Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery

Loma Linda University (LLU)

Status and phase: Completed; Phase 2

Conditions: Hemorrhage; Congenital Heart Defect; Surgery-Induced Tissue Adhesions

Treatments: Device: CoSeal Surgical Spray Group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01330433

5110074

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

No CoSeal Surgical Spray

No Intervention group

Description:

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.

CoSeal Spray Group

Experimental group

Description:

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

Treatment:

Device: CoSeal Surgical Spray Group