CompletedNot Applicable

Evaluating Clinical Effects of a Spray-Type Bio-absorbable Adhesion Barrier System in Paediatric Patients

Hong Kong20 participantsStarted 2022-03-01

Plain-language summary

This is a prospective randomized single-blind study where a placebo group served the control, to confirm the efficacy and safety of AdSpray™ as an inhibitory effect of postoperative adhesion formation in paediatric patients who underwent laparotomy with stoma.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients requiring laparotomy and staged operation with closure of stoma as second operation e.g. Necrotising Enterocolitis, Anorectal malformation, Hirschsprung's disease, etc. Exclusion Criteria: * A history of hypersensitivity to substances derived from corn starch * A history of surgery in the abdominal cavity or pelvic cavity accompanied by a laparotomy scar * Patients with peritonitis * Laparoscopic assessment of adhesions may not be performed safely at the second-look surgery.

What they're measuring

Incidence of adhesion

Timeframe: 6 months

Extent of adhesion

Timeframe: 6 months

Severity of adhesion

Timeframe: 6 months

Trial details

NCT IDNCT05255081

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-01

View on ClinicalTrials.gov More Surgical Adhesions trials