A gelatin-thrombin matrix for hemostasis after endoscopic sinus surgery

Area of Science:

• Otolaryngology
• Surgical Innovation
• Biomaterials

Background:

• Achieving adequate hemostasis is critical following endoscopic sinus surgery.
• Bleeding can complicate patient recovery and surgical outcomes.
• Effective hemostatic agents are essential in sinonasal procedures.

Purpose of the Study:

• To evaluate the clinical performance of Surgiflo hemostatic matrix combined with Thrombin-JMI.
• To assess the efficacy of this combination in achieving hemostasis during endoscopic sinus surgery.
• To determine patient satisfaction and evaluate postoperative healing.

Main Methods:

• A multicenter, prospective, single-arm study was conducted.
• The study included patients undergoing elective primary or revision endoscopic sinus surgery for chronic sinusitis.
• Hemostasis within 10 minutes of product application was the primary endpoint.

Main Results:

• Hemostasis was achieved within 10 minutes in 96.7% of the 30 enrolled patients (54 operated sides).
• The median time to hemostasis, including manual compression, was 61 seconds.
• No adverse events such as synechiae, adhesion, or infection were reported.

Conclusions:

• Surgiflo hemostatic matrix with Thrombin-JMI proved clinically effective for controlling surgical bleeding.
• The hemostatic matrix demonstrated a high success rate in achieving hemostasis.
• Further investigation through randomized controlled trials is recommended.