A Phase 4 interventional study of LMX 4 Topical Cream in Cutaneous Abscess, sponsored by Rush University Medical Center. Withdrawn at 1 site in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by Rush University Medical Center · Phase 4, Interventional, and Treatment
This is a single center non-blinded randomized trial of topical anesthetic cream to usual care (warm compresses and time) for superficial, non-perianal abscesses in children under 18 years of age. The primary outcome is time to spontaneous drainage. The secondary outcomes are return to emergency room/hospital/care provider and need for incision and drainage. Information on patient experience using standardized patient reported outcome measures for health-related quality of life will also be gathered. The findings of this study will provide more robust evidence of the benefit of this treatment including a potential reduction in cost and allow for more widespread dissemination.
Cutaneous abscesses are a common problem in the pediatric population, leading to a substantial number of emergency room and primary care visits each year. Historically, treatment consisted of antibiotics and surgical drainage, but as our understanding of these disease processes has progressed, treatment has moved away from invasive drainage procedures except when necessary. Now, most patients are treated with warm compresses or warm baths to the area until spontaneous resolution occurs. Recent data has demonstrated that the application of topical anesthetic cream to a cutaneous abscess underneath a non-permeable dressing can lead to improved rates of spontaneous drainage. Although this method is being used with success at our institution, its true benefit is unknown, preventing widespread dissemination of the practice. We are therefore proposing a prospective trial to evaluate the benefit of this treatment on pediatric patients. This is a single center non-blinded randomized trial of topical anesthetic cream to usual care (warm compresses and time) for superficial, non-perianal abscesses in children under 18 years of age. The primary outcome is time to spontaneous drainage. The secondary outcomes are return to emergency room/hospital/care provider and need for incision and drainage. Information on patient experience using standardized patient reported outcome measures for health-related quality of life will also be gathered. The findings of this study will provide more robust evidence of the benefit of this treatment including a potential reduction in cost and allow for more widespread dissemination.
152 studies on the registry are indexed under Abscess; 22 are open to participants now.
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Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
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Exclusion Criteria:
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The control group will receive instructions on applying warm compresses, the current standard of care. The patient or parent/guardian will be directed to apply a warm compress to the abscess or soak the area in warm water for 15 minutes. The application/soak will be done 4 times during the day.
The intervention group will be prescribed a course of LMX4 with application of a non-permeable dressing (Tegaderm, 3M, St Paul, MN) until time of spontaneous drainage, treatment failure, or resolve of pain. LMX4 is a topical anesthetic consisting of 4% lidocaine which is Food and Drug Administration (FDA) approved for topical use in children.
Drug: LMX 4 Topical Cream
The intervention group will be prescribed a course of LMX4 with application of a non-permeable dressing (Tegaderm, 3M, St Paul, MN) until time of spontaneous drainage, treatment failure, or resolve of pain. LMX4 is a topical anesthetic consisting of 4% lidocaine which is Food and Drug Administration (FDA) approved for topical use in children.
Also known as: lidocaine
Time to Spontaneous Discharge
Patient/Caregiver will be called to learn date of spontaneous discharge
Time frame: Enrollment + 7-14 Days
Rate of Failure
Study team will review medical records for hospital admission, need for incision and drainage, or additional medication treatment
Time frame: Enrollment + 30 Days
Pain Interference PROMIS Pediatric Item Bank v2.0 - Pain Interference - Short Form 8a
PROMIS Pediatric Item Bank v2.0 - Pain Interference - Short Form 8a, range 8-40, lower score better
Time frame: Enrollment + 7-14 Days
Pain Interference PROMIS Pediatric Item Bank v2.0 - Pain Interference
PROMIS Pediatric Item Bank v2.0 - Pain Interference, range 20-100, lower score better
Time frame: Enrollment + 7-14 Days
Pain Interference PROMIS Parent Proxy Item Bank v2.0 - Pain Interference - Short Form 8a
PROMIS Parent Proxy Item Bank v2.0 - Pain Interference - Short Form 8a, range 8-40, lower score better
Time frame: Enrollment + 7-14 Days
Pain Interference PROMIS Parent Proxy Item Bank v2.0 - Pain Interference
PROMIS Parent Proxy Item Bank v2.0 - Pain Interference, range 13-65, lower score better
Time frame: Enrollment + 7-14 Days
Global Health PROMIS Pediatric Scale v1.0 - Global Health 7+2
PROMIS Pediatric Scale v1.0 - Global Health 7+2, range 9-45, lower score better
Time frame: Enrollment + 7-14 Days
Global Health PROMIS Parent Proxy Scale v1.0 - Global Health 7+2
PROMIS Parent Proxy Scale v1.0 - Global Health 7+2, range 9-45, lower score better
Time frame: Enrollment + 7-14 Days
Start is estimated for Jan 2025; primary completion for Jan 2026, 12 months later.
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Studies of the drug tested here: Lidocaine
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