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

NCT ID: NCT04241471

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-04
• Study Completion Date: 2021-02-02

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.

Conditions

Abscess; Drain Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

traditional incision and drainage (I&D)

Group Type: ACTIVE_COMPARATOR

traditional incision and drainage (I&D)

Intervention Type: DEVICE

traditional incision and drainage (I\&D)

incision and loop drainage

incision and loop drainage utilizing the rolled ring of a sterile glove technique

Group Type: EXPERIMENTAL

incision and loop drainage

Intervention Type: PROCEDURE

incision and loop drainage utilizing the rolled ring of a sterile glove technique

Interventions

incision and loop drainage

incision and loop drainage utilizing the rolled ring of a sterile glove technique

Intervention Type: PROCEDURE

traditional incision and drainage (I&D)

traditional incision and drainage (I\&D)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

bryan malcolm

FED

Sponsor Role: lead

Responsible Party

bryan malcolm

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paul F Crawford, MD

Role: STUDY_DIRECTOR

United States Air Force

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Related Links

https://baylor.primo.exlibrisgroup.com/discovery/fulldisplay?docid=wos000445699100183&context=PC&vid=01BUL_INST:BAYLOR&lang=en&search_scope=MyInst_and_CI&adaptor=Primo%20Central&tab=Everything&query=any,contains,incision%20and%20loop%20drainage&offset=0.

loop drainage

Other Identifiers

FWH20200046H

Identifier Type: -

Identifier Source: org_study_id