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Completed

NCT Number: NCT03398746

The LOOP Trial in Treatment of Skin Abscesses

This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Two methods of drainage were compared: 1) the LOOP technique or 2) standard packing technique.

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Key information

Conditions

Abscess Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Soft Tissue Infections Suppuration

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This prospective, randomized controlled trial enrolled a convenience sample of adults and children presenting to two Level 1 trauma centers over 12-months with subcutaneous skin abscesses necessitating drainage. Patients were excluded if the abscess was on the hand, foot, or face or if it required admission or operative intervention. Patients were followed over 10 days to determine the primary outcome of treatment failure defined by need for admission, IV antibiotics, or repeat drainage within 10-day follow-up. The secondary outcomes included ease of procedure, ease of care, pain after insertion and patient satisfaction using a 10-point numeric rating.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subcutaneous skin abscesses necessitating drainage

Exclusion criteria

  • Abscess was on the hand, foot, or face
  • Requiring admission or operative intervention

Treatment and study plan

LOOP Technique

Procedure

Placement of subcutaneous loop drain

Standard incision and drainage

Procedure

Incise and drain with placement of packing

Primary outcomes

  1. Treatment Failure

    Time frame: 10 Days

    Need for admission, IV antibiotics, or repeat drainage within 10-day follow-up derived from descriptive nature

Secondary outcomes

  1. Procedure Pain

    Time frame: At time of procedure

    Procedure Pain using Likert scale 1-10

  2. Ease of procedure

    Time frame: At time of procedure

    Ease of procedure using Likert 1-10 scale

  3. Ease of care

    Time frame: During 10 days

    Ease of care using 1-10 Likert scale

  4. Pain on follow-up

    Time frame: 10 days

    Pain on follow-up using 1-10 Likert scale

  5. Patient satisfaction

    Time frame: During 10 days

    Patient satisfaction using Patient derived Likert scale

Sponsors and collaborators

Lead sponsor

Orlando Regional Medical Center

Other

Registry information

Official study title

The LOOP Trial: A Study Comparing the Use of the LOOP Technique Versus Standard Incision and Drainage in the Treatment of Skin Abscesses in a Level I Emergency Department

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 12, 2018
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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