A Phase 2 interventional study of CoSeal Surgical Spray Group in Congenital Heart Defect, Surgery-Induced Tissue Adhesions and Hemorrhage, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2016-12-15.
Sponsored by Loma Linda University · Phase 2, Interventional, and Treatment
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.
1,007 studies on the registry are indexed under Heart Defects, Congenital; 257 are open to participants now.
This study's enrollment of 35 is below the median of 60 across 524 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
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Exclusion Criteria:
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 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: * Patients weighing \< 3kg will receive 1ml of CoSeal * Patients weighing 3-10kg will receive 1-2ml of CoSeal * Patients weighing \>10kg will receive 2-4ml of CoSeal
Severity of Adhesions at the Retrosternal Site
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).
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 the Arterial Base Site.
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).
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 the Diaphragm Site
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).
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 the Left Lateral Site
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).
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 the Right Lateral Site
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).
Time frame: Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery
Post-operative Bleeding
Post-operative bleeding through surgical site drainage output.
Time frame: Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery
Adhesion Burden
Skin to bypass time as an indicator of adhesion burden.
Time frame: Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)
Hospital Stay
Number of days post surgery.
Time frame: Length of stay after second surgery up to 1 month
| Milestone | No CoSeal Surgical Spray | CoSeal Spray Group |
|---|---|---|
| Started | 16 | 19 |
| Completed | 14 | 16 |
| Not completed | 2 | 3 |
| Withdrew: Death | 1 | 3 |
| Withdrew: Lost to follow-up | 1 | 0 |
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).
| percentage of participants | No CoSeal Surgical Spray | CoSeal Spray Group |
|---|---|---|
| no adhesions | 0 | 31.3 |
| filmy and avascular | 0 | 37.5 |
| requiring blunt dissection | 0 | 18.8 |
| requiring sharp dissection | 78.6 | 6.3 |
| requiring extensive sharp dissection | 21.4 | 6.3 |
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).
| percentage of participants | No CoSeal Surgical Spray | CoSeal Spray Group |
|---|---|---|
| no adhesions | 0 | 12.5 |
| filmy and avascular | 0 | 43.8 |
| requiring blunt dissection | 7.1 | 25.0 |
| requiring sharp dissection | 57.1 | 18.8 |
| requiring extensive sharp dissection | 35.7 | 0.0 |
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).
| percentage of participants | No CoSeal Surgical Spray | CoSeal Spray Group |
|---|---|---|
| no adhesions | 0 | 0 |
| filmy and avascular | 0 | 85.7 |
| requiring blunt dissection | 0 | 14.3 |
| requiring sharp dissection | 100 | 0 |
| requiring extensive sharp dissection | 0 | 0 |
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).
| percentage of participants | No CoSeal Surgical Spray | CoSeal Spray Group |
|---|---|---|
| no adhesions | 0 | 8.3 |
| filmy and avascular | 0 | 50.0 |
| requiring blunt dissection | 0 | 8.3 |
| requiring sharp dissection | 87.5 | 33.3 |
| requiring extensive sharp dissection | 12.5 | 0 |
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).
| percentage of participants | No CoSeal Surgical Spray | CoSeal Spray Group |
|---|---|---|
| no adhesions | 0 | 6.3 |
| filmy and avascular | 0 | 25.0 |
| requiring blunt dissection | 7.7 | 50.0 |
| requiring sharp dissection | 53.8 | 18.8 |
| requiring extensive sharp dissection | 38.5 | 0.0 |
Post-operative bleeding through surgical site drainage output.
| cm^3 | No CoSeal Surgical Spray | CoSeal Spray Group |
|---|---|---|
| Post-operative Bleeding | 106.38 ± 78.539 | 108.64 ± 116.449 |
Skin to bypass time as an indicator of adhesion burden.
| minutes | No CoSeal Surgical Spray | CoSeal Spray Group |
|---|---|---|
| Adhesion Burden | 37.39 ± 10.445 | 23.44 ± 6.366 |
Number of days post surgery.
| days | No CoSeal Surgical Spray | CoSeal Spray Group |
|---|---|---|
| Hospital Stay | 4.75 ± 2.832 | 6.29 ± 5.269 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No CoSeal Surgical Spray | — | 1/16 (6.3%) | 0/16 (0%) |
| CoSeal Spray Group | — | 3/19 (15.8%) | 0/19 (0%) |
| Event | No CoSeal Surgical Spray | CoSeal Spray Group |
|---|---|---|
| Cardiac Arrest unrelated to deviceCongenital, familial and genetic disorders | 1/16 | 3/19 |
| Age, Categorical(Participants) | No CoSeal Surgical Spray | CoSeal Spray Group | Total |
|---|---|---|---|
| <=18 years | 16 | 19 | 35 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | No CoSeal Surgical Spray | CoSeal Spray Group | Total |
|---|---|---|---|
| Mean | 1 (0 to 2) | 1 (0 to 2) | 1 (0 to 2) |
| Gender(Participants) | No CoSeal Surgical Spray | CoSeal Spray Group | Total |
|---|---|---|---|
| Female | 2 | 7 | 9 |
| Male | 14 | 12 | 26 |
| Region of Enrollment(participants) | No CoSeal Surgical Spray | CoSeal Spray Group | Total |
|---|---|---|---|
| United States | 16 | 19 | 35 |
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