Breast ReconstructionNCT05491473
Negative Pressure in PAP Donor Sites
An observational study of Breast Reconstruction, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
A retrospective chart review will be conducted to identify patients who received breast reconstruction using free profunda artery perforator (PAP) flap by the investigators from January 2015 to August 2021. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- Closed incisional negative pressure wound therapy (iNPWT) system
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Sep 2021to 31 May 2022
- 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: Patients who received immediate breast reconstruction using PAP flaps by the PI from November 2016 to August 2020.
Who may be able to join
- patients who underwent unilateral microsurgical breast reconstruction using PAP flaps from the PI (JJH) from November 2016 to August 2020
Who cannot join
- patients with delayed reconstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Closed Incision Negative Pressure Therapy in Transverse Donor Site Closure of Free Profunda Artery Perforator Flap for Breast Reconstruction
A retrospective chart review will be conducted to identify patients who received breast reconstruction using free profunda artery perforator (PAP) flap by the investigators from January 2015 to August 2021. The included patients will be grouped into two according to the application of incisional negative pressure wound therapy (NP) on the donor site. Patients' demographic data including their age at the surgery, body mass index (BMI), medical comorbidities including the hypertension and diabetes, and smoking history will be obtained from the retrospective chart review. Parameters of the flap will be carefully reviewed, including the flap harvested width, and flap harvested length, the flap harvested and used size, the size of the mastectomy, the ischemia time of the flap. The major interest is in the donor site management and patient's overall recovery. The complications of the donor site will be categorized into acute and chronic ones depending on the time of presence. Donor site complications, such as wound break down, hematoma, seroma, the total amount of the drainage will be recorded. The cutting time point for acute and chronic complications is 1 month. The total amount of drainage from the drainage tube inserted and the patients' off-bed time (day) will also be recorded. Besides, for patients with follow up time of more than 1 year, the scar will be evaluated using Vancouver scar scale.
Statistics Data will be analyzed using graphing and statistical analysis software SPSS 21 software (IBM, Chicago, Illinois, USA). Rank sum and independent t test will be applied to calculate continuous variables in demographic values, while Chi-square will be applied to calculate categorical variables such as postoperative complications. A probability of less than 0.05 will be considered significant.
Read more
Potential risks: No
Confidentiality:
All the patient identifiable information, which includes name, chart number and birthday, involved in the study will be strictly confidential.
- Conditions
- Breast Reconstruction
- Being tested
- Closed incisional negative pressure wound therapy (iNPWT) system
- Keywords
- breast reconstruction, profunda artery perforator flap, tensioned wound healing, negative pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed incisional negative pressure wound therapy (iNPWT) systemDevice
The closed incisional negative pressure wound therapy (iNPWT) system (PREVENA Incision Management System, KCI, an Acelity company, San Antonio, Texas, USA)
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients who did not receive the application of iNPWT at the donor site. | |
| Negative pressure | Patients who received the application of iNPWT at the donor site. Receives: Device: Closed incisional negative pressure wound therapy (iNPWT) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Off-bed time (days)
Measured: post-operative 14 days
Drainage amount (ml)
Measured: post-operative 14 days
Vacuum ball removed timing
Measured: post-operative 14 days
Vancouver Scar Scale (VSS)
Score range from 0-13, used to measure scar the scar appearance. The lower means a better outcome.
Measured: 1 year after surgery
Re-open
Whether the patient return to the operation room to check the blood flow or re-do the anastomosis.
Measured: post-operative 14 days
Donor site acute complication (< 30 days)
Measured: post-operative 30 days
Donor site chronic complication (> 30 days)
Measured: 1 year after surgery
Donor site revision
Whether the patient received scar revision surgery on the donor site where the tissue harvested for breast reconstruction.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start23 Sep 2021
- Primary completion10 Apr 2022
- Study completion31 May 2022
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.
- 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Ju Huang, Chang Gung Memorial Hospital
- Investigators
- Jung-Ju Huang, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491473
- Sponsor's protocol ID
- 202101649B0
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 8 Aug 2022
- Results posted
- 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 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed Incision Negative Pressure Therapy in Transverse Donor Site Closure of Free Profunda Artery Perforator Flap for Breast Reconstruction
- ClinicalTrials.gov ID
- NCT05491473
- Acronym / sponsor ID
- 202101649B0
- Conditions
- Breast Reconstruction
- Keywords
- breast reconstruction, profunda artery perforator flap, tensioned wound healing, negative pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 10 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 8 Aug 2022 (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.
A retrospective chart review will be conducted to identify patients who received breast reconstruction using free profunda artery perforator (PAP) flap by the investigators from January 2015 to August 2021. The included patients will be grouped into two according to the application of incisional negative pressure wound therapy (NP) on the donor site. Patients' demographic data including their age at the surgery, body mass index (BMI), medical comorbidities including the hypertension and diabetes, and smoking history will be obtained from the retrospective chart review. Parameters of the flap will be carefully reviewed, including the flap harvested width, and flap harvested length, the flap harvested and used size, the size of the mastectomy, the ischemia time of the flap. The major interest is in the donor site management and patient's overall recovery. The complications of the donor site will be categorized into acute and chronic ones depending on the time of presence. Donor site complications, such as wound break down, hematoma, seroma, the total amount of the drainage will be recorded. The cutting time point for acute and chronic complications is 1 month. The total amount of drainage from the drainage tube inserted and the patients' off-bed time (day) will also be recorded. Besides, for patients with follow up time of more than 1 year, the scar will be evaluated using Vancouver scar scale.
Statistics Data will be analyzed using graphing and statistical analysis software SPSS 21 software (IBM, Chicago, Illinois, USA). Rank sum and independent t test will be applied to calculate continuous variables in demographic values, while Chi-square will be applied to calculate categorical variables such as postoperative complications. A probability of less than 0.05 will be considered significant.
Potential risks: No
Confidentiality:
All the patient identifiable information, which includes name, chart number and birthday, involved in the study will be strictly confidential.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Patients who did not receive the application of iNPWT at the donor site. |
| Negative pressure | – | Device: Closed incisional negative pressure wound therapy (iNPWT) systemPatients who received the application of iNPWT at the donor site. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who received immediate breast reconstruction using PAP flaps by the PI from November 2016 to August 2020.
Key inclusion criteria (1 listed)
- patients who underwent unilateral microsurgical breast reconstruction using PAP flaps from the PI (JJH) from November 2016 to August 2020
Key exclusion criteria (1 listed)
- patients with delayed 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 |
|---|---|---|
| Closed incisional negative pressure wound therapy (iNPWT) systemThe closed incisional negative pressure wound therapy (iNPWT) system (PREVENA Incision Management System, KCI, an Acelity company, San Antonio, Texas, USA) | Device | Negative pressure |
Primary outcome
Off-bed time (days)
Time frame: post-operative 14 days
Drainage amount (ml)
Time frame: post-operative 14 days
Vacuum ball removed timing
Time frame: post-operative 14 days
Vancouver Scar Scale (VSS)
Time frame: 1 year after surgery
Score range from 0-13, used to measure scar the scar appearance. The lower means a better outcome.
Re-open
Time frame: post-operative 14 days
Whether the patient return to the operation room to check the blood flow or re-do the anastomosis.
Donor site acute complication (< 30 days)
Time frame: post-operative 30 days
Donor site chronic complication (> 30 days)
Time frame: 1 year after surgery
Donor site revision
Time frame: 1 year after surgery
Whether the patient received scar revision surgery on the donor site where the tissue harvested for breast reconstruction.
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 8 Aug 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.
Jung-Ju Huang, MD principal investigator
Chang Gung Memorial 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, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 8 Aug 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 Taiwan. 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?
Off-bed time (days) (time frame: post-operative 14 days). The study lists 8 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 8 Aug 2022; AzTrials last refreshed its copy on 30 Oct 2026.