Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Effects of CoSeal in Reducing Perioperative Bleeding & Adhesions in Pediatric Heart Surgery

Conditions
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Congenital Heart Defect, Surgery-Induced Tissue Adhesions, Hemorrhage

Intervention / Treatment
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* Device: CoSeal Surgical Spray Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No CoSeal Surgical Spray<br>A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure. | |
| Experimental: CoSeal Spray Group<br>CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group. | Device: CoSeal Surgical Spray Group<br>* A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure. The dose regimen is as follows: Patients weighing < 3kg will receive 1ml of CoSeal Patients weighing 3-10kg will receive 1-2ml of CoSeal Patients weighing >10kg will receive 2-4ml of CoSeal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Adhesions at the Retrosternal Site | Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites). | Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery | 
| Severity of Adhesions at the Arterial Base Site. | Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites). | Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery | 
| Severity of Adhesions at the Diaphragm Site | Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites). | Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery | 
| Severity of Adhesions at the Left Lateral Site | Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites). | Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery | 
| Severity of Adhesions at the Right Lateral Site | Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites). | Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery | 
| Post-operative Bleeding | Post-operative bleeding through surgical site drainage output. | Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery | 
| Adhesion Burden | Skin to bypass time as an indicator of adhesion burden. | Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Stay | Number of days post surgery. | Length of stay after second surgery up to 1 month |