Adipose Tissue AtrophyPhase 4NCT02788292
Effect of N-Acetylcysteine on Autologous Fat Graft Survival
A Phase 4 study testing Acetylcysteine in people with Adipose Tissue Atrophy and Deformity of Reconstructed Breast, run by Nova Scotia Health Authority.
Trial summary
A single-centre triple-blind study looking at the addition of NAC to tumescent solution for liposuction and fat grafting in healthy patient volunteers already undergoing bilateral breast reduction. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adipose Tissue Atrophy, Deformity of Reconstructed Breast, Graft Loss
- What is being tested?
- Acetylcysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2016to 16 Nov 2020
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- Desire and surgical indication for liposuction of the thigh/hip region for women already undergoing elective breast reduction surgery
- Age 18-45 years
- BMI of 20-30
- ASA Class I
Who cannot join
- Known chronic illnesses: Diabetes, HIV, renal/liver failure, metabolic disease, history of cancer or family pre-disposition of cancer, peripheral vascular disease, illness that would preclude a general anaesthetic
- Pregnancy or planned pregnancy within 1 year
- Contraindications to CT
- Previous hip/thigh surgery or injury
- Previous lower leg surgery/injury
- Smoker
- Breastfeeding
- Other disease according to investigator's judgment
About this study
A single-centre triple-blind study looking at the addition of NAC to tumescent solution for liposuction and fat grafting in healthy patient volunteers already undergoing bilateral breast reduction. Three-dimensional reconstructions and volumetric analysis will be performed based on CT scans at 0, 1 and 3 months and then histological analysis will be performed after fat graft explantation at 3 months to determine fat graft vascularity and quality.
Read the detailed description
Autologous fat grafting is an increasingly popular technique for soft tissue reconstruction; however, the surgical technique is limited by inconsistent graft take, undercorrection, and requirement for repeat procedures. The authors previously examined whether a widely available, clinically safe anti-oxidant, N-acetylcysteine (NAC), could improve adipose-derived stem cell survival and subsequent graft take when added to tumescent solution at the time of fat harvest in mice. The addition of NAC to tumescent fluid during fat harvest in mice protects ADSCs against oxidative stress, increases their survival and proliferation, and inhibits their early differentiation into mature adipocytes in vitro. In an in vivo model, NAC treatment at the time of harvest improved survival and quality of autologous fat grafts. These observations provide proof-of-principle for the use of NAC in the clinical setting to optimize fat graft yields.
Hypothesis: The addition of NAC to the tumescent solution used in fat grafting will improve fat graft survival in humans to potentially decrease the amount of re-operations and undercorrection that occurs.
Plan: The study will be conducted as a single-centre, randomized, triple-blind placebo-controlled trial to be performed at the QEII Health Sciences Centre, Halifax, Nova Scotia. Subjects will be chosen as healthy female patients already presenting to the operating room for elective breast reduction surgery. These patients will be enrolled and booked for surgery as they present to clinic and will not be expedited in receiving their elective surgery if enrolled in the study. Each subject will serve as her own control. The hypothesis will be tested by performing lipoaspiration of the thigh/hip region of healthy patients after the addition of tumescent solution with or without NAC. Approximately 10 millilitres of the fat graft will be injected into each pre-tibial area depending on the randomization allocation, as described by Kolle et al. (1) The volume of fat graft will be measured at 0, 1 and 3 months using computed tomographic (CT) scans according to institutional standards. The CT images will be exported into Materialise Interactive Medical Image Control System (MIMICS) and volumetric three-dimensional reconstructions will be made to measure the size and volume of the grafts at each of the time points. The grafts will then be explanted at 3 months and weighed. The histologic appearance, graded on the amount of inflammation, cysts/vacuoles, integrity and vascularity with CD31 staining will be assessed. The results will be compared using two-tailed t-tests. Statistical significance will be set at p<0.05.
- Being tested
- Acetylcysteine
- Keywords
- acetylcysteine, three-dimensional reconstruction, autologous fat grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetylcysteineDrug
Also called N-acetylcysteine
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Acetylcysteine (NAC) | Experimental | NAC added to tumescent solution for liposuction and eventual fat grafting. Receives: Drug: Acetylcysteine |
| Control | No intervention | Just tumescent solution for liposuction and fat grafting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fat graft volume over time
Based on CT scans of fat grafts and three-dimensional reconstructions/volumetric analysis
Measured: 0, 1 and 3 months
Secondary outcomes (4)
Weight of fat graft
Fat grafts will be explanted and weighed at 3 months.
Measured: 3 months
Fat graft vascularity
Vascularity of fat graft with CD31 staining.
Measured: 3 months
Fat graft quality
Quality of fat graft through histological analysis of cysts/vacuoles/intact fat cells/fibrosis and also through adipocyte slide coverage analysis.
Measured: 3 months
Adverse effects or complications
Collecting data regarding any adverse complications of the fat grafting procedure and subsequent recovery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start15 Aug 2016
- Primary completion16 Nov 2020
- Study completion16 Nov 2020
Why it stopped: unable to hire research staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adipose Tissue AtrophyStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788292
- Sponsor's protocol ID
- 1021326
- Status last verified
- Oct 2022
- First submitted
- 18 Apr 2016
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: IPD will not be available, but will be published as an average of outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of N-Acetylcysteine on Autologous Fat Graft Survival
- ClinicalTrials.gov ID
- NCT02788292
- Acronym / sponsor ID
- 1021326
- Keywords
- acetylcysteine, three-dimensional reconstruction, autologous fat grafting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to hire research staff
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 2 Jun 2016 (estimated)
- 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.
A single-centre triple-blind study looking at the addition of NAC to tumescent solution for liposuction and fat grafting in healthy patient volunteers already undergoing bilateral breast reduction. Three-dimensional reconstructions and volumetric analysis will be performed based on CT scans at 0, 1 and 3 months and then histological analysis will be performed after fat graft explantation at 3 months to determine fat graft vascularity and quality.
Detailed description
Autologous fat grafting is an increasingly popular technique for soft tissue reconstruction; however, the surgical technique is limited by inconsistent graft take, undercorrection, and requirement for repeat procedures. The authors previously examined whether a widely available, clinically safe anti-oxidant, N-acetylcysteine (NAC), could improve adipose-derived stem cell survival and subsequent graft take when added to tumescent solution at the time of fat harvest in mice. The addition of NAC to tumescent fluid during fat harvest in mice protects ADSCs against oxidative stress, increases their survival and proliferation, and inhibits their early differentiation into mature adipocytes in vitro. In an in vivo model, NAC treatment at the time of harvest improved survival and quality of autologous fat grafts. These observations provide proof-of-principle for the use of NAC in the clinical setting to optimize fat graft yields.
Hypothesis: The addition of NAC to the tumescent solution used in fat grafting will improve fat graft survival in humans to potentially decrease the amount of re-operations and undercorrection that occurs.
Plan: The study will be conducted as a single-centre, randomized, triple-blind placebo-controlled trial to be performed at the QEII Health Sciences Centre, Halifax, Nova Scotia. Subjects will be chosen as healthy female patients already presenting to the operating room for elective breast reduction surgery. These patients will be enrolled and booked for surgery as they present to clinic and will not be expedited in receiving their elective surgery if enrolled in the study. Each subject will serve as her own control. The hypothesis will be tested by performing lipoaspiration of the thigh/hip region of healthy patients after the addition of tumescent solution with or without NAC. Approximately 10 millilitres of the fat graft will be injected into each pre-tibial area depending on the randomization allocation, as described by Kolle et al. (1) The volume of fat graft will be measured at 0, 1 and 3 months using computed tomographic (CT) scans according to institutional standards. The CT images will be exported into Materialise Interactive Medical Image Control System (MIMICS) and volumetric three-dimensional reconstructions will be made to measure the size and volume of the grafts at each of the time points. The grafts will then be explanted at 3 months and weighed. The histologic appearance, graded on the amount of inflammation, cysts/vacuoles, integrity and vascularity with CD31 staining will be assessed. The results will be compared using two-tailed t-tests. Statistical significance will be set at p<0.05.
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 |
|---|---|---|
| Acetylcysteine (NAC) | Experimental | Drug: AcetylcysteineNAC added to tumescent solution for liposuction and eventual fat grafting. |
| Control | No intervention | –Just tumescent solution for liposuction and fat grafting. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women
- Desire and surgical indication for liposuction of the thigh/hip region for women already undergoing elective breast reduction surgery
- Age 18-45 years
- BMI of 20-30
- ASA Class I
Key exclusion criteria (8 listed)
- Known chronic illnesses: Diabetes, HIV, renal/liver failure, metabolic disease, history of cancer or family pre-disposition of cancer, peripheral vascular disease, illness that would preclude a general anaesthetic
- Pregnancy or planned pregnancy within 1 year
- Contraindications to CT
- Previous hip/thigh surgery or injury
- Previous lower leg surgery/injury
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 |
|---|---|---|
| AcetylcysteineAlso: N-acetylcysteineSee arm description | Drug | Acetylcysteine (NAC) |
Primary outcome
Change in fat graft volume over time
Time frame: 0, 1 and 3 months
Based on CT scans of fat grafts and three-dimensional reconstructions/volumetric analysis
4 secondary outcomes
Weight of fat graft
Time frame: 3 months
Fat graft vascularity
Time frame: 3 months
Fat graft quality
Time frame: 3 months
Adverse effects or complications
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No. IPD will not be available, but will be published as an average of outcomes.
Related trials for Adipose Tissue Atrophy
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
Exercise and Nutritional Intervention in Patients With Melanoma Receiving Immunotherapy
Melanoma
Recruiting
Using Strength Tests to Better Understand How Pancreatic Cancer Affects Muscle Mass and Quality of Life
Pancreatic Ductal Adenocarcinoma (PDAC), Hand Grip Strength
Not yet recruiting
Open Label, Multi-Center Study, Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System for Facial Fat Grafting
Facial Atrophy and Loss of Contour
Active, not recruitingEarly Phase 1
Ruxolitinib for Cancer Cachexia
Stage IV Non-small Cell Lung Cancer, Cachexia
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetylcysteine in people with Adipose Tissue Atrophy and Deformity of Reconstructed Breast, run by Nova Scotia Health Authority.
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: withdrawn, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in fat graft volume over time (time frame: 0, 1 and 3 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 21 Aug 2024.