This prospective single-arm pilot study will evaluate the application of meshed 5 × 7 cm Restrata® sheets to the abdominal wall donor site following deep inferior epigastric perforator (DIEP) or abdominal wall autologous free tissue transfer in 20 eligible patients.
Scheduled for DIEP or abdominal wall autologous free tissue transfer procedure.
At least 18 years of age.
Karnofsky performance status ≤ 80%
Ability to understand and willingness to sign an IRB approved written informed consent document.
Current smoker.
Body mass index > 39.9.
Received systemic chemotherapy within 4 weeks prior to the scheduled DIEP or abdominal wall autologous free tissue transfer procedure.
Uncontrolled diabetes mellitus determined by the investigator.
Single group
Restrata®
DeviceRestrata® is prepared in 5 x 7cm sheets and will be administered to the abdominal wall donor site following the flab harvest.
Rate of post-operative seroma, hematoma formation, or wound dehiscence within 6 weeks of procedure
Clinical assessment of seroma formation will be conducted by the investigator through evaluation of the surgical site for the presence of swelling and/or fluid wave upon exam. Clinical assessment of hematoma formation and wound dehiscence will be conducted by the investigator through evaluation of the surgical site for the presence of swelling, discoloration, and firmness to the touch upon palpitation. Wound dehiscence is defined as separation of the margins of the closed surgical incision made in the skin, with or without exposure/protrusion of underlying tissue.
Rate of post-operative infection
Post-operative infection will be assessed via the occurrence of physiological symptoms including fever, pain, swelling, erythema, or seroma via clinical assessment. Post-operative infection will be summarized as absolute counts and as descriptive proportions along with corresponding 95% confidence intervals.
Rate of post-operative wound dehiscence within 3 months of procedure
Post-operative wound dehiscence will be determined via ultrasound and clinical assessment of the surgical site. Wound dehiscence is defined as separation of the margins of the closed surgical incision made in the skin, with or without exposure/protrusion of underlying tissue. Wound dehiscence will be summarized as absolute counts and as descriptive proportions along with corresponding 95% confidence intervals.
Rate of unplanned re-operation at the donor site
Incidence of unplanned reoperation of the donor site from the initial surgical procedure will be assessed as they occur and reported as absolute counts and descriptive proportions along with corresponding 95% confidence intervals.
Drain output in cc
Total drain output in cc will be reported as means with standard deviation if data is normally distributed and as medians with interquartile and absolute ranges if skewed.
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Washington University School of Medicine
Lead sponsor
Acera Surgical, Inc.
Collaborator
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