MammaplastyNCT06504173
Diced Cartilage in Breast Reconstruction
An observational study of Mammaplasty and Microsurgery, run by ISAR Klinikum at 2 sites in Germany.
Trial summary
Exposure of internal mammary vessels in autologous breast reconstruction often requires removal of a rib cartilage segment, which can lead to contour deformity in the craniomedial breast pole. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammaplasty, Microsurgery, Rip Reconstruction Cartilage
- What is being tested?
- diced cartilage
- Type of treatment
- Surgery or procedure
- How many people
- 173 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jan 2024to 1 Jul 2024
- Phase
- Observational
- 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 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of women who received autologous free flap breast reconstruction using internal mammary vessels as recipient vessels.
Who may be able to join
- Autologous free flap breast reconstruction using the internal mammary vessels as recipient vessels from October 2021 to June 2023
- MRI subcohort: Magnetic resonance imaging (MRI) scans performed at least 6 months postoperatively
Who cannot join
- Autologous free flap breast reconstruction using a perforator of the internal mammary vessels as recipient vessels from October 2021 to June 2023
- Autologous free flap breast reconstruction using the thoracodorsal vessels as recipient vessels from October 2021 to June 2023
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
ISAR Klinikum - Department Plastic Surgery
Munich, Bavaria, 80331
ISAR Klinikum
Munich, Bavaria, 80331
About this study
Official title: Use of Diced Cartilage for Management of Internal Mammary Vessel Exposure Sites in Autologous Breast Reconstruction
Exposure of internal mammary vessels in autologous breast reconstruction often requires removal of a rib cartilage segment, which can lead to contour deformity in the craniomedial breast pole. This study evaluated the use of diced cartilage (DC) to counteract substance loss in the microvascular anastomosis area, and investigated safety and suitability of the procedure to avoid postoperative deformities.
Read the detailed description
This retrospective, single-center cohort study included all breast reconstructions in which DC was used from October 2021 to June 2023. Reconstructions using DC were subdivided based on previous exposure to breast radiotherapy (DC vs. DCR). The control group consisted of an equal number of consecutive reconstructions performed prior to the use of DC. The effect of DC on breast contour preservation was investigated using breast magnetic resonance imaging (MRI; > 6 months post-op) and photographic documentation (6-month follow-up).
- Conditions
- Mammaplasty, Microsurgery, Rip Reconstruction Cartilage
- Being tested
- diced cartilage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diced cartilageProcedure or surgery
In reconstructions using DC management of IMVES, the surgical nurse processed the removed cartilage into DC using a dermatome blade. Cartilage pieces of approximately 0,5-1 mm were used. After microvascular anastomosis (coupler device for venous anastomosis; Synovis MCA, Birmingham AL, USA), all DC was placed back into the rib removal zone using a blunt dissector. The vessels were embedded and stabilized in cartilage paste according to the desired orientation.
| Study group | Role | What they receive |
|---|---|---|
| diced cartilage (DC) | After removing a part of the rip cartilage and microsurgery, the exposed internal mammary vessels in autologous free flap breast reconstruction was restored with diced cartilage (DC) out of the removed rip cartialge. Receives: Procedure: diced cartilage | |
| control | After removing a part of the rip cartilage and microsurgery, the exposed internal mammary vessels in autologous free flap breast reconstruction was NOT restored. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic resonance imaging (MRI) scans: soft tissue sinking of the recipient vessels area
the sinking depth of epicostal soft tissue into the space of rib segment resection on axial planes in Magnetic resonance imaging (MRI) scans performed at least 6 months postoperatively
Measured: October 2021 to June 2023
Secondary outcomes (1)
Visual contour deficit of the recipient vessels area
Postoperative photographic images were examined by two investigators (blinded to group assignments) for IMVES-associated deformities using standardized photographic images of the reconstructed breasts at the 6-month follow-up.
Measured: October 2021 to June 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammaplastyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- ISAR Klinikum
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Imaging Division, Radiologie Augsburg Friedberg / Breast Center Augsburg, Augsburg, Germany
- Responsible party
- Principal investigator, Peter Paul Pfeiler, MD, ISAR Klinikum
- Investigators
- Ulf Dornseifer, MD/PhD, Study director, Head of Department plastic and reconstructive surgery ISAR Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504173
- Sponsor's protocol ID
- DIC-RIP
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Diced Cartilage for Management of Internal Mammary Vessel Exposure Sites in Autologous Breast Reconstruction
- ClinicalTrials.gov ID
- NCT06504173
- Acronym / sponsor ID
- DIC-RIP
- Conditions
- Mammaplasty, Microsurgery, Rip Reconstruction Cartilage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- ISAR KlinikumUniversity, hospital or other
- Collaborators
- Breast Imaging Division, Radiologie Augsburg Friedberg / Breast Center Augsburg, Augsburg, Germany
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 16 Jul 2024 (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.
Exposure of internal mammary vessels in autologous breast reconstruction often requires removal of a rib cartilage segment, which can lead to contour deformity in the craniomedial breast pole. This study evaluated the use of diced cartilage (DC) to counteract substance loss in the microvascular anastomosis area, and investigated safety and suitability of the procedure to avoid postoperative deformities.
Detailed description
This retrospective, single-center cohort study included all breast reconstructions in which DC was used from October 2021 to June 2023. Reconstructions using DC were subdivided based on previous exposure to breast radiotherapy (DC vs. DCR). The control group consisted of an equal number of consecutive reconstructions performed prior to the use of DC. The effect of DC on breast contour preservation was investigated using breast magnetic resonance imaging (MRI; > 6 months post-op) and photographic documentation (6-month follow-up).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diced cartilage (DC) | – | Procedure: diced cartilageAfter removing a part of the rip cartilage and microsurgery, the exposed internal mammary vessels in autologous free flap breast reconstruction was restored with diced cartilage (DC) out of the removed rip cartialge. |
| control | – | –After removing a part of the rip cartilage and microsurgery, the exposed internal mammary vessels in autologous free flap breast reconstruction was NOT restored. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of women who received autologous free flap breast reconstruction using internal mammary vessels as recipient vessels.
Key inclusion criteria (2 listed)
- Autologous free flap breast reconstruction using the internal mammary vessels as recipient vessels from October 2021 to June 2023
- MRI subcohort: Magnetic resonance imaging (MRI) scans performed at least 6 months postoperatively
Key exclusion criteria (2 listed)
- Autologous free flap breast reconstruction using a perforator of the internal mammary vessels as recipient vessels from October 2021 to June 2023
- Autologous free flap breast reconstruction using the thoracodorsal vessels as recipient vessels from October 2021 to June 2023
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 |
|---|---|---|
| diced cartilageIn reconstructions using DC management of IMVES, the surgical nurse processed the removed cartilage into DC using a dermatome blade. Cartilage pieces of approximately 0,5-1 mm were used. After microvascular anastomosis (coupler device for venous anastomosis; Synovis MCA, Birmingham AL, USA), all DC was placed back into the rib removal zone using a blunt dissector. The vessels were embedded and stabilized in cartilage paste according to the desired orientation. | Procedure or surgery | diced cartilage (DC) |
Primary outcome
Magnetic resonance imaging (MRI) scans: soft tissue sinking of the recipient vessels area
Time frame: October 2021 to June 2023
the sinking depth of epicostal soft tissue into the space of rib segment resection on axial planes in Magnetic resonance imaging (MRI) scans performed at least 6 months postoperatively
1 secondary outcome
Visual contour deficit of the recipient vessels area
Time frame: October 2021 to June 2023
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 16 Jul 2024.
- 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.
Ulf Dornseifer, MD/PhD study director
Head of Department plastic and reconstructive surgery ISAR Klinikum
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mammaplasty and Microsurgery, run by ISAR Klinikum at 2 sites in Germany.
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 2 inclusion and 2 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 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Magnetic resonance imaging (MRI) scans: soft tissue sinking of the recipient vessels area (time frame: October 2021 to June 2023). 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 16 Jul 2024; AzTrials last refreshed its copy on 30 Oct 2026.