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

B

bryan malcolm

Status

Withdrawn

Conditions

Drain Abscess
Abscess

Treatments

Procedure: incision and loop drainage
Device: traditional incision and drainage (I&D)

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT04241471
FWH20200046H

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

**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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

traditional incision and drainage (I&D)
Active Comparator group
Treatment:
Device: traditional incision and drainage (I&D)
incision and loop drainage
Experimental group
Description:
incision and loop drainage utilizing the rolled ring of a sterile glove technique
Treatment:
Procedure: incision and loop drainage

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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