Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction

• Restrata® (Device), also known as Synthetic Electrospun Fiber Matrix, SEFM: Restrata® is prepared in 5 x 7cm sheets and will be administered to the abdominal wall donor site following the flab harvest.

Primary outcomes

• Rate of post-operative seroma, hematoma formation, or wound dehiscence within 6 weeks of procedure [At time of procedure to 6 weeks after procedure (total estimated time: 6 weeks)]: 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.

Secondary outcomes

• Rate of post-operative infection [At time of procedure until 3 months after procedure (total estimated time: 3 months)]: 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 [At time of procedure until 3 months after procedure (total estimated time: 3 months)]: 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 [At time of procedure until 3 months after procedure (total estimated time: 3 months)]: 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 [At time of drain removal (total estimated time: 1-4 weeks)]: 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.
• Time of transfer procedure to drain removal as assessed in days [At time of procedure until time of drain removal (total estimated time 1-4 weeks)]: Drains will be removed when output is less than 30 cc over 24 hours. Time of transfer procedure to drain removal in days will be reported as means with standard deviation if data is normally distributed and as medians with interquartile and absolute ranges if skewed.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

  *Note: if there is documentation of HgbA1c > 12% within 3 months of the scheduled DIEP or abdominal wall autologous free tissue transfer procedure, it will need to be reviewed by the PI to determine the patient's clinical situation and eligibility.
* Pregnant.
* Currently receiving any investigational agents.
* Known sensitivity to resorbable sutures (polyglactin 910, polydioxanone).

• Justin Sacks, MD, MBA, FACS, Principal investigator, Washington University School of Medicine