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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
35
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
Loma Linda University Medical Center
Loma Linda, California, United States
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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 frame: Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)
Hospital Stay
Number of days post surgery.
Time frame: Length of stay after second surgery up to 1 month
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