Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

Phase 2

Completed

Conditions: Surgery-Induced Tissue Adhesions
Hemorrhage
Congenital Heart Defect

Interventions: Device: CoSeal Surgical Spray Group

Registration Number: NCT01330433

Lead Sponsor: Loma Linda University

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CoSeal Spray Group	CoSeal Surgical Spray Group	CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.

Primary Outcome Measures

Name	Time	Method
Severity of Adhesions at the Retrosternal Site	Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery	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 at the Diaphragm Site	Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery	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).
Post-operative Bleeding	Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery	Post-operative bleeding through surgical site drainage output.
Adhesion Burden	Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)	Skin to bypass time as an indicator of adhesion burden.
Severity of Adhesions at the Arterial Base Site.	Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery	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 at the Left Lateral Site	Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery	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 at the Right Lateral Site	Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery	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).