An interventional study of Ultrasound-guided Needle Aspiration Procedure and Incision and Drainage (I&D) in Skin Abscess, sponsored by Wayne State University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-19.
Sponsored by Wayne State University · Not applicable, Interventional, and Treatment
Incision and drainage (I\&D) is the standard guideline treatment of uncomplicated skin abscesses (a boil or bumo beneath the skin). Ultrasound-guided needle aspiration (USGNA) is a minimally invasive and less painful alternative treatment, but has not been validated as non-inferior to I\&D. Multiple studies have shown successful treatment with USGNA of breast, face, neck, and/or trunk abscesses in combination with oral antibiotics with success rates as high as 97%.
In 2011 Gaspari et al. published a landmark article on the use of USGNA for skin abscesses. In this randomized controlled trial, USGNA and I\&D had failure rates of 74% and 20% respectively, which makes USGNA an unappealing treatment option. However, the study had several methodological issues that likely biased the results in favor of I\&D, including the following: 1) aspiration was performed with an 18-gauge needle which is often too small to aspirate thick purulence (or pus); 2) failure to fully aspirate all abscess contents was a priori defined as treatment failure rather than strictly clinical outcomes; 3) the abscess aspiration procedure was not standardized; and 4) post-intervention oral antibiotic therapy was not used on all patients.
The main hypothesis is that a modified protocol of the Gaspari et al. USGNA study to address these flaws will demonstrate a failure of USGNA comparable to I\&D for the treatment of uncomplicated skin abscesses. First, the study will standardize the use of larger 14-gauge needle on all USGNAs. Second, USGNA intervention failure need not be defined as the inability to completely aspirate all abscess cavity contents under ultrasound guidance. Previous studies have demonstrated clinical success with USGNA of skin abscesses without applying the rigid failure criteria chosen by Gaspari et al. There is only one study in the literature to suggest that there is no correlation between a small quantity of residual abscess contents post-USGNA and ultimate clinical failure, however, there are no studies which specifically address this clinical question. In this study, initial treatment failure of USGNA will be defined as the inability to aspirate any purulent material. Third, treatment outcomes in this study will be determined by clinical resolution of abscess at the study endpoint of 7-10 days, which is a well-established timeline for anticipated abscess healing and endpoint clinical follow-up. Fourth, ultrasound fellowship-trained emergency physicians will perform USGNA in standardized fashion on all enrolled patients. Lastly, post-intervention oral antibiotic with methicillin-resistant Staphylococcus aureus (MRSA) coverage will be provided and compliance closely monitored throughout the study.
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This study's planned enrollment of 40 is below the median of 96 across 102 interventional studies indexed under Abscess.
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Exclusion Criteria:
The abscess cavity will be evaluated thoroughly with ultrasonography. The site will be prepared and draped. The skin surface will be infiltrated with local anesthetic with a 25-gauge needle. The treating clinician may provide ultrasound-guided regional anesthesia for procedural analgesia at their discretion. Incision of the skin surface with a number 11-blade scalpel will be performed over the largest area of infection; the incision will be extended into the abscess cavity. A blunt instrument will then be used to break up internal loculations if present. Repeated instrumentation through the initial incision or extension of the original incision will be performed if needed. Lastly, iodoform packing will be inserted through the incision into the cavity. The decision to send the abscess contents for microbiological culture and susceptibility analysis will be at the discretion of the treating clinician.
Procedure: Incision and Drainage (I&D)
The abscess cavity will be evaluated thoroughly with US. The site will be prepared and draped. The skin surface and anticipated needle track will be infiltrated with local anesthetic with a 25g needle. The treating clinician may provide ultrasound-guided regional anesthesia for procedural analgesia at their discretion. Under direct US-guided visualization, a 14g 2in steel needle attached to a 40mL syringe will be advanced into the abscess cavity with manual negative pressure. The needle tract will be extended obliquely 2-3 cm between the skin and abscess to prevent fistulization. Purulent material will be aspirated until no further purulence can be aspirated. Multiple aspiration attempts on the initial visit will be permitted to maximally drain the abscess cavity. Additionally, irrigation of the abscess cavity with sterile saline will be permitted to break up internal loculations if present, as has reported previously for trunk and breast abscesses.
Procedure: Ultrasound-guided Needle Aspiration Procedure
The intervention under investigation utilizes an ultrasound-guided needle to less invasively drain an abscess.
The current standard procedure to drain an abscess of purulent material.
Abscess cure or treatment failure
Treatment cure will be defined by the complete resolution of the abscess based on clinical signs and symptoms (no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance, or induration) at the 7- to 10-day follow-up. Treatment failure will be defined by: fever (attributable to the infection), persistent or increased size \>25% of the original abscess, requiring conversion to I\&D (USGNA intervention group) or repeat I\&D (I\&D intervention group), requiring additional antibiotics, or requiring hospital admission within 7-10 days after treatment. Participants who either withdraw from the trial or are lost to follow-up before a determination of final outcome will be classified as treatment failure.
Time frame: 7-10 days
Patient Satisfaction
Patient satisfaction with each procedural intervention will be assessed, with the hypothesis that USGNA will have higher overall satisfaction rates than I\&D.
Time frame: Baseline (Day 1)
Patient Comfort Level
Patient comfort for each procedural intervention will be assessed , with the hypothesis that USGNA will have lower overall pain scores compared to I\&D.
Time frame: Baseline (Day 1)
Abscess Characteristics and Correlation with Treatment Failure
Assessment of whether specific abscess characteristics have any correlation to procedural failure in either intervention group.
Time frame: Baseline (Day 1)
Abscess Reoccurrence
The cumulative rate of abscess recurrence will be assessed at the 21- to 30-day follow-up.
Time frame: Day 21-30
Abscess Site infection
Infections involving the same site at the 21- to 30-day follow-up will be considered a recurrent infection.
Time frame: Day 21-30
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Wayne State University