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

NCT05255081 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-05-08

No results posted yet for this study

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.

Conditions

  • Surgical Adhesions

Interventions

DEVICE

Adspray

Application of AdSpray™ over all organs under the laparotomy incision at the end of operation

PROCEDURE

Placebo-control

Spray with saline would be applied to organs under incision

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Adrian Chi Heng Fung, MBBS · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-03-01
Completion
2024-04-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05255081 on ClinicalTrials.gov