Phase 2
N=35
Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery
Congenital Heart Defect · Surgery-Induced Tissue Adhesions · Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT01330433 ↗Enrolled (actual)
35
Serious AEs
11.4%
Results posted
Aug 2016
Primary outcome: Primary: Severity of Adhesions at the Retrosternal Site — 0; 31.3; 0; 37.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CoSeal Surgical Spray Group (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Adhesions at the Retrosternal Site |
0; 31.3; 0; 37.5; 0; 18.8 | — |
| PRIMARY Severity of Adhesions at the Arterial Base Site. |
0; 12.5; 0; 43.8; 7.1; 25.0 | — |
| PRIMARY Severity of Adhesions at the Diaphragm Site |
0; 0; 0; 85.7; 0; 14.3 | — |
| PRIMARY Severity of Adhesions at the Left Lateral Site |
0; 8.3; 0; 50.0; 0; 8.3 | — |
| PRIMARY Severity of Adhesions at the Right Lateral Site |
0; 6.3; 0; 25.0; 7.7; 50.0 | — |
| PRIMARY Post-operative Bleeding |
106.38; 108.64 | — |
| PRIMARY Adhesion Burden |
37.39; 23.44 | — |
| SECONDARY Hospital Stay |
4.75; 6.29 | — |
Summary
This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and pericardial adhesions in children undergoing staged surgical reconstruction (potential procedures include: Blalock-Taussig Type Operation, Classical Glenn Procedure, Bidirectional Glenn Procedure, Norwood). Additionally, bleeding will be evaluated by drainage post-operatively through surgical site drainage output.
Eligibility Criteria
Inclusion Criteria
- Have an acceptable surrogate capable of giving consent on the subject's behalf.
- Pediatric patients ages 0 - 17
- Have a cardiac disease which requires staged cardiac surgery and resternotomy
- Non-emergent state or emergent state with sufficient time to educate and consent
Exclusion Criteria
- An immune system disorder
- Unplanned reoperation
- Known hypersensitivity to components in CoSeal
- Patients undergoing reoperation less than 3 months after the primary surgery
Data sourced from ClinicalTrials.gov (NCT01330433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.