscess in an Adult Population

Not Applicable

Withdrawn

• Conditions: Abscess; Drain Abscess
• Interventions: Device: traditional incision and drainage (I&D); Procedure: incision and loop drainage

• Registration Number: NCT04241471
• Lead Sponsor: bryan malcolm

Brief Summary

When using the rolled ring of a sterile glove as a loop drain in incision and loop drainage, is it superior to incision and drainage for treatment of a cutaneous abscess in 18 to 65 year-old patients presenting to the Emergency Department, Family Health Clinic, Family Medicine Residency Clinic, or Internal Medicine Clinic?

Hypothesis: When treating a cutaneous abscess, incision and loop drainage utilizing the rolled ring of a sterile glove as a loop drain is superior to the standard (incision and drainage) yielding a treatment failure rate of 1% at seven to ten days.

Detailed Description

Practicing medicine in an austere environment is fraught with challenges. One primary challenge is that clinicians will frequently be practicing without the supplies needed for specific indicated purpose. For treatment of a cutaneous abscess, sterile gloves are readily available whether at home or when deployed. It can be much more difficult to come across a penrose or vessel loop. In addition, follow up for wound repacking and reassessment is a struggle. Patients may have to move from location to location or have work hours that make it difficult to return to the clinic. The loop technique utilizing the rolled ring of a sterile glove solves both of these problems. Sterile gloves are always available and the Loop technique requires little to no follow up. Additional benefits include: subjects may experience less pain, improved cosmesis, faster healing, and decreased complication rates with incision and loop drainage utilizing the rolled ring of a sterile glove compared to traditional incision and drainage.

Study Timeline

• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-24
• Study First Posted: 2020-01-27
• Study Start: 2020-05-04
• Status Verified: 2021-02
• Primary Completion: 2021-02-02
• Study Completion: 2021-02-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Active Duty and DoD beneficiaries aged 18 to 65 years old.
• Abscess that requires drainage.

Exclusion Criteria

• Abscess of the hand, foot, or face, immunocompromised by disease or medications.
• Temperature greater than 100.4 degrees Fahrenheit.
• Systolic blood pressure less than 90 mmHG.
• Abscess is too small to treat with incision and drainage (as seen on ultrasound).
• Patient is too ill to be included in the study determined by clinical judgement of the treating provider.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditional incision and drainage (I&D)	traditional incision and drainage (I&D)	-
incision and loop drainage	incision and loop drainage	incision and loop drainage utilizing the rolled ring of a sterile glove technique

Primary Outcome Measures

Name	Time	Method
Provider satisfaction: Visual Analogue Scale	post-procedure	Data will be collected using the VAS. Provider mark will be measured in millimeters and recorded.; Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. In this case, higher scores mean a better outcome (satisfaction) and lower scores mean less satisfaction.
Number of subjects with Treatment effectiveness	30 days post-procedure	A record review will be performed to identify patients that had to return to the Emergency Department up to 30 days after the procedure due to complications. Attempts will be made to contact patients who fail to follow up. If unable to contact, a record review will be conducted in attempt to ascertain abscess status. If these measures are unsuccessful, patient treatment will be considered a success.; Record Review: Treatment failure will be defined as need for repeat drainage, intravenous antibiotic, hospitalization or surgical treatment within 7 days.
Subject pain: Visual Analogue Scale	Pre-procedure, mid-procedure, post-procedure	Data will be collected using the VAS. Patients mark will be measured in millimeters and recorded.; Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Lower scores mean a better outcome and higher scores mean greater pain severity.
Subject satisfaction: Visual Analogue Scale	7-10 day follow-up	Data will be collected using the VAS. Subject mark will be measured in millimeters and recorded.; Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. In this case, higher scores mean a better outcome (satisfaction) and lower scores mean less satisfaction.