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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study of Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction
- ClinicalTrials.gov ID
- NCT07851415
- Acronym / sponsor ID
- 26-X358
- Conditions
- Breast Reconstruction, Deep Inferior Epigastric Perforator, Breast Reconstruction After Mastectomy
- Keywords
- Breast reconstruction, DIEP (Deep Inferior Epigastric Perforators), Microvascular
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Acera Surgical, Inc.
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 11 Jan 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restrata® application | Experimental | Device: Restrata®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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restrata®Also: Synthetic Electrospun Fiber Matrix, SEFMRestrata® is prepared in 5 x 7cm sheets and will be administered to the abdominal wall donor site following the flab harvest. | Device | Restrata® application |
Primary outcome
Rate of post-operative seroma, hematoma formation, or wound dehiscence within 6 weeks of procedure
Time frame: 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.
5 secondary outcomes
Rate of post-operative infection
Time frame: 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
Time frame: At time of procedure until 3 months after procedure (total estimated time: 3 months)
Rate of unplanned re-operation at the donor site
Time frame: At time of procedure until 3 months after procedure (total estimated time: 3 months)
Drain output in cc
Time frame: At time of drain removal (total estimated time: 1-4 weeks)
Time of transfer procedure to drain removal as assessed in days
Time frame: At time of procedure until time of drain removal (total estimated time 1-4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin Sacks, MD, MBA, FACS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin Sacks, MD, MBA, FACS (314-454-4894, jmsacks@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of post-operative seroma, hematoma formation, or wound dehiscence within 6 weeks of procedure (time frame: At time of procedure to 6 weeks after procedure (total estimated time: 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.