Comparison of two methods of pus removal in children and the success of procedure relation with microrganisms

Phase 4

Recruiting

• Conditions: Cutaneous abscess, furuncle and carbuncle, unspecified,

• Registration Number: CTRI/2020/01/022879
• Lead Sponsor: All India Institute of Medical Sciences Raipur

Brief Summary

**Background:** Traditionally pediatric soft tissue abscess is treated by Incision and drainage (I&D). **E**vidence suggests primary closure of abscess after I&D is safe and results in faster healing. USG-TCA of abscess is recommended for deep seated solid organ abscess.  We want to compare the therapeutic role of minimal invasive USG-TCA and I&D in uncomplicated pediatric SSTA.  As severity of toxicity of S aureos is related to production of PVL toxin, which would affect our results so, we would also like to asses status of PVL toxin in our cases. This study would be the first study in the literature on pediatric patients comparing the outcome of both procedures and their correlation with S aureous associated PVL toxin.

**Novelty:** There would be paradigm shift in management of uncomplicated pediatric SSTA from extremely painful I&D to less painful USG-TCA.Further advantages of USG-TCA are no incision, no repeated packing, no anesthesia,  less hospital stay, better cosmetic outcome, less superimposed infection, better parents satisfaction.

**Objective:** To compare the cure rates of uncomplicated pediatric SSTA via US-TCA  and standard I&D in especial reference to PVL toxin producing S aureous organism. To prepare local antibiogram for prophylactic antibiotics. Also to find local prevalence of Staph aureous (MSSA, CA-MRSA and HA-MRSA) in  SSTA at our centre.

**Methods:** Non blinded parallal Randomized Control trial comparing two interventions (Treatment I : USG-TCA, Treatment II: Standard Incision and Drainage)  attertiary referral centre. Total 100 patients would be recruited for number needed to treat analysis is required for the study over 1 yrs  Based on inclusion criteria’s patients aged 1 month-14 yrs would be randomized in 2 group.

PusCulture sensitivity with testing for Staph aureous producing PVLtoxinwould be  done via Enzyme linked immunosorbant (ELISA for PVL toxin)  in S aureous  isolates.

Follow up at  48 hours, 7 days and 1 month would be done for cure and recurrence.

Ifbaseline fever persisting/increasing, vital parameters detoriation, counts or features of Multiple organ failure syndrome (MODS) or Severe Inflammatory response syndrome (SIRS) appear, we would terminate participants from study and treat them according to conventional methods.

**Expected outcome:** Assuming relatively soft tissue, thin dermis, different immune status and response of injury in pediatric patients, degree of loculation in the pediatric abscess cavity is less and aspiration might have better or comparable results than I&D.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-20
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Abscesses size (equal or more than 10 CC volume with freely mobile internal echoes ) 2.Abscess confines to epidermis and dermis (USG reveled no deep fascia invasion) 3.USG does not reveled satellite lesions around index abscess (as high chance of recurrence may bias our results) 4.No known Immunocompromised status (viz HIV, Diabetes mellitus, End stage Renal disease, Chemotherapy, radiotherapy, chronic steroid usage).
• 5.No active discharge or history of discharge from surface of abscess.

Exclusion Criteria

• 1.Other soft tissue infections eg Papule and pustules (no aspirable pus) 2.Deep tissue infection (presence of pus below dermis, muscles ) 3.Suspected cold abscess (tubercular abscess).
• 4.USG reveled cavity less that 10 cc.
• 5.USG assessment reveled resolving Abscess or thick viscous pus that cannot be aspirable.
• 6.Systematic features suggestive of end organ failure e.
• Multi organ dysfunction syndrome (MODS) or features of staphylococcal scalded skin syndrome (SSSY) and Toxic Shock syndromes (TSS)}.
• 7.Patient at the time of diagnosis has clinical or radiological features of established infective endocarditis, brain abscess, meningitis or pneumonia,and osteomylitis 8.Odontogenic abscess 9.Hydranitis suppurativa (acute on chronic skin infection in rubbing hairy skin e.g. axilla, groin) 10.Paronychia (No aspiration possible).
• 11.Abscess at scalp, hand and feet, neck (multiple facial compartment so high probability of incomplete aspiration) 12.Genital abscess (more probability of anaerobic and Gram negative) 13.Perianal abscess (more probability of anaerobic and Gram negative) 14.Immunocompromised states (viz HIV, Diabetes mellitus, End stage Renal disease, Chemotherapy, radiotherapy, chronic steroid usage) 15.No consent for enrolment in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cure rate of abscess in proportions	day 2 day 7 and 1 month

Secondary Outcome Measures

Name	Time	Method
Analgesic requirement, Hospital stay, Cosmetic appearance, Parents satisfaction	12 hrs 24 hrs day 2 day 7 and 1 month

Trial Locations

Locations (1)

All India Institute of Medical Sciences Raipur; 🇮🇳 Raipur, CHHATTISGARH, India

All India Institute of Medical Sciences Raipur

🇮🇳Raipur, CHHATTISGARH, India

Sunita Singh

Principal investigator

8518881733

drsunitasingh28@gmail.com