Status:
COMPLETED
Evaluating Clinical Effects of a Spray-Type Bio-absorbable Adhesion Barrier System in Paediatric Patients
Lead Sponsor:
The University of Hong Kong
Conditions:
Surgical Adhesions
Eligibility:
All Genders
Up to 18 years
Phase:
NA
Brief 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...
Detailed Description
Postoperative adhesions are fibrovascular bands connecting the parietal peritoneum to the visceral peritoneum of intra-abdominal organs, or connecting intra-abdominal organs to one another, which deve...
Eligibility Criteria
Inclusion
- Patients requiring laparotomy and staged operation with closure of stoma as second operation e.g. Necrotising Enterocolitis, Anorectal malformation, Hirschsprung's disease, etc.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05255081
Start Date
March 1 2022
End Date
April 30 2024
Last Update
May 8 2024
Active Locations (1)
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1
Department of Surgery, University of Hong Kong
Hong Kong, Hong Kong, 0000