Breast ReconstructionNCT02481284
Microcirculation of the Abdominal Skin After Deep Inferior Epigastric Artery Perforator Flap Procedure
An observational study of Breast Reconstruction and Skin Perfusion, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study was to perform a quantitative perfusion study of the undermined abdominal skin in deep inferior epigastric artery perforator flap breast reconstruction patients in order to obtain more knowledge on perfusion dynamics. Laser Doppler perfusion imaging (LDPI) was used to evaluate this. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Reconstruction, Skin Perfusion
- What is being tested?
- Laser Doppler perfusion imaging
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2008to Mar 2015
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 20 women consecutively undergoing secondary, unilateral breast reconstruction with a DIEAP flap were identified and recruited to participate in the study. The patients were informed about of risks and benefits and gave written consent prior to participation. All smokers stopped smoking 4 weeks prior to surgery.
Who may be able to join
- Secondary, unilateral breast reconstruction with a DIEAP
- All smokers stopped smoking 4 weeks prior to surgery
Who cannot join
- Metastatic disease
- Bilateral breast reconstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microcirculatory Evaluation of the Abdominal Skin in Breast Reconstruction With Deep Inferior Epigastric Artery Perforator Flap
The purpose of this study was to perform a quantitative perfusion study of the undermined abdominal skin in deep inferior epigastric artery perforator flap breast reconstruction patients in order to obtain more knowledge on perfusion dynamics. Laser Doppler perfusion imaging (LDPI) was used to evaluate this.
Microcirculatory changes were monitored in the abdominal skin of 20 consecutive patients. Measurements were taken and recorded within four standardized zones covering the skin between the xiphoid process and the upper incisional boundary of the flap (zone 1-4; cranial to caudal).
Read the detailed description
Background: No studies have assessed the perfusion of the undermined abdominal skin in breast reconstruction with deep inferior epigastric artery perforator flap. A greater understanding of the procedure's impact on the perfusion of the abdominal skin can be valuable in predicting areas susceptible to necrosis.
Methods: Microcirculatory changes were monitored in the abdominal skin of 20 consecutive patients undergoing breast reconstruction with a deep inferior epigastric artery perforator flap. Quantitative mapping was performed with laser Doppler perfusion imaging at seven set intervals. Measurements were taken and recorded within four standardized zones covering the skin between the xiphoid process and the upper incisional boundary of the flap (zone 1-4; cranial to caudal).
- Conditions
- Breast Reconstruction, Skin Perfusion
- Being tested
- Laser Doppler perfusion imaging
- Keywords
- Breast reconstruction, Deep inferior epigastric artery perforator flap, Skin perfusion, Plastic and reconstructive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Doppler perfusion imagingDevice
LDPI is an extension of laser Doppler flowmetry (LDF) and was developed to generate a colour-coded perfusion image in a large area of skin.
| Study group | Role | What they receive |
|---|---|---|
| Laser Doppler Perfusion Imaging | 20 consequetive cases undergoing breast reconstruction with Deep inferior epigastric artery perforator flap who had evaluation of the microcirculation of the abdominal skin with laser Doppler perfusion imaging Receives: Device: Laser Doppler perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion of the abdominal zones measured in mean perfusion units
Measured: Preoperative
Perfusion of the abdominal zones measured in mean perfusion units
Measured: two hours (After raising the flap)
Perfusion of the abdominal zones measured in mean perfusion units
Measured: Three hours (After undermining)
Perfusion of the abdominal zones measured in mean perfusion units
Measured: Five hours (After abdominal closure)
Perfusion of the abdominal zones measured in mean perfusion units
Measured: Postoperative day 1 (POD1)
Perfusion of the abdominal zones measured in mean perfusion units
Measured: Postoperative day 3 (POD3)
Perfusion of the abdominal zones measured in mean perfusion units
Measured: Postoperative day 7 (POD7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJan 2008
- Primary completionSep 2009
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Oslo 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Alexander Tønseth, Oslo University Hospital
- Investigators
- Kim A Tønseth, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481284
- Sponsor's protocol ID
- CAIngvaldsen
- Status last verified
- Jun 2015
- First submitted
- 11 May 2015
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculatory Evaluation of the Abdominal Skin in Breast Reconstruction With Deep Inferior Epigastric Artery Perforator Flap
- ClinicalTrials.gov ID
- NCT02481284
- Acronym / sponsor ID
- CAIngvaldsen
- Conditions
- Breast Reconstruction, Skin Perfusion
- Keywords
- Breast reconstruction, Deep inferior epigastric artery perforator flap, Skin perfusion, Plastic and reconstructive surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Jun 2015 (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 was to perform a quantitative perfusion study of the undermined abdominal skin in deep inferior epigastric artery perforator flap breast reconstruction patients in order to obtain more knowledge on perfusion dynamics. Laser Doppler perfusion imaging (LDPI) was used to evaluate this.
Microcirculatory changes were monitored in the abdominal skin of 20 consecutive patients. Measurements were taken and recorded within four standardized zones covering the skin between the xiphoid process and the upper incisional boundary of the flap (zone 1-4; cranial to caudal).
Detailed description
Background: No studies have assessed the perfusion of the undermined abdominal skin in breast reconstruction with deep inferior epigastric artery perforator flap. A greater understanding of the procedure's impact on the perfusion of the abdominal skin can be valuable in predicting areas susceptible to necrosis.
Methods: Microcirculatory changes were monitored in the abdominal skin of 20 consecutive patients undergoing breast reconstruction with a deep inferior epigastric artery perforator flap. Quantitative mapping was performed with laser Doppler perfusion imaging at seven set intervals. Measurements were taken and recorded within four standardized zones covering the skin between the xiphoid process and the upper incisional boundary of the flap (zone 1-4; cranial to caudal).
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser Doppler Perfusion Imaging | – | Device: Laser Doppler perfusion imaging20 consequetive cases undergoing breast reconstruction with Deep inferior epigastric artery perforator flap who had evaluation of the microcirculation of the abdominal skin with laser Doppler perfusion imaging |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 20 women consecutively undergoing secondary, unilateral breast reconstruction with a DIEAP flap were identified and recruited to participate in the study. The patients were informed about of risks and benefits and gave written consent prior to participation. All smokers stopped smoking 4 weeks prior to surgery.
Key inclusion criteria (2 listed)
- Secondary, unilateral breast reconstruction with a DIEAP
- All smokers stopped smoking 4 weeks prior to surgery
Key exclusion criteria (2 listed)
- Metastatic disease
- Bilateral breast reconstruction
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 |
|---|---|---|
| Laser Doppler perfusion imagingLDPI is an extension of laser Doppler flowmetry (LDF) and was developed to generate a colour-coded perfusion image in a large area of skin. | Device | Laser Doppler Perfusion Imaging |
Primary outcome
Perfusion of the abdominal zones measured in mean perfusion units
Time frame: Preoperative
Perfusion of the abdominal zones measured in mean perfusion units
Time frame: two hours (After raising the flap)
Perfusion of the abdominal zones measured in mean perfusion units
Time frame: Three hours (After undermining)
Perfusion of the abdominal zones measured in mean perfusion units
Time frame: Five hours (After abdominal closure)
Perfusion of the abdominal zones measured in mean perfusion units
Time frame: Postoperative day 1 (POD1)
Perfusion of the abdominal zones measured in mean perfusion units
Time frame: Postoperative day 3 (POD3)
Perfusion of the abdominal zones measured in mean perfusion units
Time frame: Postoperative day 7 (POD7)
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 25 Jun 2015.
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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.
Kim A Tønseth, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Reconstruction and Skin Perfusion, run by Oslo University Hospital at 1 site in Norway.
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 2 inclusion and 2 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 25 Jun 2015. 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 Norway. 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?
Perfusion of the abdominal zones measured in mean perfusion units (time frame: Preoperative). The study lists 7 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 25 Jun 2015.