Congenital heart defects
Conditions
Interventions
Group 1: Coseal (Baxter)
Group 2: 4DryField PH (PlantTec Medical)
Group 3: Isotonic saline
Sponsors
Klinik für Kinderherzchirurgie und Chirurgie angeborener Herzfehler, Uniklinik RWTH Aachen
Eligibility
Sex/Gender
All
Age
No minimum to 90 Days
Inclusion criteria
Inclusion criteria: 1. Newborns and infants (within 90 days after birth) with congenital cardiac anomaly who receive a systemic-to-pulmonary shunt via sternotomy. Shunt procedure (OP1) can be performed with or without CPB and include: Blalock-Taussig shunt, central aorto-pulmonary shunt and xano-shunt (right ventricular to pulmonary artery shunt). 2. The patient’s legal representative(s) approve(s) the patient’s participation in the study by signing the informed consent. 3. Anticipation that the second sternotomy procedure (OP2: bidirectional Glenn, corrective surgery or shunt-exchange) will be performed at an age of the patient beyond 2 months and within the first year of life. 4. Anticipation that both OP1 and OP2 are performed in a study center.
Exclusion criteria
Exclusion criteria: 1. Previous sternotomy except for bilateral pulmonary artery banding procedure 2. Shock (mechanical circulatory support and/or lactate > 5 mmol/l within 48 hours before surgery) 3. Infection (CRP > 20 mg/l within 48 hours before surgery) 4. Kidney failure (serum creatinine > 1.5 mg/dl or urine output < 0.5 ml/kg/h within 48 hours before surgery) 5. Known intolerance to starchy or polyethylene glycol - containing substances 6. The patient is participating in another device or drug study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean global adhesion score in each group: The second operation (OP2: shunt take-down) is documented using an operating light camera system or similar. Subsequently, the adhesion score, which is the primary endpoint of the study, is determined in a blinded manner by independent examiners. The examiners are not given any information about the group affiliation of the recordings and indicate objectively the degree of adhesions. For this purpose, the adhesions in five given anatomical areas (retrosternal, cardiac base, right side, left side, and diaphragmatic side of the mediastinum) are determined using the adhesion tissue tenacity scale (ATTS). As not all areas are prepared routinely, only three areas are included in the primary endpoint evaluation. The local adhesion score is determined in these three anatomical areas. The three local adhesion scores are then added together to form the global adhesion score. The mean group adhesion score for the respective arm is determined at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary endpoints, the user-friendliness and quality of use of application of the medical devices will be analysed. Furthermore, the influence of adhesion prophylaxis on wound healing after OP1 and on preparation times and adhesiolysis-related injuries during OP2 will be investigated. The surgeon also gives his subjective impression of the severity of adhesions. The local adhesion values in the five anatomical areas are also evaluated as secondary endpoints. | — |
Countries
Austria, Germany, Poland
Contacts
Public ContactAndré Rüffer
Klinik für Kinderherzchirurgie und Chirurgie angeborener Herzfehler, Uniklinik RWTH Aachen
Outcome results
None listed