Evaluation of a Novel Bioscaffold Implant System to Prevent Surgical Site Complications and Infections

Background: Effective post-operative management of dead space and the prevention of surgical complications can be difficult to achieve. The progression of complications resulting from ineffective apposition of healing tissue surfaces can lead to outcomes spanning from poor post-surgery cosmesis through to severe surgical site infections and wound dehiscence. Furthermore, the prolonged presence of serous fluids can attribute to flap-graft necrosis and complications in the localized drug treatment of diseases such as cancer.

Purpose: While many different techniques and devices have been trialed a simple, effective and universal means to manage clinical dead space is yet to be clinically established.

Methods: A proof-of-concept evaluation was performed using an ovine latissimus dorsi seroma model to compare treatment outcomes of a new novel bioscaffold implant system to a non-treatment control group. The novel bioscaffold implant system comprised of a hybrid ovine extracellular matrix† and bioresorbable polymer implantable device which was in fluid connection to an externally mounted portable electronic source of negative pressure via a connected tube.

An ultrasound evaluation of the surgical site was performed seven (t=7) days post-surgery with a post-mortem gross assessment performed fourteen (t=14) days post-surgery.

Results: Significant improvements in tissue integration and apposition were observed for the treatment group during the gross visual assessment time point, with the ultrasound assessment also confirming a significant reduction in fluid retention and fibrin formation.

There were also no complications observed in association with the use of the implant device.

Conclusions: It was therefore concluded that the bioscaffold implant system could provide an effective means to eliminate dead space and prevent complications at the surgical site.