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Published on: June 14, 2015
An Absorbable Hydrogel Spray Reduces Postoperative Mediastinal Adhesions After Congenital Heart Surgery
Nahidh Hasaniya1, Anees Razzouk1, Jennifer Newcombe1
1Department of Cardiovascular and Thoracic Surgery, Loma Linda University Children's Hospital, Loma Linda, California.
Insights
A synthetic bioabsorbable polymer spray significantly reduced mediastinal adhesions and shortened reoperation time in infants undergoing repeat cardiac surgery. This innovative anti-adhesion treatment improves outcomes for pediatric cardiac reoperations.
Area of Science:
- Biomaterials Science
- Pediatric Cardiac Surgery
- Surgical Innovation
Background:
- Post-surgical adhesions complicate reoperative cardiac surgery, increasing operative time and risks.
- Mediastinal adhesions are a significant concern in pediatric cardiac reoperations.
- Effective anti-adhesion strategies are crucial for improving patient outcomes.
Purpose of the Study:
- To evaluate the efficacy of a synthetic bioabsorbable polymer spray in preventing adhesions during infant cardiac reoperations.
- To assess the impact of the polymer spray on operative time and adhesion severity.
- To investigate the anti-adhesion properties of a novel biomaterial in a pediatric surgical context.
Main Methods:
- Prospective, randomized, double-blinded clinical study involving 40 infants undergoing staged cardiac operations.
- Application of synthetic bioabsorbable polymer spray to mediastinal surfaces before chest closure in the study group.
- Adhesion evaluation using a 5-grade scoring system and measurement of incision-to-extracorporeal circulation time at reoperation.
Main Results:
- The study group (n=17) demonstrated significantly shorter incision-to-extracorporeal circulation times (23 ± 6 min) compared to the control group (n=16; 38 ± 10 min; p < 0.001).
- Significantly fewer and less severe mediastinal adhesions were observed in the polymer spray group across all five evaluated areas (p < 0.001 to p < 0.05).
- The polymer spray was well-tolerated, with no adverse events reported related to its application.
Conclusions:
- Synthetic bioabsorbable polymer sealant spray effectively reduces mediastinal adhesions after primary pediatric cardiac surgery.
- The use of this spray leads to decreased reentry time in infants requiring repeat median sternotomy.
- This biomaterial represents a promising adjunct for improving safety and efficiency in pediatric cardiac reoperations.
Background:
Adhesions encountered during reoperative cardiac surgery can prolong operative time and increase operative risk. The purpose of this clinical study was to investigate the antiadhesion property of a synthetic bioabsorbable polymer spray after cardiac reoperations in infants.
Methods:
A prospective randomized double-blinded study was designed. Forty infants requiring staged cardiac operations were randomly allocated to a study group (n = 20) or a control group (n = 20). The appropriate volume of the polymer was sprayed onto the mediastinal surfaces before chest closure after the first surgical procedure in the study group. At reoperation, adhesions were evaluated by a blinded investigator following a 5-grade scoring system. Five predetermined anatomic areas were scored. Incision to extracorporeal circulation time was also analyzed.
Results:
In all, 40 subjects were enrolled into the study. Four babies died before the second operation. Three others were missed for reevaluation. The control group (n = 16) had longer incision to extracorporeal circulation time (38 ± 10 minutes) than the study group (n = 17; 23 ± 6 minutes; p < 0.001). The control subjects had significantly more severe adhesions than the study group at all five mediastinal areas: (1) retrosternal (p < 0.001); (2) base of the heart (large vessels [p < 0.05]); (3) right side (p < 0.01); (4) left side (p < 0.02); and (5) diaphragmatic side of the mediastinum (p < 0.001).
Conclusions:
The use of synthetic bioabsorbable polymer sealant spray at the end of primary pediatric cardiac surgery reduces the intensity of mediastinal adhesions and the reentry time in infants undergoing repeat median sternotomy.
