Breast ReconstructionNCT07851415
Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction
A study testing Restrata® in people with Breast Reconstruction and Deep Inferior Epigastric Perforator, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Reconstruction, Deep Inferior Epigastric Perforator, Breast Reconstruction After Mastectomy
- What is being tested?
- Restrata®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 29 Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
Justin Sacks, MD, MBA, FACS, 314-454-4894, jmsacks@wustl.edu
Justin Sacks, MD, MBA, FACS
About this study
Official title: 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.
- Conditions
- Breast Reconstruction, Deep Inferior Epigastric Perforator, Breast Reconstruction After Mastectomy
- Being tested
- Restrata®
- Keywords
- Breast reconstruction, DIEP (Deep Inferior Epigastric Perforators), Microvascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrata®Device
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Restrata® application | Experimental | 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. Receives: Device: Restrata® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of procedure to 6 weeks after procedure (total estimated time: 6 weeks)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At time of procedure until time of drain removal (total estimated time 1-4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion11 Jan 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Acera Surgical, Inc.
- Responsible party
- Sponsor
- Investigators
- Justin Sacks, MD, MBA, FACS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851415
- Sponsor's protocol ID
- 26-X358
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No