Breast; Deformity, CongenitalPhase 4NCT03197103
The Impact of N-Acetylcysteine on Volumetric Retention of Autologous Fat Graft for Breast Asymmetry Correction
A Phase 4 study testing N-Acetylcysteine (NAC) in people with Breast; Deformity, Congenital and Graft Loss, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
The aim of this study is to assess the effect of new tumescent solution for liposuction containing N-Acetylcysteine (Pietruski solution) on the autologous fat graft volumetric retention used for healthy women breast asymmetry correction by means of lipofilling. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breast; Deformity, Congenital, Graft Loss, Adipose Tissue Atrophy
- What is being tested?
- N-Acetylcysteine (NAC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 sitePoland
- Study dates
- 4 Jul 2017to 1 May 2018
- Phase
- Phase 4
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Age 18-40 years
- BMI > 20
- Breasts asymmetry (including tuberous breasts deformity) with indications for treatment with autologous fat grafting
- ASA PS I
Who cannot join
- Asthma
- A history of allergic reaction to NAC
- Peptic ulcer disease
- Contraindications to MRI imaging
- A history of breast surgery or radiotherapy
- A history of hip/thigh surgery or injury
- Breastfeeding, pregnancy or planned pregnancy within a year
- Ilness or general state of health precluding general anesthesia
Trial locations and contacts
1 site in 1 country.
Poland1 site
Centre of Postgraduate Medical Education, Prof. W. Orlowski Memorial Hospital
Warsaw, Mazowiecki, 00416
About this study
The aim of this study is to assess the effect of new tumescent solution for liposuction containing N-Acetylcysteine (Pietruski solution) on the autologous fat graft volumetric retention used for healthy women breast asymmetry correction by means of lipofilling.
Read the detailed description
Lipofilling is the process of relocating autologous fat to change the volume, shape, and profile of tissues. It is considered a simple, inexpensive and minimally invasive technique indicated for both congenital and acquired soft tissue defects in many sites. Success is heavily dependent on the harvesting technique, preparing and injection of the fat. The main limitation of the abovementioned surgical procedure is a loss of transplanted adipose tissue which is believed to be caused mainly by cells injury in oxidative, ischemic, and mechanical stress mechanism. High graft resorption rate results in undercorrection and requirement for multiple-stage treatment. The aim of this study is to assess the effect of new tumescent solution for liposuction containing N-Acetylcysteine (NAC) on the autologous fat graft volumetric retention used for healthy women breast asymmetry correction by means of lipofilling. NAC reduces free radicals using a sulfhydryl chemical group. In authors opinion, this antioxidant effect may decrease oxidative stress experienced by adipose graft cells during the harvest procedure, therefore potentially improving the long-term survivability of the fat graft, lowering the number of re-operations and even maybe the total volume of fat graft needed to achieve satisfactory results. The results of this study may justify the usage of novel tumescent solution (Pietruski solution) for autologous adipose tissue graft harvest in the routine clinical setting.
The subjects for this project will consist of the group of women who are candidates for hypoplastic, asymmetric breasts correction with at least two-staged lipofilling procedure. The bilateral character of such defect allows for each patient to serve as her own control. In the first lipofilling procedure one breast will be enlarged with autologous fat graft harvested from one thigh region after its infiltration with Pietruski solution. The contralateral breast will be enlarged with adipose tissue collected from contralateral thigh area by performing lipoaspiration after standard tumescent solution infiltration. Only the first stage of breasts defect correction is included in this study. Additional, future lipofilling procedures will utilize fat graft obtained with a standard tumescent solution only.
The hypothesis that addition of NAC to the tumescent solution used for the fat graft harvest procedure will decrease its long-term resorption in breast region will be tested in comparison to the fat graft obtained with liposuction using standard tumescent solution. For each subject, a breast magnetic resonance imaging (MRI) will be performed before and six months after the first fat graft transfer enabling quantitative, volumetric analysis of the transplanted adipose tissue resorption. In addition, a volume of 50 ml of each harvested fat graft will be intended for genetic and immunohistochemical analysis. The results will be compared using two-tailed t-tests with statistical significance set at p<0.05.
The study will be conducted at the Plastic Surgery Department, Centre of Postgraduate Medical Education, Warsaw, Poland.
- Being tested
- N-Acetylcysteine (NAC)
- Keywords
- Autologous fat grafting, Breast, Deformity, Asymmetry, Tuberous breast, Acetylcysteine
- Medical subject headings
- Congenital Abnormalities, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetylcysteine (NAC)Drug
Also called Acetylcysteine
For more information read Experimental Arm description
| Study group | Role | What they receive |
|---|---|---|
| N-Acetylcysteine (NAC) | Experimental | Breast enlargement with autologous fat graft obtained by liposuction with Pietruski solution (tumescent solution with NAC). Receives: Drug: N-Acetylcysteine (NAC) |
| Control | No intervention | Contralateral breast enlargement with autologous fat graft obtained by liposuction with standard tumescent solution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autologous fat graft volumetric analysis
Volumetric analysis of fat graft six months after operation (postoperative breast adipose tissue volume in comparison to preoperative volume).
Measured: 6 months following the intervention in the last enrolled participant
Secondary outcomes (3)
Intraoperative complications
Any complication that occurred during the lipofilling procedure.
Measured: During intervention (operation)
Postoperative complications
Any complication or adverse effect of the lipofilling procedure that occurred in the six-month time frame following the operation.
Measured: 6 months following the intervention
Immunohistochemical and genetic analysis of lipoaspirates.
A volume of at least 50 ml of each harvested fat graft (control tumescent solution vs Pietruski tumescent solution) will be intended for genetic and immunohistochemical analysis. The immediate analysis will include oxidative stress markers quantification (Nitric Oxide, Superoxide dismutase, Reactive Oxygen Species), dead cell count evaluation (flow cytometry) and RNA isolation for the future qRT-PCR analysis of chosen targets expression related to cells' stress response. Additional, an attempt will be taken to isolate adipose-derived stem cells (ASC) from each lipoaspirate for the purpose of hydrogen peroxide exposure test, ELISA test, flow cytometry, Colony Forming Unit-Fibroblastic Assay (CFU-F) and Cell Proliferation Assay.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start4 Jul 2017
- Primary completion1 Mar 2018 (estimated)
- Study completion1 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast; Deformity, CongenitalStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bartłomiej Noszczyk, Centre of Postgraduate Medical Education
- Investigators
- Bartłomiej Noszczyk, Ph.D., M.D., Study director, Centre of Postgraduate Medical EducationPiotr Pietruski, M.D., Principal investigator, Centre of Postgraduate Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197103
- Sponsor's protocol ID
- 58/IX/PB/Noszczyk/16
- Status last verified
- Jul 2017
- First submitted
- 21 Jun 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pietruski P, Paskal W, Paluch L, Paskal AM, Nitek Z, Wlodarski P, Walecki J, Noszczyk B. The Impact of N-Acetylcysteine on Autologous Fat Graft: First-in-Human Pilot Study. Aesthetic Plast Surg. 2020 May 18. doi: 10.1007/s00266-020-01730-1. Online ahead of print.
PubMed 32424535Pietruski P, Paskal W, Paluch L, Paskal AM, Nitek Z, Wlodarski P, Walecki J, Noszczyk B. The Impact of N-Acetylcysteine on Autologous Fat Graft: First-in-Human Pilot Study. Aesthetic Plast Surg. 2021 Oct;45(5):2397-2405. doi: 10.1007/s00266-020-01633-1. Epub 2020 Mar 27.
PubMed 32221675
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of N-Acetylcysteine on Volumetric Retention of Autologous Fat Graft for Breast Asymmetry Correction
- ClinicalTrials.gov ID
- NCT03197103
- Acronym / sponsor ID
- 58/IX/PB/Noszczyk/16
- Keywords
- Autologous fat grafting, Breast, Deformity, Asymmetry, Tuberous breast, Acetylcysteine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 May 2018 (estimated)
- First posted
- 23 Jun 2017 (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.
The aim of this study is to assess the effect of new tumescent solution for liposuction containing N-Acetylcysteine (Pietruski solution) on the autologous fat graft volumetric retention used for healthy women breast asymmetry correction by means of lipofilling.
Detailed description
Lipofilling is the process of relocating autologous fat to change the volume, shape, and profile of tissues. It is considered a simple, inexpensive and minimally invasive technique indicated for both congenital and acquired soft tissue defects in many sites. Success is heavily dependent on the harvesting technique, preparing and injection of the fat. The main limitation of the abovementioned surgical procedure is a loss of transplanted adipose tissue which is believed to be caused mainly by cells injury in oxidative, ischemic, and mechanical stress mechanism. High graft resorption rate results in undercorrection and requirement for multiple-stage treatment. The aim of this study is to assess the effect of new tumescent solution for liposuction containing N-Acetylcysteine (NAC) on the autologous fat graft volumetric retention used for healthy women breast asymmetry correction by means of lipofilling. NAC reduces free radicals using a sulfhydryl chemical group. In authors opinion, this antioxidant effect may decrease oxidative stress experienced by adipose graft cells during the harvest procedure, therefore potentially improving the long-term survivability of the fat graft, lowering the number of re-operations and even maybe the total volume of fat graft needed to achieve satisfactory results. The results of this study may justify the usage of novel tumescent solution (Pietruski solution) for autologous adipose tissue graft harvest in the routine clinical setting.
The subjects for this project will consist of the group of women who are candidates for hypoplastic, asymmetric breasts correction with at least two-staged lipofilling procedure. The bilateral character of such defect allows for each patient to serve as her own control. In the first lipofilling procedure one breast will be enlarged with autologous fat graft harvested from one thigh region after its infiltration with Pietruski solution. The contralateral breast will be enlarged with adipose tissue collected from contralateral thigh area by performing lipoaspiration after standard tumescent solution infiltration. Only the first stage of breasts defect correction is included in this study. Additional, future lipofilling procedures will utilize fat graft obtained with a standard tumescent solution only.
The hypothesis that addition of NAC to the tumescent solution used for the fat graft harvest procedure will decrease its long-term resorption in breast region will be tested in comparison to the fat graft obtained with liposuction using standard tumescent solution. For each subject, a breast magnetic resonance imaging (MRI) will be performed before and six months after the first fat graft transfer enabling quantitative, volumetric analysis of the transplanted adipose tissue resorption. In addition, a volume of 50 ml of each harvested fat graft will be intended for genetic and immunohistochemical analysis. The results will be compared using two-tailed t-tests with statistical significance set at p<0.05.
The study will be conducted at the Plastic Surgery Department, Centre of Postgraduate Medical Education, Warsaw, Poland.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-Acetylcysteine (NAC) | Experimental | Drug: N-Acetylcysteine (NAC)Breast enlargement with autologous fat graft obtained by liposuction with Pietruski solution (tumescent solution with NAC). |
| Control | No intervention | –Contralateral breast enlargement with autologous fat graft obtained by liposuction with standard tumescent solution. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female
- Age 18-40 years
- BMI > 20
- Breasts asymmetry (including tuberous breasts deformity) with indications for treatment with autologous fat grafting
- ASA PS I
Key exclusion criteria (8 listed)
- Asthma
- A history of allergic reaction to NAC
- Peptic ulcer disease
- Contraindications to MRI imaging
- A history of breast surgery or radiotherapy
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 |
|---|---|---|
| N-Acetylcysteine (NAC)Also: AcetylcysteineFor more information read Experimental Arm description | Drug | N-Acetylcysteine (NAC) |
Primary outcome
Autologous fat graft volumetric analysis
Time frame: 6 months following the intervention in the last enrolled participant
Volumetric analysis of fat graft six months after operation (postoperative breast adipose tissue volume in comparison to preoperative volume).
3 secondary outcomes
Intraoperative complications
Time frame: During intervention (operation)
Postoperative complications
Time frame: 6 months following the intervention
Immunohistochemical and genetic analysis of lipoaspirates.
Time frame: Immediately after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Derived from this study: PubMed 32424535Pietruski P, Paskal W, Paluch L, Paskal AM, Nitek Z, Wlodarski P, Walecki J, Noszczyk B. The Impact of N-Acetylcysteine on Autologous Fat Graft: First-in-Human Pilot Study. Aesthetic Plast Surg. 2020 May 18. doi: 10.1007/s00266-020-01730-1. Online ahead of print.
- Derived from this study: PubMed 32221675Pietruski P, Paskal W, Paluch L, Paskal AM, Nitek Z, Wlodarski P, Walecki J, Noszczyk B. The Impact of N-Acetylcysteine on Autologous Fat Graft: First-in-Human Pilot Study. Aesthetic Plast Surg. 2021 Oct;45(5):2397-2405. doi: 10.1007/s00266-020-01633-1. Epub 2020 Mar 27.
- 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.
Bartłomiej Noszczyk, Ph.D., M.D. study director
Centre of Postgraduate Medical Education
Piotr Pietruski, M.D. principal investigator
Centre of Postgraduate Medical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N-Acetylcysteine (NAC) in people with Breast; Deformity, Congenital and Graft Loss, run by Centre of Postgraduate Medical Education at 1 site in Poland.
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 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: status not confirmed, as of the sponsor's last update on 6 Jul 2017. 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 Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Autologous fat graft volumetric analysis (time frame: 6 months following the intervention in the last enrolled participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03197103, which also lists 2 linked publications.
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 6 Jul 2017.