Case Series/Study

(CS-012) Bilayer biodegradable synthetic matrix used for limb salvage in patients with complex wounds.

Co-Author(s):

Javier Guirola, MD – Senior Medical Science Liaison, Clinical, Polynovo

Introduction: <span style="font-size: 11.0pt; line-height: 107%; font-family: 'Calibri',sans-serif; mso-ascii-theme-font: minor-latin; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;"><span style="font-size: 11.0pt; line-height: 107%; font-family: 'Calibri',sans-serif; mso-ascii-theme-font: minor-latin; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">Below-knee amputations are known to increase mortality rates in patients with vascular insufficiency. The desired outcomes of limb salvage are to preserve the limbs and their functionality. , bilayer biodegradable synthetic matrix (BBSM) has been created to treat patients with complex wounds that would often result in lower limb amputation by functioning as a temporizing matrix. Its unique microarchitecture promotes new organized tissue formation while its sealing membrane temporizes the wound. The goal of this study was to evaluate the efficacy of BBSM as a treatment option in complicated limb salvage cases by promoting healthy tissue formation and wound closure. Methods: <span style="font-size: 11.0pt; line-height: 107%; font-family: 'Calibri',sans-serif; mso-ascii-theme-font: minor-latin; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">This is a retrospective case review, that includes two patients with different complex wound etiologies, who were in need of a limb salvage treatment option and treated with BBSM. Patient A: 30-year-old patient with Lupus associated lower limb ischemia and Factor V Leiden deficiency which lead to a dysvascular limb requiring revascular procedure and open midfoot amputation which lead to chronic wound. BBSM was applied and monitored. Dressing changes were performed daily. Patient B: 59-year-old patient with wet gangrenous forefoot with PAD and bilateral foot amputation with exposed deep anatomic structures. BBSM was applied and dressing changes were performed daily. Results: Patient A’s BBSM was delaminated after 3 weeks revealing a healthy granular base of tissue. Wound was subsequently treated with NPWT to allow for secondary intention healing. Due to the progress and patients improvement the decision was made to allow the area to continue to heal by secondary intention without the need for STSG. Wound closed at 6 months and has remained closed for 18 months. 
Patient B’s BBSM began to auto-delaminate revealing organized tissue over deep exposed structures that went on to achieve complete epithelization at week 12. The patient's limb's functionality returned, restoring the patient's activity and ambulation. Discussion: <span style="font-size: 11.0pt; line-height: 107%; font-family: 'Calibri',sans-serif; mso-ascii-theme-font: minor-latin; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">While initially designed to provide a temporizing membrane for preparation of the wound for split thickness grafting. Presented were two cases where BBSM provided a scaffold for complete wound healing by secondary intention. BBSM has demonstrated to be an effective treatment option in two limb salvage cases by promoting healthy organized tissue formation in complex wounds that may prevent the need for limb loss or need for further surgical intervention in these two cases. Further level 1 studies will need to be performed to confirm these findings, also long term follow ups will be required to asses the preserved limbs. Trademarked Items: References: