SensitisationNCT04818190
DIEP (Deep Inferior Epigastric Artery Perforator) Flap Sensory Recovery Following Neurotization
A study testing Sensory neurotization in people with Sensitisation, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to compare the sensory return of DIEP flaps with nerve connection to DIEP flaps with no nerve connection to see which is better. This research is being done because the presence of sensation in a reconstructed breast has been shown to improve patient-related quality of life following… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sensitisation
- What is being tested?
- Sensory neurotization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2021to 1 May 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female subjects older than 18
- scheduled for immediate bilateral breast reconstruction following bilateral non-nipple sparing mastectomy
- using DIEP free flap reconstruction
- with a large skin paddle
Who cannot join
- pre-operative radiation or chemotherapy was performed
- post-operative radiation or chemotherapy is planned
- reconstruction is performed in a delayed fashion
- a nerve conduit is necessary for nerve coaptation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DIEP Flap Sensory Recovery Following Direct Neurotization in Breast Reconstruction - A Blinded Prospective Study
The purpose of this study is to compare the sensory return of DIEP flaps with nerve connection to DIEP flaps with no nerve connection to see which is better.
This research is being done because the presence of sensation in a reconstructed breast has been shown to improve patient-related quality of life following mastectomy reconstruction and is an important safety factor for prevention of burns and other flap injuries. Unfortunately, women who have breast skin excised during mastectomy are reconstructed with a traditional DIEP flap that does not restore sensation to the skin.
Read the detailed description
The Deep Inferior Epigastric Perforator (DIEP) flap is the current standard of care in breast reconstruction. The DIEP flap does not normally have sensation restored. The presence of sensation in a reconstructed breast has been shown to improve patient-rated quality of life following mastectomy and reconstruction and is an important safety factor for prevention of burns and other flap injuries. Unfortunately, women who have breast skin excised during mastectomy are reconstructed with a traditional DIEP flap that does not restore sensation to the skin. As such, the investigators aim to perform a prospective randomized single-blinded trial to evaluate sensory return to DIEP flaps following nerve coaptation.
A blinded, prospective study will be performed involving Manitoban women over 18 years undergoing bilateral breast reconstruction with DIEP flaps. The women will have one breast reconstructed in the standard of care (DIEP flap with no nerve coaptation) and one breast reconstructed with both DIEP flap and sensory nerve coaptation; the side of coaptation will be randomized. Objective sensibility to the breast will be tested pre- and post-operatively (3, 6, 12 months) using the Pressure Specified Sensory Device (PSSD). Patients will also complete the Breast Q questionnaire postoperatively.
- Conditions
- Sensitisation
- Being tested
- Sensory neurotization
- Keywords
- breast reconstruction, sensory recovery, DIEP reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory neurotizationProcedure or surgery
The donor nerve is a cutaneous nerve that is identified with the most inferior lateral perforator vessels. The nerve is then dissected for neurotization and divided at the level of the fascia where it is a pure sensory nerve. The recipient intercostal nerve is usually easily identified in the third intercostal space during the dissection of the internal mammary artery and vein. The anterior branch of the third intercostal nerve can usually be found at the junction of the inferior portion of the third rib and the sternum, approximately 80% of the time. The nerve is dissected and transected medially. It is then mobilized to give it the longest length possible in preparation for neurotization. Neurotization is performed by coapting the donor nerve to the third anterior intercostal nerve directly with a 9-0 nylon suture in standard fashion.
| Study group | Role | What they receive |
|---|---|---|
| DIEP reconstruction, no neurotization | No intervention | DIEP reconstruction No sensory neurotization |
| DIEP reconstruction, neurotization | Experimental | DIEP reconstruction With sensory neurotization Receives: Procedure: Sensory neurotization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory recovery to neurotized DIEP flap
Sensory recovery measured using Pressure Specified Sensory Device
Measured: 3 months post-operatively
Sensory recovery to neurotized DIEP flap
Sensory recovery measured using Pressure Specified Sensory Device
Measured: 6 months post-operatively
Sensory recovery to neurotized DIEP flap
Sensory recovery measured using Pressure Specified Sensory Device
Measured: 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Sep 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SensitisationStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Miller, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818190
- Sponsor's protocol ID
- HS24687
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 4 Oct 2021
- 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 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIEP Flap Sensory Recovery Following Direct Neurotization in Breast Reconstruction - A Blinded Prospective Study
- ClinicalTrials.gov ID
- NCT04818190
- Acronym / sponsor ID
- HS24687
- Conditions
- Sensitisation
- Keywords
- breast reconstruction, sensory recovery, DIEP reconstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 26 Mar 2021 (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 purpose of this study is to compare the sensory return of DIEP flaps with nerve connection to DIEP flaps with no nerve connection to see which is better.
This research is being done because the presence of sensation in a reconstructed breast has been shown to improve patient-related quality of life following mastectomy reconstruction and is an important safety factor for prevention of burns and other flap injuries. Unfortunately, women who have breast skin excised during mastectomy are reconstructed with a traditional DIEP flap that does not restore sensation to the skin.
Detailed description
The Deep Inferior Epigastric Perforator (DIEP) flap is the current standard of care in breast reconstruction. The DIEP flap does not normally have sensation restored. The presence of sensation in a reconstructed breast has been shown to improve patient-rated quality of life following mastectomy and reconstruction and is an important safety factor for prevention of burns and other flap injuries. Unfortunately, women who have breast skin excised during mastectomy are reconstructed with a traditional DIEP flap that does not restore sensation to the skin. As such, the investigators aim to perform a prospective randomized single-blinded trial to evaluate sensory return to DIEP flaps following nerve coaptation.
A blinded, prospective study will be performed involving Manitoban women over 18 years undergoing bilateral breast reconstruction with DIEP flaps. The women will have one breast reconstructed in the standard of care (DIEP flap with no nerve coaptation) and one breast reconstructed with both DIEP flap and sensory nerve coaptation; the side of coaptation will be randomized. Objective sensibility to the breast will be tested pre- and post-operatively (3, 6, 12 months) using the Pressure Specified Sensory Device (PSSD). Patients will also complete the Breast Q questionnaire postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIEP reconstruction, no neurotization | No intervention | –DIEP reconstruction No sensory neurotization |
| DIEP reconstruction, neurotization | Experimental | Procedure: Sensory neurotizationDIEP reconstruction With sensory neurotization |
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)
- female subjects older than 18
- scheduled for immediate bilateral breast reconstruction following bilateral non-nipple sparing mastectomy
- using DIEP free flap reconstruction
- with a large skin paddle
Key exclusion criteria (4 listed)
- pre-operative radiation or chemotherapy was performed
- post-operative radiation or chemotherapy is planned
- reconstruction is performed in a delayed fashion
- a nerve conduit is necessary for nerve coaptation
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 |
|---|---|---|
| Sensory neurotizationThe donor nerve is a cutaneous nerve that is identified with the most inferior lateral perforator vessels. The nerve is then dissected for neurotization and divided at the level of the fascia where it is a pure sensory nerve. The recipient intercostal nerve is usually easily identified in the third intercostal space during the dissection of the internal mammary artery and vein. The anterior branch of the third intercostal nerve can usually be found at the junction of the inferior portion of the third rib and the sternum, approximately 80% of the time. The nerve is dissected and transected medially. It is then mobilized to give it the longest length possible in preparation for neurotization. Neurotization is performed by coapting the donor nerve to the third anterior intercostal nerve directly with a 9-0 nylon suture in standard fashion. | Procedure or surgery | DIEP reconstruction, neurotization |
Primary outcome
Sensory recovery to neurotized DIEP flap
Time frame: 3 months post-operatively
Sensory recovery measured using Pressure Specified Sensory Device
Sensory recovery to neurotized DIEP flap
Time frame: 6 months post-operatively
Sensory recovery measured using Pressure Specified Sensory Device
Sensory recovery to neurotized DIEP flap
Time frame: 12 months post-operatively
Sensory recovery measured using Pressure Specified Sensory Device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- 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.
Rebecca Miller, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory neurotization in people with Sensitisation, run by University of Manitoba 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 4 Oct 2021. 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?
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?
Sensory recovery to neurotized DIEP flap (time frame: 3 months post-operatively). The study lists 3 primary outcomes in all. 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 4 Oct 2021.