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

February 3, 2021 updated by: bryan malcolm

Incision and Loop Drainage Utilizing a Novel Technique for Management of Cutaneous Abscess in an Adult Population: A Randomized Control Trial

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.

Study Overview

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: traditional incision and drainage (I&D)
traditional incision and drainage (I&D)
Experimental: incision and loop drainage
incision and loop drainage utilizing the rolled ring of a sterile glove technique
incision and loop drainage utilizing the rolled ring of a sterile glove technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with Treatment effectiveness
Time Frame: 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.

30 days post-procedure
Subject pain: Visual Analogue Scale
Time Frame: 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.

Pre-procedure, mid-procedure, post-procedure
Provider satisfaction: Visual Analogue Scale
Time Frame: 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.

post-procedure
Subject satisfaction: Visual Analogue Scale
Time Frame: 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.

7-10 day follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2020

Primary Completion (Actual)

February 2, 2021

Study Completion (Actual)

February 2, 2021

Study Registration Dates

First Submitted

January 22, 2020

First Submitted That Met QC Criteria

January 24, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

We do not plan on sharing data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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