MastectomyNCT05975359
Assessment of the Interi Manifold in Implant-Based Breast Reconstruction
A study testing Interi Manifold Drain System and Jackson Pratt Drain System in people with Mastectomy and Implant Based Breast Reconstruction, run by Stanford University at 1 site in United States.
Trial summary
Patients with breast cancer that elect to undergo implant-based breast reconstruction (IBBR) often require the placement of a surgical drain. Surgical drains are used to manage dead space and prevent seroma formation or accumulation of fluid within the surgical field postoperatively. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Mastectomy, Implant Based Breast Reconstruction
- What is being tested?
- Interi Manifold Drain System and Jackson Pratt Drain System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2023to Jun 2027
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer diagnosis (any form) or Genetic mutation with presence of breast mass.
- Indication for bilateral mastectomy
- Plan for immediate, implant-based pre-pectoral breast reconstruction using an acellular dermal matrix
- Age 18 - 65
- Female Sex
- Ability to understand and the willingness to personally sign the written IRB-approved informed consent document (English language).
Who cannot join
- Have a prior history of radiation to the breast or planned radiotherapy to the breast within the first year post-operatively.
- Are enrolled in another study that requires the concomitant use of any investigational product during the study period that the Principal Investigator believes will interfere with study endpoints.
- Have received oncologic chemotherapy within the past 21 days or planned within the time fame of the study intervention. Have received antiplatelet therapy (other than aspirin) and/ or other anticoagulation therapy in the past 60 days.
- Are a smoker or use illicit drugs.
- Any prior allergic reaction to Teflon.
- Are pregnant or nursing.
Show all 9Show fewer
- Are undergoing a delayed reconstruction following mastectomy.
- HIV infection, active UTI infection, or other active infection.
- Those requiring more than one Manifold for fluid removal per breast will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital and Clinics
Palo Alto, California, 94304
About this study
Official title: A Pilot Study of the Interi Manifold With Traditional Surgical Drains in Implant-Based Breast Reconstruction
Patients with breast cancer that elect to undergo implant-based breast reconstruction (IBBR) often require the placement of a surgical drain. Surgical drains are used to manage dead space and prevent seroma formation or accumulation of fluid within the surgical field postoperatively. The most frequently used drain is a Jackson-Pratt (JP) drain, which is limited by poor surgical site coverage and low capacity, leading to inconsistent suction and prolonged time that a drain is left in place. The Interi Drain system is a novel, multi-branched manifold with a proprietary suction system that provides consistent suction and addresses many of the shortcoming of JP drains. The purpose of this study is to compare the Interi system to standard JP drains across outcomes including number of surgical drain sites, complication rates, time to drain removal, time to initiate tissue expansion, total fluid volume drained, and patient satisfaction.
Read the detailed description
Patients seeking a mastectomy with immediate tissue expander/implant-based breast reconstruction will be considered. Potential participants will be screened for inclusion and exclusion criteria and informed of the study protocols, risk, and potential benefits.
Consenting patients who meet eligibility criteria will undergo bilateral mastectomy and immediate, implant-based breast reconstruction using a tissue expander. On the day of surgery, patient breasts will be randomized into the Interi cohort or the JP cohort, such that in each patient one breast receives the Interi drain and the other receives JP drains. Randomization will be stratified by the laterality of the primary tumor. The respective drains will be placed intraoperatively.
Postoperative care will proceed as standard. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout recovery will also take place until removal of the drain systems, which typically occurs 1-3 weeks after surgery. While drains are in place, patients will be required to monitor drain output and keep a daily drain log. Thereafter, follow-ups will be scheduled as needed (monthly) according to the usual clinical practice of implant-based breast reconstruction. This will include routine tissue expansion in preparation for the second stage expander to definitive implant exchange.
- Conditions
- Mastectomy, Implant Based Breast Reconstruction
- Being tested
- Interi Manifold Drain System, Jackson Pratt Drain System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interi Manifold Drain SystemDevice
Also called Interi manifold; Interi drain; Interi surgical drain
The Interi manifold surgical drain system will be placed in the breast pocket during stage 1 immediate implant based breast reconstruction. Output of the interi drain will be monitored daily and the Interi drain will remain in the surgical site until criteria for drain removal are met. Removal of the Interi drain will be performed in clinic by surgical staff.
Jackson Pratt Drain SystemDevice
Also called JP drain; JP surgical drain
The Jackson Pratt surgical drain system will be placed in the breast pocket during stage 1 immediate implant based breast reconstruction. Output of the Jackson Pratt drain will be monitored daily and the drain will remain in the surgical site until criteria for drain removal are met. Removal of the Jackson Pratt drain will be performed in clinic by surgical staff.
| Study group | Role | What they receive |
|---|---|---|
| Interi Manifold Drain System | Experimental | Following bilateral mastectomy, stage 1 surgery for immediate implant-based breast reconstruction will be performed in each patient breast. The breast randomized to treatment with the Interi manifold (intervention arm) will have the Interi manifold placed alongside the tissue expander intra-operatively. Surgical reconstruction, closure, and post-operative management will proceed as standard. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout recovery will also take place until removal of the Interi drain system, which typically occurs 1-3 weeks after surgery. Criteria for drain removal is defined as 2 consecutive days with drain output below 30 mL. While drains are in place, patients will be required to monitor drain output and keep a daily drain log. Receives: Device: Interi Manifold Drain System |
| Jackson Pratt Drain System | Active comparator | Following bilateral mastectomy, stage 1 surgery for immediate implant-based breast reconstruction will be performed in each patient breast. The breast randomized to treatment with the Jackson Pratt drain (active comparator arm) will have the Jackson Pratt drain placed alongside the tissue expander intra-operatively. Surgical reconstruction, closure, and post-operative management will proceed as standard. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout recovery will also take place until removal of the Jackson Pratt drain system, which typically occurs 1-3 weeks after surgery. Criteria for drain removal is defined as 2 consecutive days with drain output below 30 mL. While drains are in place, patients will be required to monitor drain output and keep a daily drain log. Receives: Device: Jackson Pratt Drain System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device safety
Incidence of adverse events or complications (e.g. seroma, hematoma, infection, dehiscence, etc.) will be recorded for both drain systems.
Measured: Complications will be recorded until stage 2 surgery (replacement of tissue expanders with permanent implants), which typically occurs after 6 months.
Time to drain removal
The number of days between placement of each drain system (stage 1 surgery) and removal of the drain (defined as 2 consecutive days with drain output below 30 mL).
Measured: Drain removal typically occurs between 1-3 weeks post-op.
Secondary outcomes (5)
Number of drain sites
The number of drain sites (holes exiting the surgical site) in each breast.
Measured: This will be recorded by the surgeon immediately after completion of the stage 1 operation.
Total fluid drained
The amount of fluid (mL) collected by each surgical drain from the operative breast for the duration of drain placement will be recorded for both drain systems.
Measured: Drain removal typically occurs between 1-3 weeks post-op.
Time to initiate tissue expansion
The amount of time in days after tissue expander placement (same operative time point as drain placement) for a patient to begin tissue expansion (when determined clinically appropriate by the attending physician).
Measured: Tissue expansion typically begins 3-6 weeks after stage 1 surgery.
Patient satisfaction (BreastQ)
Both quality of life and patient satisfaction will be assessed by validated patient survey (BreastQ). Each breast will be assessed independently by the patient to determine if the type of drain has affected the patient's perception of their recovery.
Measured: Administration of BreastQ will occur at specific post-operative time points (e.g. 1 week, 3 weeks, 6 months, and 1 year).
Patient satisfaction (study-specific survey)
Patient satisfaction with each drain system and ease of use will be assessed using a study-specific survey.
Measured: Administration of the study specific survey will occur at specific post-operative time points (e.g. 1 week, 2 weeks, and at drain removal).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start5 Sep 2023
- Primary completion11 Jun 2026
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies 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
- Parallel groups
- Model description
- Patients undergoing bilateral mastectomy will be eligible for this study. Each patient will receive both the Interi manifold (intervention arm) and the JP drain (comparison arm) placed in different breasts. Drain placement will be simultaneous. The laterality of different drain systems (intervention and comparison study arms) will be randomly assigned for each patient.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- IC Surgical, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975359
- Sponsor's protocol ID
- IRB-69609
- Other IDs
- NCI-2024-02053
- Status last verified
- Sep 2026
- First submitted
- 27 Jul 2023
- Last updated
- 2 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Interi Manifold With Traditional Surgical Drains in Implant-Based Breast Reconstruction
- ClinicalTrials.gov ID
- NCT05975359
- Acronym / sponsor ID
- IRB-69609
- Conditions
- Mastectomy, Implant Based Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- IC Surgical, Inc.
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Aug 2023 (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.
Patients with breast cancer that elect to undergo implant-based breast reconstruction (IBBR) often require the placement of a surgical drain. Surgical drains are used to manage dead space and prevent seroma formation or accumulation of fluid within the surgical field postoperatively. The most frequently used drain is a Jackson-Pratt (JP) drain, which is limited by poor surgical site coverage and low capacity, leading to inconsistent suction and prolonged time that a drain is left in place. The Interi Drain system is a novel, multi-branched manifold with a proprietary suction system that provides consistent suction and addresses many of the shortcoming of JP drains. The purpose of this study is to compare the Interi system to standard JP drains across outcomes including number of surgical drain sites, complication rates, time to drain removal, time to initiate tissue expansion, total fluid volume drained, and patient satisfaction.
Detailed description
Patients seeking a mastectomy with immediate tissue expander/implant-based breast reconstruction will be considered. Potential participants will be screened for inclusion and exclusion criteria and informed of the study protocols, risk, and potential benefits.
Consenting patients who meet eligibility criteria will undergo bilateral mastectomy and immediate, implant-based breast reconstruction using a tissue expander. On the day of surgery, patient breasts will be randomized into the Interi cohort or the JP cohort, such that in each patient one breast receives the Interi drain and the other receives JP drains. Randomization will be stratified by the laterality of the primary tumor. The respective drains will be placed intraoperatively.
Postoperative care will proceed as standard. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout recovery will also take place until removal of the drain systems, which typically occurs 1-3 weeks after surgery. While drains are in place, patients will be required to monitor drain output and keep a daily drain log. Thereafter, follow-ups will be scheduled as needed (monthly) according to the usual clinical practice of implant-based breast reconstruction. This will include routine tissue expansion in preparation for the second stage expander to definitive implant exchange.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients undergoing bilateral mastectomy will be eligible for this study. Each patient will receive both the Interi manifold (intervention arm) and the JP drain (comparison arm) placed in different breasts. Drain placement will be simultaneous. The laterality of different drain systems (intervention and comparison study arms) will be randomly assigned for each patient.
| Arm | Type | Receives |
|---|---|---|
| Interi Manifold Drain System | Experimental | Device: Interi Manifold Drain SystemFollowing bilateral mastectomy, stage 1 surgery for immediate implant-based breast reconstruction will be performed in each patient breast. The breast randomized to treatment with the Interi manifold (intervention arm) will have the Interi manifold placed alongside the tissue expander intra-operatively. Surgical reconstruction, closure, and post-operative management will proceed as standard. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout recovery will also take place until removal of the Interi drain system, which typically occurs 1-3 weeks after surgery. Criteria for drain removal is defined as 2 consecutive days with drain output below 30 mL. While drains are in place, patients will be required to monitor drain output and keep a daily drain log. |
| Jackson Pratt Drain System | Active comparator | Device: Jackson Pratt Drain SystemFollowing bilateral mastectomy, stage 1 surgery for immediate implant-based breast reconstruction will be performed in each patient breast. The breast randomized to treatment with the Jackson Pratt drain (active comparator arm) will have the Jackson Pratt drain placed alongside the tissue expander intra-operatively. Surgical reconstruction, closure, and post-operative management will proceed as standard. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout recovery will also take place until removal of the Jackson Pratt drain system, which typically occurs 1-3 weeks after surgery. Criteria for drain removal is defined as 2 consecutive days with drain output below 30 mL. While drains are in place, patients will be required to monitor drain output and keep a daily drain log. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Breast cancer diagnosis (any form) or Genetic mutation with presence of breast mass.
- Indication for bilateral mastectomy
- Plan for immediate, implant-based pre-pectoral breast reconstruction using an acellular dermal matrix
- Age 18 - 65
- Female Sex
Key exclusion criteria (9 listed)
- Have a prior history of radiation to the breast or planned radiotherapy to the breast within the first year post-operatively.
- Are enrolled in another study that requires the concomitant use of any investigational product during the study period that the Principal Investigator believes will interfere with study endpoints.
- Have received oncologic chemotherapy within the past 21 days or planned within the time fame of the study intervention. Have received antiplatelet therapy (other than aspirin) and/ or other anticoagulation therapy in the past 60 days.
- Are a smoker or use illicit drugs.
- Any prior allergic reaction to Teflon.
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 |
|---|---|---|
| Interi Manifold Drain SystemAlso: Interi manifold; Interi drain; Interi surgical drainThe Interi manifold surgical drain system will be placed in the breast pocket during stage 1 immediate implant based breast reconstruction. Output of the interi drain will be monitored daily and the Interi drain will remain in the surgical site until criteria for drain removal are met. Removal of the Interi drain will be performed in clinic by surgical staff. | Device | Interi Manifold Drain System |
| Jackson Pratt Drain SystemAlso: JP drain; JP surgical drainThe Jackson Pratt surgical drain system will be placed in the breast pocket during stage 1 immediate implant based breast reconstruction. Output of the Jackson Pratt drain will be monitored daily and the drain will remain in the surgical site until criteria for drain removal are met. Removal of the Jackson Pratt drain will be performed in clinic by surgical staff. | Device | Jackson Pratt Drain System |
Primary outcome
Device safety
Time frame: Complications will be recorded until stage 2 surgery (replacement of tissue expanders with permanent implants), which typically occurs after 6 months.
Incidence of adverse events or complications (e.g. seroma, hematoma, infection, dehiscence, etc.) will be recorded for both drain systems.
Time to drain removal
Time frame: Drain removal typically occurs between 1-3 weeks post-op.
The number of days between placement of each drain system (stage 1 surgery) and removal of the drain (defined as 2 consecutive days with drain output below 30 mL).
5 secondary outcomes
Number of drain sites
Time frame: This will be recorded by the surgeon immediately after completion of the stage 1 operation.
Total fluid drained
Time frame: Drain removal typically occurs between 1-3 weeks post-op.
Time to initiate tissue expansion
Time frame: Tissue expansion typically begins 3-6 weeks after stage 1 surgery.
Patient satisfaction (BreastQ)
Time frame: Administration of BreastQ will occur at specific post-operative time points (e.g. 1 week, 3 weeks, 6 months, and 1 year).
Patient satisfaction (study-specific survey)
Time frame: Administration of the study specific survey will occur at specific post-operative time points (e.g. 1 week, 2 weeks, and at drain removal).
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 2 Oct 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interi Manifold Drain System and Jackson Pratt Drain System in people with Mastectomy and Implant Based 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 6 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: under way, not looking for participants, as of the sponsor's last update on 2 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?
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?
Device safety (time frame: Complications will be recorded until stage 2 surgery (replacement of tissue expanders with permanent implants), which typically occurs after 6 months.). The study lists 2 primary outcomes in all. 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 2 Oct 2026.