CicatrixNCT05377723
Abdominal Scar Improvement in Microsurgical Breast Reconstruction
A study testing Neodyne Device in people with Cicatrix and Breast Reconstruction, run by Stanford University at 1 site in United States.
Trial summary
Microsurgical breast reconstruction is most commonly performed with free abdominal flaps, which leave a long transverse lower abdominal scar. Due to tension across the incision, these scars frequently widen and hypertrophy. Hence, modalities that can reduce this tendency, thus, improving scar appearance are desirable. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Cicatrix, Breast Reconstruction
- What is being tested?
- Neodyne Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2022to 17 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female Subjects who have undergone unilateral/bilateral microsurgical breast reconstruction with free abdominal flaps within approximately 1 week (4-8 days) prior to study participation.
- Appearance of subject's incision is aesthetically similar across length of incision
- Age >18
- Subject has the ability to read and comprehend as required by the protocol and the informed consent.
- Subject must be able to provide written informed consent prior to participation in the study.
Who cannot join
- Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus.
- Subjects diagnosed with scleroderma.
- Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives.
- Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application.
- Subjects with inability to maintain adequate care of incision.
- Subjects with a weight loss of > 100 lbs within 6 months from date of surgery.
Show all 9Show fewer
- Subjects who currently smoke.
- Subjects taking steroid therapy (systemic or inhaled) within 2 months from date of study enrollment.
- Subject does not qualify for the study in the opinion of the investigators.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94305
About this study
Microsurgical breast reconstruction is most commonly performed with free abdominal flaps, which leave a long transverse lower abdominal scar. Due to tension across the incision, these scars frequently widen and hypertrophy. Hence, modalities that can reduce this tendency, thus, improving scar appearance are desirable. Here, we wish to investigate the impact of the Neodyne embrace device on postoperative abdominal scar appearance. The proposed study is novel in that it is the first RCT investigating the effect of the embrace device on scar appearance in the context of microsurgical breast reconstruction.
Read the detailed description
Adult (>18 years) women who have undergone microsurgical breast reconstruction with free abdominal flap(s) approximately 1 week (5-10 days) prior to study participation will be approached by the clinical research team during their first postoperative clinic visit; the protocol asks for the device to be applied at this point. Investigators will only invite those subjects to participate whose incisions, at the 1 week postoperative visit, appear to be uniformly aesthetically similar across the length of the incision. Informed consent for randomization and study participation will be obtained.
After eligible patients have provided informed consent, the side of the abdomen to be treated with the Neodyne Device will be randomly selected by opening a sealed randomization envelope. The selected side will be treated with the Neodyne Device through the full study. The Neodyne Device will be applied to a portion of the abdominal incision by the health care provider at 1 week (4-8 days) after the procedure. The other portion of the abdominal incision will serve as the control and will be treated per the investigator's standard of care. Subjects will return to the Investigator's office for a total of 8 weeks for application and removal of the Neodyne Dressing.
At the 8th week visit subjects and investigators will complete an evaluation of the incision/scar. Subjects will return to the Investigator's office at 12 weeks from the date of the procedure for another evaluation of the incision/scar. The primary study endpoint will be evaluated at 6 months from the date of the procedure. Subjects will also be offered the opportunity to provide additional photographic evaluations at 12 months after surgery in conjunction with a standard clinic visit.
- Conditions
- Cicatrix, Breast Reconstruction
- Being tested
- Neodyne Device
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neodyne DeviceDevice
See Arm Description: Neodyne Device
| Study group | Role | What they receive |
|---|---|---|
| Neodyne Device | Experimental | After eligible patients have provided informed consent, the side of the abdomen to be treated with the Neodyne Device will be randomly selected by opening a sealed randomization envelope. The selected side will be treated with the Neodyne Device through the full study. The Neodyne Device will be applied to a portion of the abdominal incision by the health care provider at 1 week (4-8 days) after the procedure. The other portion of the abdominal incision (Arm Title: Control) will serve as the control and will be treated per the investigator's standard of care. Subjects will return to the Investigator's office for a total of 8 weeks for application and removal of the Neodyne Dressing. Receives: Device: Neodyne Device |
| Control | Other | See above Receives: Device: Neodyne Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar Assessment
The primary endpoint is the difference between the assessments of the scar appearance for the treated as compared to the control incision sites. Incisions will be evaluated by an objective independent expert panel at six months post surgery. The panel will review close-up photographic records, taken at the 6 month study endpoint, of the control incision site and the treated incision site. The subject will complete the Scar Q questionnaire and both the investigator and the subject will complete the Patient and Observer Scar Assessment Scale (POSAS). It is expected that the scar from the incision area covered by Neodyne Dressing will be minimized when compared to the scar from the untreated incision area.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start31 Oct 2022
- Primary completion30 Jan 2026
- Study completion17 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CicatrixStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Neodyne Biosciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Arash Momeni, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377723
- Sponsor's protocol ID
- IRB-59506
- Other IDs
- NCI-2023-03670
- Status last verified
- Sep 2026
- First submitted
- 5 May 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Scar Improvement in Microsurgical Breast Reconstruction
- ClinicalTrials.gov ID
- NCT05377723
- Acronym / sponsor ID
- IRB-59506
- Conditions
- Cicatrix, Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Neodyne Biosciences, Inc.
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 17 May 2022 (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.
Microsurgical breast reconstruction is most commonly performed with free abdominal flaps, which leave a long transverse lower abdominal scar. Due to tension across the incision, these scars frequently widen and hypertrophy. Hence, modalities that can reduce this tendency, thus, improving scar appearance are desirable. Here, we wish to investigate the impact of the Neodyne embrace device on postoperative abdominal scar appearance. The proposed study is novel in that it is the first RCT investigating the effect of the embrace device on scar appearance in the context of microsurgical breast reconstruction.
Detailed description
Adult (>18 years) women who have undergone microsurgical breast reconstruction with free abdominal flap(s) approximately 1 week (5-10 days) prior to study participation will be approached by the clinical research team during their first postoperative clinic visit; the protocol asks for the device to be applied at this point. Investigators will only invite those subjects to participate whose incisions, at the 1 week postoperative visit, appear to be uniformly aesthetically similar across the length of the incision. Informed consent for randomization and study participation will be obtained.
After eligible patients have provided informed consent, the side of the abdomen to be treated with the Neodyne Device will be randomly selected by opening a sealed randomization envelope. The selected side will be treated with the Neodyne Device through the full study. The Neodyne Device will be applied to a portion of the abdominal incision by the health care provider at 1 week (4-8 days) after the procedure. The other portion of the abdominal incision will serve as the control and will be treated per the investigator's standard of care. Subjects will return to the Investigator's office for a total of 8 weeks for application and removal of the Neodyne Dressing.
At the 8th week visit subjects and investigators will complete an evaluation of the incision/scar. Subjects will return to the Investigator's office at 12 weeks from the date of the procedure for another evaluation of the incision/scar. The primary study endpoint will be evaluated at 6 months from the date of the procedure. Subjects will also be offered the opportunity to provide additional photographic evaluations at 12 months after surgery in conjunction with a standard clinic visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neodyne Device | Experimental | Device: Neodyne DeviceAfter eligible patients have provided informed consent, the side of the abdomen to be treated with the Neodyne Device will be randomly selected by opening a sealed randomization envelope. The selected side will be treated with the Neodyne Device through the full study. The Neodyne Device will be applied to a portion of the abdominal incision by the health care provider at 1 week (4-8 days) after the procedure. The other portion of the abdominal incision (Arm Title: Control) will serve as the control and will be treated per the investigator's standard of care. Subjects will return to the Investigator's office for a total of 8 weeks for application and removal of the Neodyne Dressing. |
| Control | Other | Device: Neodyne DeviceSee above |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female Subjects who have undergone unilateral/bilateral microsurgical breast reconstruction with free abdominal flaps within approximately 1 week (4-8 days) prior to study participation.
- Appearance of subject's incision is aesthetically similar across length of incision
- Age >18
- Subject has the ability to read and comprehend as required by the protocol and the informed consent.
- Subject must be able to provide written informed consent prior to participation in the study.
Key exclusion criteria (9 listed)
- Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus.
- Subjects diagnosed with scleroderma.
- Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives.
- Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application.
- Subjects with inability to maintain adequate care of incision.
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 |
|---|---|---|
| Neodyne DeviceSee Arm Description: Neodyne Device | Device | Control, Neodyne Device |
Primary outcome
Scar Assessment
Time frame: 6 months
The primary endpoint is the difference between the assessments of the scar appearance for the treated as compared to the control incision sites. Incisions will be evaluated by an objective independent expert panel at six months post surgery. The panel will review close-up photographic records, taken at the 6 month study endpoint, of the control incision site and the treated incision site. The subject will complete the Scar Q questionnaire and both the investigator and the subject will complete the Patient and Observer Scar Assessment Scale (POSAS). It is expected that the scar from the incision area covered by Neodyne Dressing will be minimized when compared to the scar from the untreated incision area.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Cicatrix
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Not yet recruiting
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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. This study is not recruiting at the moment.
Arash Momeni, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neodyne Device in people with Cicatrix and Breast Reconstruction, run by Stanford University 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 15 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar Assessment (time frame: 6 months). 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 15 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.