Research Project
2643509
Our objective is to develop an albumin solder as a complete or partial substitute for sutures or staples during surgery. The solder is applied on the wound and welding is achieved by laser irradiation. The welding requires heat that may cause tissue necrosis. The investigators propose to produce a "low temperature" solder by removing heat stabilizers from albumin. To obtain a product suitable for clinical use, they plan to introduce an additional viral inactivation step based on UVC irradiation, to explore chromatographic techniques appropriate for the removal of heat stabilizers (to reduce denaturation temperature), and to explore a suitable bacterial sterilization technique based on either gamma irradiation or sterile filtration. The methods of evaluation of the solder quality and performance include: (i) quantitative determination of heat stabilizers, (ii) determination of denaturation temperature, (iii) in vitro determination of bonding strength using hairless guinea pig skin, (iv) monitoring wound healing in vivo in a dermal incision model in hairless guinea pigs, and (v) effect on cell cultures relevant to wound healing. The significance of an albumin solder for wound closure stems from limitations of the conventional techniques, such as stapling and suturing, which in certain surgical procedures are difficult and time consuming and may leak or bleed at the suture line. PROPOSED COMMERCIAL APPLICATION: "Low temperature" albumin solder will provide a replacement for sutures and staples. The clinical applications range from micro- to macro- surgery. The albumin solder proposed here will be particularly useful in minimally invasive surgery when sutures and staples are either inappropriate, cumbersome, or time consuming. Albumin solder has a market potential of at least $100 million.
