MastectomyNCT03959709
Pre-pectoral Versus Sub-pectoral Implant Placement in Immediate Breast Reconstruction
A study testing immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement. and Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement in people with Mastectomy and Breast Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Despite the popularity and proved safety of prepectoral implant-based reconstruction, there is little evidence on long-term results and variables which could influence surgical outcome. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Mastectomy, Breast Cancer
- What is being tested?
- immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement. and Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 22 Aug 2019to 30 Dec 2023
- 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 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient
- Ages 20-80
- All patients undergoing mastectomy for breast cancer or prophylaxis for breast cancer with immediate implant-based reconstruction
- Able to provide informed consent
Who cannot join
- Patients who have had prior chest wall or irradiation on the reconstructed side
- Patients not undergoing immediate breast reconstruction at the time of mastectomy
- Any patient with a contraindication to immediate breast reconstruction.
- Patients with history of smoking, BMI> 40, and D cup breast size or grade III ptosis are all contraindications to immediate breast reconstruction as the risk of postoperative complications are significantly higher (wound infection, dehiscence, implant loss, seroma) than the average patient and thus these patients would be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
Jing Zhang
Jing Zhang, MD
About this study
Official title: A Randomized Controlled Trial Comparing the Pre-pectoral Versus Sub-pectoral Implant Placement in Immediate Breast Reconstruction
Despite the popularity and proved safety of prepectoral implant-based reconstruction, there is little evidence on long-term results and variables which could influence surgical outcome. So far, no specific guidelines or indications have been developed for prepectoral technique and heterogeneous inclusion criteria had been used in previous reports. There is a lack of studies documenting outcomes following ADM-assisted prepectoral breast reconstruction, and there are no randomised controlled trial studies that drawing a direct comparison of clinical or patient-reported outcomes between subpectoral and prepectoral groups.
The investigators hypothesized that immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement would result in less early postoperative pain but more reported implant rippling, requirement of more fat grafting and an equitable safety profile compared with ADM-assisted implant-based breast reconstruction with subpectoral implant placement.
The aim of this study is to evaluate the postsurgical pain, complications and patient-reported outcomes of prepectoral breast reconstruction versus subpectoral implant placement in immediate breast reconstruction.
Read the detailed description
The investigators will employ a single centre RCT with duration of two years (July 1, 2019 - June 30, 2021). Participant recruitment and enrolment will occur at the Women's Health Center for 1 year (July 1, 2019 to June 30, 2020), followed by one year (June 30, 2021) of follow-up data collection, data analyses and dissemination.
At the preoperative consultation, the surgeon will determine if the patient is eligible for implant-based immediate reconstruction, using the inclusion and exclusion criteria.
A total of 56 patients or 23 patients per arm will be recruited. Randomization will be accomplished using randomly permuted blocks, and the randomization list will be prepared by a biostatistician with no clinical involvement in this trial. Randomization will be stratified on the basis of center and laterality of reconstruction (i.e., unilateral versus bilateral reconstruction).
The allocation sequence will be concealed by placing each randomization assignment in a sequentially numbered, opaque, sealed envelope. Consecutive envelopes will be delivered to the operating room by the on-site research study assistant once the mastectomy is complete. To prevent subversion of the allocation sequence, envelopes will not be opened until the attending surgeon confirms the absence of significant mastectomy flap necrosis and the fact that the patient does not undergo a concurrent axillary lymph node dissection.
All patients will be blinded to their treatment arm. Once the treatment arm is revealed, the attending surgeon will advise the surgical team (surgical assistants and operating room nurses) the surgical plan. While the surgical team will be aware of the randomization code, the rest of the postoperative care team (including recovery room staff, day surgery nursing staff, and clinic staff during follow-up visit), outcome assessors, and data analysts will be kept blinded to the intervention performed.
Outcome measures:
At the baseline visit, following informed consent, demographic data (age, BMI, laterality and comorbidities) will be collected. The participant will then complete the following questionnaires: Pre-operative Breast-Q™: The Breast-Q™ Reconstruction Module is a validated PRO developed specifically for patients undergoing breast reconstruction. The questionnaire evaluates patient-reported satisfaction, psychosocial, physical and sexual quality of life [1] Primary outcome: Postoperative Pain scores and 24-hour narcotic consumption Secondary outcomes: All outcomes are measured within or at 12 months of the initial surgery.
- Conditions
- Mastectomy, Breast Cancer
- Being tested
- immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement., Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.Procedure or surgery
On the day of surgery, after the completion of the mastectomy, the vascularity of the mastectomy flaps will be evaluated, and debridement is performed where necessary. A temporary implant sizer is placed in the pocket to assess the position and shape of the prepectoral pocket. The pocket is adjusted where necessary. A sheet of ADM (DermAcell) is then selected. The DermAcell will be prepared as per the manufacture's instructions and fenestrated using size 11 blade. The DermACELL piece will be trimmed to the appropriate shape and sutured to the superior medial and lateral edges of the pectoralis major muscle. The inferior edge will be sutured to the fascia at the level of the inframammary fold. Two closed suction drains will be placed (one below the mastectomy skin flap, and one below DermACELL). The implant will be inserted to the pre-pectoral pocket and several anchor sutures will be used to secure the superior-medial edge of DermACELL to mastectomy flap.
Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placementProcedure or surgery
On the day of surgery, after the completion of the mastectomy, the vascularity of the mastectomy flaps will be evaluated, and debridement is performed where necessary. The reconstructive operative procedure will then proceeded with (1) elevation of the pectoralis major muscle with release of inferior attachments; (2) placement of implant subpectorally; (3) placement and suturing of DermACELL to constitute the inferolateral breast pocket; (4) placement of two closed suction drains (one superiorly between the pectoralis major and skin, and one inferiorly between the DermACELL and skin); (5) removal of sizer and placement of permanent to the pocket and (6) suture the inferior edge of DermACELL to the inferior edge of the pectoral major muscle. The skin will be closed and the dressing will be applied as standard protocol.
| Study group | Role | What they receive |
|---|---|---|
| Prepectoral implant placement | Experimental | Immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement. Receives: Procedure: immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement. |
| Subpectoral implant placement | Active comparator | Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement. Receives: Procedure: Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain and 24-hour narcotic consumption
Postoperative Pain will be scored using Numerical rating scale. The scale ranges from 0 to 10 indicating the level of pain. Zero indicates the absence of pain, while 10 represents the most intense pain (no pain = 0, mild = 1-3, moderate = 4-6, severe = 7-10).
Measured: 24 hours
Secondary outcomes (9)
Mastectomy flap necrosis
Skin loss of mastectomy flap
Measured: 4 weeks
Rate of seroma
Episodes of seroma formation requiring aspiration
Measured: 4 weeks
Rate of infection
Cellulitis and abscess
Measured: 3 months
Rate of Explantation
Loss of implant
Measured: 1 year
Number of Revisional surgeries
return to operating room for more surgeries
Measured: 1 year
Rate of Wound
incision dehiscence or debridement
Measured: 3 months
Rate of Capsular contracture
Tightening, firmness and pain of reconstructive breast
Measured: 1 year
BREAST-Q© Pre-operative scale
The BREAST-Q© modules is comprised of the following two overarching themes (or domains): 1) Health-Related Quality of Life (QOL) and 2) Patient Satisfaction. Under each of these domains, there are six subthemes; QOL: 1) Psychosocial, 2) Physical and 3) Sexual well-being; and Patient Satisfaction: 4) Satisfaction with Breasts, 5) Satisfaction with Outcome and 6) Satisfaction with Care. Body image is an important concept for breast surgery patients. Preoperative scales: Satisfaction with Breasts, Psychosocial, Sexual and Physical Well-being Chest
There is no overall or total BREAST-Q© score, only scores for each independent scale. All BREAST-Q© scales are transformed into scores that range from 0-100. The scores are computed by adding the response items together and then converting the raw sum scale score to a score from 0-100. For all BREAST-Q© scales, a higher score means greater satisfaction or better QOL (depending on the scale). The score is from 0 (worst) to 100 (best).
Measured: Before Surgery
BREAST-Q© Post-operative
The BREAST-Q© modules is comprised of the following two overarching themes (or domains): 1) Health-Related Quality of Life (QOL) and 2) Patient Satisfaction. Under each of these domains, there are six subthemes; QOL: 1) Psychosocial, 2) Physical and 3) Sexual well-being; and Patient Satisfaction: 4) Satisfaction with Breasts, 5) Satisfaction with Outcome and 6) Satisfaction with Care. Body image is an important concept for breast surgery patients.
Postoperative scales: Satisfaction with Doctor, Medical Team and Office Staff
There is no overall or total BREAST-Q© score, only scores for each independent scale. All BREAST-Q© scales are transformed into scores that range from 0-100. The scores are computed by adding the response items together and then converting the raw sum scale score to a score from 0-100. For all BREAST-Q© scales, a higher score means greater satisfaction or better QOL (depending on the scale).
The score is from 0 (worst) to 100 (best).
Measured: 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start22 Aug 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (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 Ottawa Hospital Research InstituteThe 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, Care provider, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959709
- Sponsor's protocol ID
- 1449
- Status last verified
- Apr 2022
- First submitted
- 10 May 2019
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Pre-pectoral Versus Sub-pectoral Implant Placement in Immediate Breast Reconstruction
- ClinicalTrials.gov ID
- NCT03959709
- Acronym / sponsor ID
- 1449
- Conditions
- Mastectomy, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 22 May 2019 (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.
Despite the popularity and proved safety of prepectoral implant-based reconstruction, there is little evidence on long-term results and variables which could influence surgical outcome. So far, no specific guidelines or indications have been developed for prepectoral technique and heterogeneous inclusion criteria had been used in previous reports. There is a lack of studies documenting outcomes following ADM-assisted prepectoral breast reconstruction, and there are no randomised controlled trial studies that drawing a direct comparison of clinical or patient-reported outcomes between subpectoral and prepectoral groups.
The investigators hypothesized that immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement would result in less early postoperative pain but more reported implant rippling, requirement of more fat grafting and an equitable safety profile compared with ADM-assisted implant-based breast reconstruction with subpectoral implant placement.
The aim of this study is to evaluate the postsurgical pain, complications and patient-reported outcomes of prepectoral breast reconstruction versus subpectoral implant placement in immediate breast reconstruction.
Detailed description
The investigators will employ a single centre RCT with duration of two years (July 1, 2019 - June 30, 2021). Participant recruitment and enrolment will occur at the Women's Health Center for 1 year (July 1, 2019 to June 30, 2020), followed by one year (June 30, 2021) of follow-up data collection, data analyses and dissemination.
At the preoperative consultation, the surgeon will determine if the patient is eligible for implant-based immediate reconstruction, using the inclusion and exclusion criteria.
A total of 56 patients or 23 patients per arm will be recruited. Randomization will be accomplished using randomly permuted blocks, and the randomization list will be prepared by a biostatistician with no clinical involvement in this trial. Randomization will be stratified on the basis of center and laterality of reconstruction (i.e., unilateral versus bilateral reconstruction).
The allocation sequence will be concealed by placing each randomization assignment in a sequentially numbered, opaque, sealed envelope. Consecutive envelopes will be delivered to the operating room by the on-site research study assistant once the mastectomy is complete. To prevent subversion of the allocation sequence, envelopes will not be opened until the attending surgeon confirms the absence of significant mastectomy flap necrosis and the fact that the patient does not undergo a concurrent axillary lymph node dissection.
All patients will be blinded to their treatment arm. Once the treatment arm is revealed, the attending surgeon will advise the surgical team (surgical assistants and operating room nurses) the surgical plan. While the surgical team will be aware of the randomization code, the rest of the postoperative care team (including recovery room staff, day surgery nursing staff, and clinic staff during follow-up visit), outcome assessors, and data analysts will be kept blinded to the intervention performed.
Outcome measures:
At the baseline visit, following informed consent, demographic data (age, BMI, laterality and comorbidities) will be collected. The participant will then complete the following questionnaires: Pre-operative Breast-Q™: The Breast-Q™ Reconstruction Module is a validated PRO developed specifically for patients undergoing breast reconstruction. The questionnaire evaluates patient-reported satisfaction, psychosocial, physical and sexual quality of life [1] Primary outcome: Postoperative Pain scores and 24-hour narcotic consumption Secondary outcomes: All outcomes are measured within or at 12 months of the initial surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prepectoral implant placement | Experimental | Procedure: immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.Immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement. |
| Subpectoral implant placement | Active comparator | Procedure: Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placementImmediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female patient
- Ages 20-80
- All patients undergoing mastectomy for breast cancer or prophylaxis for breast cancer with immediate implant-based reconstruction
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Patients who have had prior chest wall or irradiation on the reconstructed side
- Patients not undergoing immediate breast reconstruction at the time of mastectomy
- Any patient with a contraindication to immediate breast reconstruction.
- Patients with history of smoking, BMI> 40, and D cup breast size or grade III ptosis are all contraindications to immediate breast reconstruction as the risk of postoperative complications are significantly higher (wound infection, dehiscence, implant loss, seroma) than the average patient and thus these patients would be excluded from the study.
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 |
|---|---|---|
| immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.On the day of surgery, after the completion of the mastectomy, the vascularity of the mastectomy flaps will be evaluated, and debridement is performed where necessary. A temporary implant sizer is placed in the pocket to assess the position and shape of the prepectoral pocket. The pocket is adjusted where necessary. A sheet of ADM (DermAcell) is then selected. The DermAcell will be prepared as per the manufacture's instructions and fenestrated using size 11 blade. The DermACELL piece will be trimmed to the appropriate shape and sutured to the superior medial and lateral edges of the pectoralis major muscle. The inferior edge will be sutured to the fascia at the level of the inframammary fold. Two closed suction drains will be placed (one below the mastectomy skin flap, and one below DermACELL). The implant will be inserted to the pre-pectoral pocket and several anchor sutures will be used to secure the superior-medial edge of DermACELL to mastectomy flap. | Procedure or surgery | Prepectoral implant placement |
| Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placementOn the day of surgery, after the completion of the mastectomy, the vascularity of the mastectomy flaps will be evaluated, and debridement is performed where necessary. The reconstructive operative procedure will then proceeded with (1) elevation of the pectoralis major muscle with release of inferior attachments; (2) placement of implant subpectorally; (3) placement and suturing of DermACELL to constitute the inferolateral breast pocket; (4) placement of two closed suction drains (one superiorly between the pectoralis major and skin, and one inferiorly between the DermACELL and skin); (5) removal of sizer and placement of permanent to the pocket and (6) suture the inferior edge of DermACELL to the inferior edge of the pectoral major muscle. The skin will be closed and the dressing will be applied as standard protocol. | Procedure or surgery | Subpectoral implant placement |
Primary outcome
Postoperative Pain and 24-hour narcotic consumption
Time frame: 24 hours
Postoperative Pain will be scored using Numerical rating scale. The scale ranges from 0 to 10 indicating the level of pain. Zero indicates the absence of pain, while 10 represents the most intense pain (no pain = 0, mild = 1-3, moderate = 4-6, severe = 7-10).
9 secondary outcomes
Mastectomy flap necrosis
Time frame: 4 weeks
Rate of seroma
Time frame: 4 weeks
Rate of infection
Time frame: 3 months
Rate of Explantation
Time frame: 1 year
Number of Revisional surgeries
Time frame: 1 year
Rate of Wound
Time frame: 3 months
Rate of Capsular contracture
Time frame: 1 year
BREAST-Q© Pre-operative scale
Time frame: Before Surgery
BREAST-Q© Post-operative
Time frame: 3 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- 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.
Jing Zhang, MD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement. and Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement in people with Mastectomy and Breast Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 4 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 27 Apr 2022. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Zhang, MD ((613) 798-5555 ext. 13165, jzhang1@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain and 24-hour narcotic consumption (time frame: 24 hours). 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 27 Apr 2022.