Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery
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.
Congenital Heart Defect
Surgery-Induced Tissue Adhesions
Device: CoSeal Surgical Spray Group
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effects of CoSeal in Reducing Perioperative Bleeding & Adhesions in Pediatric Heart Surgery|
- Severity of adhesions at seven predefined sites [ Time Frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery ] [ Designated as safety issue: No ]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).
- Post-operative bleeding [ Time Frame: Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]Skin to bypass time as an indicator of adhesion burden.
- Ease of use [ Time Frame: Data on use of CoSeal will be collected immediately following the surgery (on average 0-60 minutes postoperatively) ] [ Designated as safety issue: No ]Ease of use of CoSeal - graded by primary surgeon using a Likert-scale (ranging from 1 [very easy] to 5 [very difficult]).
- Type and duration of surgery [ Time Frame: Type and duration of surgery is noted during the first 24 hours postoperatively ] [ Designated as safety issue: No ]Type and duration of operation and reoperation
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
No Intervention: No CoSeal Surgical Spray
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
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
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:
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330433
|Contact: Megan Russell, MAfirstname.lastname@example.org|
|Contact: Nahidh Hasaniya, MDemail@example.com|
|United States, California|
|Loma Linda University Medical Center||Recruiting|
|Loma Linda, California, United States, 92602|
|Contact: Megan ET Russell, MA 909-558-4354 firstname.lastname@example.org|
|Contact: Nahidh Hasaniya, MD 909-558-4354 email@example.com|
|Principal Investigator: Nahidh Hasaniya, MD, PhD|
|Sub-Investigator: Leonard L Bailey, MD|
|Sub-Investigator: Anees Razzouk, MD|
|Sub-Investigator: Alfredo Rasi, MD|
|Sub-Investigator: Aziz Ghaly, MD|
|Sub-Investigator: Rosario Floridia, MD|
|Principal Investigator:||Nahidh Hasaniya, MD||Loma Linda University Medical Center|
|Study Chair:||Anees Razzouk, MD||Loma Linda University Medical Center|