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

A Prospective Pilot Study of Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Reconstruction; Breast Reconstruction After Mastectomy; Deep Inferior Epigastric Perforator
• Intervention / Treatment: Device: Restrata®

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justin Sacks, MD, MBA, FACS; Phone Number: 314-454-4894; Email: jmsacks@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
      • Contact: Justin Sacks, MD, MBA, FACS; Phone Number: 314-454-4894; Email: jmsacks@wustl.edu
      • Principal Investigator: Justin Sacks, MD, MBA, FACS
      • Sub-Investigator: William Zhu, MD
      • Sub-Investigator: Terence Myckatyn, MD
      • Sub-Investigator: Gary Skolnick, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Restrata® application; Patients undergoing standard of care deep inferior epigastric perforator (DIEP) or abdominal wall free tissue transfer procedure will have Restrata® sheets applied to the abdominal wall donor site following flap harvest. Patients will be followed for 12 months to assess outcomes.	Device: Restrata®; Restrata® is prepared in 5 x 7cm sheets and will be administered to the abdominal wall donor site following the flab harvest.; Other Names: Synthetic Electrospun Fiber Matrix; SEFM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At time of procedure to 6 weeks after procedure (total estimated time: 6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At time of procedure until 3 months after procedure (total estimated time: 3 months)
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.	At time of procedure until 3 months after procedure (total estimated time: 3 months)
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.	At time of procedure until 3 months after procedure (total estimated time: 3 months)
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.	At time of drain removal (total estimated time: 1-4 weeks)
Time of transfer procedure to drain removal as assessed in days	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.	At time of procedure until time of drain removal (total estimated time 1-4 weeks)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Acera Surgical, Inc.
• Investigators: Principal Investigator: Justin Sacks, MD, MBA, FACS, Washington University School of Medicine

Publications and helpful links

Helpful Links

• <p>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</p>

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): January 11, 2028
• Study Completion (Estimated): February 29, 2028

Study Registration Dates

• First Submitted: September 24, 2026
• First Submitted That Met QC Criteria: September 24, 2026
• First Posted (Actual): October 1, 2026

Study Record Updates

• Last Update Posted (Actual): October 1, 2026
• Last Update Submitted That Met QC Criteria: September 24, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Breast reconstruction; Microvascular; DIEP (Deep Inferior Epigastric Perforators)
• Other Study ID Numbers: 26-X358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes