An interventional study of Adspray and Placebo-control in Surgical Adhesions, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Prevention
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.
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 developed unavoidably following virtually all body cavity surgeries. Adhesions affect up to 80-93% of patients following abdominal surgery. Being the leading cause of postoperative small bowel obstruction, it could potentially cause other enormous clinical problems including difficulty in subsequent operations, infertility, and chronic pain. The incidence of adhesion-related morbidity is estimated to be 2.2% to 19.5% in the pediatric population, among which large proportion of patients required subsequent surgical intervention. A variety of techniques and products (e.g. bioresorbable physical barrier agents, pharmacological adjuncts, etc) have been advocated for preventing postoperative adhesion formation. However, to date, no single treatment is proven to be effective and adhesions still remain a significant, unresolved postoperative complication both in adults and paediatric populations.
To reduce postoperative adhesions, Terumo Corporation (Tokyo, Japan) has developed an adhesion barrier system (AdSpray™; Terumo Corporation, Tokyo, Japan) which is easy to use at the treatment site in various surgical procedures. Its ability of adhesion prevention had been demonstrated in porcine model study. Cezar et al and Suto et al subsequently published two human prospective randomized controlled trials on the use of this barrier system in adult patients undergoing gynaecological and gastrointestinal operations, which confirmed its safety and efficacy. However, to date, studies on the use of anti-adhesion agents in children are scarce and there is no study on this novel barrier system (AdSpray™) in children. In view of this, we plan to conduct 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.
B. Study objective To investigate the effect of a novel spray-type, novel dextrin hydrogel adhesion barrier (AdSpray™; Terumo Corporation, Tokyo, Japan) on postsurgical adhesions.
C. Study design and methods This is a prospective, single center, single-blinded randomized controlled trial using a parallel arm design and placebo group as the control. Patient enrollment will start in March 2022 and expected to end in 2023.
241 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 184 interventional studies indexed under Tissue Adhesions.
Browse Tissue Adhesions studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Application of AdSpray™ over all organs under the laparotomy incision at the end of operation
Device: Adspray
Spray with saline would be applied to organs under incision
Procedure: Placebo-control
Application of AdSpray™ over all organs under the laparotomy incision at the end of operation
Spray with saline would be applied to organs under incision
Incidence of adhesion
The number of participants developed adhesion during the study period at the second operation assessment
Time frame: 6 months
Extent of adhesion
Extent of adhesion is classified into 4 grade: Grade 0 - none, Grade 1 - adhesion less than 1/3 the length of incision, Grade 2 - adhesions between 1/3 and \<2/3 the length of the incision, Grade 3 - Adhesion great or equal than 2/3 the length of the incision
Time frame: 6 months
Severity of adhesion
Severity of adhesion is classified into 4 grade: Grade 0 - none, Grade 1 - film-like with no neovascularisation, Grade 2 - moderately thick with partial neovascularisation, Grade 3 - thick, solid adhesion with neovascularisation
Time frame: 6 months
Adverse events
Intestinal obstruction, abscess, peritonitis, surgical wound infection, malfunction of device, etc.
Time frame: 6 months
Plan to share: No
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong