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

NCT05255081 | Completed

• 1 other identifier: PEARLTrial
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 in paediatric patients who underwent laparotomy with stoma.

Conditions

Surgical Adhesions

Keywords

Paediatric surgery; surgical adhesions; medical device; biodegradable anti-adhesive agent

Outcome Measures

Primary Outcomes (3)

• Incidence of adhesion

  The number of participants developed adhesion during the study period at the second operation assessment

  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

  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

  6 months

Secondary Outcomes (1)

• Adverse events

  6 months

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Device: Adspray

Control Arm

PLACEBO COMPARATOR

Spray with saline would be applied to organs under incision

Procedure: Placebo-control

Interventions

Adspray DEVICE

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

Treatment Arm

Placebo-control PROCEDURE

Spray with saline would be applied to organs under incision

Control Arm

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients requiring laparotomy and staged operation with closure of stoma as second operation e.g. Necrotising Enterocolitis, Anorectal malformation, Hirschsprung's disease, etc.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Surgery, University of Hong Kong

Hong Kong, 0000, Hong Kong

Location

Related Publications (8)

• Thakur M, Rambhatla A, Qadri F, Chatzicharalampous C, Awonuga M, Saed G, Diamond MP, Awonuga AO. Is There a Genetic Predisposition to Postoperative Adhesion Development? Reprod Sci. 2021 Aug;28(8):2076-2086. doi: 10.1007/s43032-020-00356-7. Epub 2020 Oct 22.

  PMID: 33090376 BACKGROUND

• Foster DS, Marshall CD, Gulati GS, Chinta MS, Nguyen A, Salhotra A, Jones RE, Burcham A, Lerbs T, Cui L, King ME, Titan AL, Ransom RC, Manjunath A, Hu MS, Blackshear CP, Mascharak S, Moore AL, Norton JA, Kin CJ, Shelton AA, Januszyk M, Gurtner GC, Wernig G, Longaker MT. Elucidating the fundamental fibrotic processes driving abdominal adhesion formation. Nat Commun. 2020 Aug 13;11(1):4061. doi: 10.1038/s41467-020-17883-1.

  PMID: 32792541 BACKGROUND

• Lakshminarayanan B, Hughes-Thomas AO, Grant HW. Epidemiology of adhesions in infants and children following open surgery. Semin Pediatr Surg. 2014 Dec;23(6):344-8. doi: 10.1053/j.sempedsurg.2014.06.005. Epub 2014 Jun 4.

  PMID: 25459439 BACKGROUND

• Nguyen ATM, Holland AJA. Paediatric adhesive bowel obstruction: a systematic review. Pediatr Surg Int. 2021 Jun;37(6):755-763. doi: 10.1007/s00383-021-04867-5. Epub 2021 Apr 19.

  PMID: 33876300 BACKGROUND

• Inoue M, Uchida K, Otake K, Nagano Y, Ide S, Hashimoto K, Matsushita K, Koike Y, Mohri Y, Kusunoki M. Efficacy of Seprafilm for preventing adhesive bowel obstruction and cost-benefit analysis in pediatric patients undergoing laparotomy. J Pediatr Surg. 2013 Jul;48(7):1528-34. doi: 10.1016/j.jpedsurg.2013.01.028.

  PMID: 23895967 BACKGROUND

• Kai M, Maeda K, Tasaki M, Kira S, Nakamura S, Chino N, Hagiwara H, Nishida H, Kawanishi T. Evaluation of a Spray-type, Novel Dextrin Hydrogel Adhesion Barrier Under Laparoscopic Conditions in a Porcine Uterine Horn Adhesion Model. J Minim Invasive Gynecol. 2018 Mar-Apr;25(3):447-454. doi: 10.1016/j.jmig.2017.09.023. Epub 2017 Oct 10.

  PMID: 29030291 BACKGROUND

• Suto T, Watanabe M, Endo T, Komori K, Ohue M, Kanemitsu Y, Itou M, Takii Y, Yatsuoka T, Shiozawa M, Kinugasa T, Ueno H, Takayama T, Masaki T, Masuko H, Horie H, Inomata M. The Primary Result of Prospective Randomized Multicenter Trial of New Spray-Type Bio-absorbable Adhesion Barrier System (TCD-11091) Against Postoperative Adhesion Formation. J Gastrointest Surg. 2017 Oct;21(10):1683-1691. doi: 10.1007/s11605-017-3503-1. Epub 2017 Jul 25.

  PMID: 28744742 BACKGROUND

• Cezar C, Korell M, Tchartchian G, Ziegler N, Senshu K, Herrmann A, Larbig A, De Wilde RL. How to avoid risks for patients in minimal-access trials: Avoiding complications in clinical first-in-human studies by example of the ADBEE study. Best Pract Res Clin Obstet Gynaecol. 2016 Aug;35:84-96. doi: 10.1016/j.bpobgyn.2015.11.004. Epub 2015 Nov 14.

  PMID: 26707194 BACKGROUND

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adrian Chi Heng Fung, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: After completion of necessary operative procedures in the primary operation, barrier agent (AdSpray™or Placebo) will be sprayed to fully cover the organs under the laparotomy incision. At the second-look surgery, laparoscopic video recordings of the area under the laparotomy incision will be made in both groups. For the efficacy evaluation, based on the laparoscopic images of the abdominal cavity at the time of the second-look surgery, the presence, extent, and severity of adhesions will be assessed by the adhesion-assessment team which is independent of the study. The independent adhesion-assessment team will assess the extent and severity of adhesions under the laparotomy incision on a 4-grade scale.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible subjects will be identified, and parents will be approached for patient recruitment. Once consent to participation is signed, the patients will be randomised into either treatment group (AdSpray™) or placebo-controlled group in 1:1 ratio using simple randomization. The adhesion-assessment team will be blinded to the group allocated. The spray will be prepared according to the group allocated by a dedicated scrub nurse. For treatment group, AdSpray™ will be instilled into the drug chamber; for placebo group, saline will be instilled instead.

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 24, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: April 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)