Abdominal Donor-siteNCT02076724
Reinforcement of the Abdominal Wall After Breast Reconstruction With the Pedicled TRAM-flap
A study testing Biological mesh and Synthetic mesh in people with Abdominal Donor-site, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to compare two methods for reinforcement of the abdominal donor-site after breast reconstruction with the pedicled TRAM-flap. Reinforcement of the abdominal donor-site is performed, after randomization, with either a porcine derived biological mesh or a synthetic mesh. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abdominal Donor-site
- What is being tested?
- Biological mesh and Synthetic mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Mar 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Immediate or delayed breast reconstruction using the pedicled TRAM-flap
- Older than 18 years of age
- Understand enough Danish to comprehend the given information and to complete the study questionnaire
- Verbal and written informed consent
Who cannot join
- Current smokers
- Not eligible patients, assessed by surgeon
- High level of co-morbidity, assessed by surgeon or anesthesiologist
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Plastic and Reconstructive Surgery, Aarhus University Hospital
Aarhus C, Aarhus, 8000
About this study
Official title: Reinforcement of the Abdominal Wall With Acellular Dermal Matrix (Strattice™) After Breast Reconstruction With the Pedicled TRAM-flap
The purpose of this study is to compare two methods for reinforcement of the abdominal donor-site after breast reconstruction with the pedicled TRAM-flap. Reinforcement of the abdominal donor-site is performed, after randomization, with either a porcine derived biological mesh or a synthetic mesh. The patient and the investigator is blinded.
The aim is to identify the most optimal method for reinforcement of the abdominal donor-site and thereby contribute to fast and complete rehabilitation of women undergoing breast reconstruction with the pedicled TRAM-flap after surgical removal of the breast tissue due to breast cancer, precursors to breast cancer or an increased risk of developing breast cancer and thereby following preventive removal of the breast tissue.
The patients visit the outpatient clinic 4, 12 and 24 months after operation and abdominal wall function, the donor site morbidity, the frequency of postoperative complications, the aesthetic appearance of the reconstructed breast and the abdominal wall and costs are evaluated.
- Conditions
- Abdominal Donor-site
- Being tested
- Biological mesh, Synthetic mesh
- Keywords
- Abdominal donor-site, Breast reconstruction, Synthetic mesh, Biological mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological meshDevice
Also called Strattice Reconstructive Tissue Matrix Firm, LifeCell Corp.
Synthetic meshDevice
Also called Prolene mesh, Ethicon
| Study group | Role | What they receive |
|---|---|---|
| Biological mesh (Strattice Firm) | Experimental | Strattice Firm is inserted using inlay technique as reinforcement of the abdominal wall where the anterior rectus fascia has been excised. Receives: Device: Biological mesh |
| Synthetic mesh (Prolene) | Experimental | Prolene mesh is inserted using inlay technique as reinforcement of the abdominal wall where the anterior rectus fascia has been excised. Receives: Device: Synthetic mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal wall function change
Strength of abdominal wall is assessed by a standardized physical examination developed in collaboration with physiotherapists. A dynamometer is used to get an exact value of muscle strength.
Measured: Change from before surgery to 12 and 24 months after surgery
Secondary outcomes (4)
Abdominal donor site morbidity
Bulge
- Definition: visible abdominal contour abnormality, without the presence of a fascial defect, with or without the need for surgical correction.
- Assessed after 3-4, 12 and 24 months by clinical examination and after 12 and 24 months by CT scanning including the Valsalva maneuver
Hernia
- Definition: abdominal wall bulge with the presence of a palpable fascial defect and/or a fascial defect found during an additional correcting surgical procedure or by CT scanning.
- Assessed after 3-4, 12 and 24 months by clinical examination and after 12 and 24 months by CT scanning including the Valsalva maneuver
Abdominal donor site correction procedure (within 24 months)
Pain/ discomfort
- Assessed after 3-4, 12 and 24 months by
- DoloTest®
- Study specific questionnaire regarding postoperative assessment of abdominal pain/ discomfort including effect on daily life activities and ability to perform sport
Measured: 24 months
Aesthetics at the abdominal wall
Study specific questionnaire regarding postoperative assessment of the outcome including:
- Overall satisfaction with the appearance of the abdominal donor site
- Satisfaction regarding placement and the appearance of the umbilicus
Investigators assessment of the abdominal donor site including:
- Visual bulging of the lower abdomen
- Placement and appearance of the umbilicus
- Appearance of the scar
Measured: 24 months
Costs
National health insurance rate Cost of Strattice (LifeCell), Prolene mesh (Ethicon) Operation time Hospitalization Time to return to work / Duration of sick leave Post-reconstruction procedures to address complications at the abdominal donor site.
Measured: 24 months
Postoperative complications
Hematoma requiring surgical intervention. Cellulitis/ wound infection not requiring surgical intervention but treatment with antibiotics.
Infection requiring surgical intervention. Seroma requiring intervention Donor site necrosis (present necrosis - excluding epidermolysis, in the umbilical area or in the remaining abdominal skin and subcutaneous tissue requiring surgical intervention)
Measured: Acute <1 month, ≥ 1 month-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJan 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Donor-siteStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LifeCell, Novo Nordisk A/S, University of Aarhus
- Responsible party
- Principal investigator, Mette Eline Brunbjerg, MD, Aarhus University Hospital
- Investigators
- Mette Eline Brunbjerg, MD, Principal investigator, Aarhus University Hospital and Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076724
- Sponsor's protocol ID
- VEK 1-10-72-10-13
- Status last verified
- Jan 2020
- First submitted
- 26 Feb 2014
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reinforcement of the Abdominal Wall With Acellular Dermal Matrix (Strattice™) After Breast Reconstruction With the Pedicled TRAM-flap
- ClinicalTrials.gov ID
- NCT02076724
- Acronym / sponsor ID
- VEK 1-10-72-10-13
- Conditions
- Abdominal Donor-site
- Keywords
- Abdominal donor-site, Breast reconstruction, Synthetic mesh, Biological mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- LifeCell, Novo Nordisk A/S, University of Aarhus
- Study start
- Mar 2014 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 4 Mar 2014 (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.
The purpose of this study is to compare two methods for reinforcement of the abdominal donor-site after breast reconstruction with the pedicled TRAM-flap. Reinforcement of the abdominal donor-site is performed, after randomization, with either a porcine derived biological mesh or a synthetic mesh. The patient and the investigator is blinded.
The aim is to identify the most optimal method for reinforcement of the abdominal donor-site and thereby contribute to fast and complete rehabilitation of women undergoing breast reconstruction with the pedicled TRAM-flap after surgical removal of the breast tissue due to breast cancer, precursors to breast cancer or an increased risk of developing breast cancer and thereby following preventive removal of the breast tissue.
The patients visit the outpatient clinic 4, 12 and 24 months after operation and abdominal wall function, the donor site morbidity, the frequency of postoperative complications, the aesthetic appearance of the reconstructed breast and the abdominal wall and costs are evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biological mesh (Strattice Firm) | Experimental | Device: Biological meshStrattice Firm is inserted using inlay technique as reinforcement of the abdominal wall where the anterior rectus fascia has been excised. |
| Synthetic mesh (Prolene) | Experimental | Device: Synthetic meshProlene mesh is inserted using inlay technique as reinforcement of the abdominal wall where the anterior rectus fascia has been excised. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Immediate or delayed breast reconstruction using the pedicled TRAM-flap
- Older than 18 years of age
- Understand enough Danish to comprehend the given information and to complete the study questionnaire
- Verbal and written informed consent
Key exclusion criteria (3 listed)
- Current smokers
- Not eligible patients, assessed by surgeon
- High level of co-morbidity, assessed by surgeon or anesthesiologist
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 |
|---|---|---|
| Biological meshAlso: Strattice Reconstructive Tissue Matrix Firm, LifeCell Corp. | Device | Biological mesh (Strattice Firm) |
| Synthetic meshAlso: Prolene mesh, Ethicon | Device | Synthetic mesh (Prolene) |
Primary outcome
Abdominal wall function change
Time frame: Change from before surgery to 12 and 24 months after surgery
Strength of abdominal wall is assessed by a standardized physical examination developed in collaboration with physiotherapists. A dynamometer is used to get an exact value of muscle strength.
4 secondary outcomes
Abdominal donor site morbidity
Time frame: 24 months
Aesthetics at the abdominal wall
Time frame: 24 months
Costs
Time frame: 24 months
Postoperative complications
Time frame: Acute <1 month, ≥ 1 month-24 months
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 9 Jan 2020.
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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.
Mette Eline Brunbjerg, MD principal investigator
Aarhus University Hospital and Aarhus 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 Biological mesh and Synthetic mesh in people with Abdominal Donor-site, run by Aarhus University Hospital at 1 site in Denmark.
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 4 inclusion and 3 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 9 Jan 2020. 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 Denmark. 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?
Abdominal wall function change (time frame: Change from before surgery to 12 and 24 months after surgery). 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 9 Jan 2020.