Effects of CoSeal in Reducing Perioperative Bleeding & Adhesions in Pediatric Heart Surgery
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Congenital Heart Defect
- Sponsor
- Loma Linda University
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Severity of Adhesions at the Retrosternal Site
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Nahidh Hasaniya
Associate Professor
Loma Linda University
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
Outcomes
Primary Outcomes
Severity of Adhesions at the Retrosternal Site
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 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
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 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
Time Frame: 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 Frame: 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.
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 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
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 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
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 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).
Secondary Outcomes
- Hospital Stay(Length of stay after second surgery up to 1 month)