CompletedPhase 4ACTRN12626000388314

Therapeutic outcome of incision and drainage of subcutaneous abscess with or without use of antibiotics in the pediatric population.


Sponsor

National Institute of child Health Karachi

Enrollment

124 participants

Start Date

Jun 7, 2025

Study Type

Interventional

Conditions

Summary

This study evaluates the outcome of incision and drainage of subcutaneous abscesses in children with and without the use of antibiotics. Children will receive either postoperative antibiotics or wound care alone after the procedure. The study aims to determine whether antibiotics improve recovery or reduce recurrence after incision and drainage


Eligibility

Sex: Both males and femalesMin Age: 1 YearsMax Age: 12 Yearss

Inclusion Criteria4

  • Age 1–12 years.
  • Male or female.
  • Presenting with a subcutaneous abscess meeting the operational definition: localized, fluctuant swelling 2–6 cm in greatest dimension with overlying erythema and warmth.
  • Caregiver able and willing to provide informed consent and to attend follow-up on day 7.

Exclusion Criteria8

  • Children with a recent history of antibiotic intake (within the last 7 days), verified through medical records or caregiver report.
  • Known cases of congenital immunodeficiency disorders, confirmed from medical records.
  • Presence of any systemic illness such as diabetes mellitus, chronic renal disease, congenital heart disease, or malignancy
  • Children with severe malnutrition, as per WHO criteria (weight-for-height Z-score = -3 SD or presence of nutritional edema).
  • Presence of multiple abscesses on the body.
  • Known hypersensitivity or allergy to co-amoxiclav.
  • Abscess size less than 2 cm or greater than 6 cm in greatest dimension.
  • Abscess located in perineal, perianal, or paronychial regions.

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Interventions

Children aged 01 years to 12 years presenting with a subcutaneous abscess measuring more than 2 cm and less than 6 cm in diameter will undergo incision and drainage (I&D) under aseptic conditions in t

Children aged 01 years to 12 years presenting with a subcutaneous abscess measuring more than 2 cm and less than 6 cm in diameter will undergo incision and drainage (I&D) under aseptic conditions in the minor operation theater. The procedure will take approximately 20–30 minutes. After incision and drainage, children in the intervention group will be prescribed oral amoxicillin–clavulanic acid at a dose of 30–50 mg/kg/day, divided into three doses (three times daily [TDS]), for a duration of 5 days. Daily wound dressing will be performed by a registered nurse. Adherence to the intervention will be assessed through review of medical records and followup visits


Locations(1)

Sindh, Pakistan

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ACTRN12626000388314