Properties of collagen-based hemostatic patch compared to oxidized cellulose-based patch

Paul Slezak,Xavier Monforte,James Ferguson,Daniel Spazierer,Heinz Gulle,Heinz Redl,Sanja Sutalo

doi:10.1007/s10856-018-6078-9

Abstract

Two self-adhering hemostatic patches, based on either PEG-coated collagen (PCC) or PEG-coated oxidized cellulose (PCOC), are compared regarding to maximum burst pressure, mechanical stability, and swelling. In addition, the induction of tissue adhesions by the materials was assessed in a rabbit liver abrasion model. Both materials showed comparable sealing efficacy in a burst pressure test (37 ± 16 vs. 35 ± 8 mmHg, P = 0.730). After incubation in human plasma, PCC retained its mechanical properties over the test period of 8 h, while PCOC showed faster degradation after the 2 h time-point. The degradation led to a significantly decreased force at break (minimum force at break 0.55 N during 8 h for PCC, 0.27 N for PCOC; p < 0.001). Further, PCC allowed significantly higher deformation before break (52% after 4 h and 50% after 8 h for PCC, 18% after 4 h and 23% after 8 h for PCOC; p = 0.003 and p < 0.001 for 4 h and 8 h, respectively) and showed less swelling in human plasma (maximum increase in thickness: ~20% PCC, ~100% PCOC). Faster degradation of PCOC was visible macroscopically and histologically in vivo after 14 days. PCC showed visible structural residues with little cellular infiltration while strong infiltration with no remaining structural material was seen with PCOC. In vivo, a higher incidence of adhesion formation after PCOC application was detected. In conclusion, PCC has more reliable mechanical properties, reduced swelling, and less adhesion formation than PCOC. PCC may offer greater clinical benefit for surgeons in procedures that have potential risk for body fluid leakage or that require prolonged mechanical stability.

Highlights

Along with the surgical control of bleeding with sutures and electrocautery, the use of local hemostats is the current standard of care [1]
For dry PEG-coated oxidized cellulose (PCOC) the mean was significantly higher with 23.16 ± 0.47 N (p < 0.001)
Deformation of PCOC increased at 4 and 8 h but was still significantly smaller than of PEG-coated collagen (PCC) (18% after 4 h and 23% after 8 h for PCOC; 52% after 4 h and 50% after 8 h for PCC; p = 0.003 and p < 0.001 for 4 and 8 h, respectively)

Summary

Introduction

Along with the surgical control of bleeding with sutures and electrocautery, the use of local hemostats is the current standard of care [1]. There are several classes of hemostats: liquids (e.g., fibrin sealants), powders (e.g., starch particles), flowables (e.g., gelatin particles with thrombin [2]) and patches (e.g., fibrinogen and thrombin coated collagen). Later on, improved devices were coated with fibrinogen and thrombin to improve their hemostatic performance and to provide tissue sealing [6]. These hemostatic pads consisted of a sheet-like backing and a selfadhering surface. New hemostatic pads like polyethylenglycol (PEG)-coated collagen (PCC) [7, 8] and PEG-coated oxidized cellulose (PCOC) [9] have recently been developed and are used in surgical practice

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Conclusion