MastectomyNCT07546968
CiNPWT Using in Mastectomy Wound Care After DIEP Flaps for Breast Reconstruction
An observational study of Mastectomy and Breast Reconstruction, run by Chiayi Christian Hospital at 1 site in Taiwan.
Trial summary
Background: Closed-incision negative pressure wound therapy (ciNPWT) is effective in reducing postoperative complications, yet its use in free flap breast reconstruction mastectomy wound remains controversial due to concerns that external pressure may compromise the microvascular pedicle. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy, Breast Reconstruction, Closed-Incision Negative Pressure Therapy
- What is being tested?
- Closed-Incision Negative Pressure Wound Therapy (CiNPWT)
- Type of treatment
- Medical device
- How many people
- 253 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Sep 2012to 31 Dec 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: A retrospective comparative study was conducted on 253 patients (283 flaps) undergoing immediate DIEP flap reconstruction between 2012 and 2025.
Who may be able to join
- A retrospective comparative study was conducted on 253 patients (283 flaps) undergoing immediate DIEP flap reconstruction between 2012 and 2025.
Who cannot join
- Age <18
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Ditmanson Medical Foundation Chiayi Christian Hospital
Chiayi City, 60002
About this study
Official title: Division of Plastic and Reconstruction Surgery
Background: Closed-incision negative pressure wound therapy (ciNPWT) is effective in reducing postoperative complications, yet its use in free flap breast reconstruction mastectomy wound remains controversial due to concerns that external pressure may compromise the microvascular pedicle.
Methods: A retrospective comparative study was conducted on 253 patients (283 flaps) undergoing immediate DIEP flap reconstruction between 2012 and 2025. Patients were stratified into a ciNPWT group and a conventional dressing group. Outcomes included flap survival, wound complications, healing time, and length of stay (LOS). Multivariable regression models adjusted for confounders, including BMI and neoadjuvant chemotherapy.
- Being tested
- Closed-Incision Negative Pressure Wound Therapy (CiNPWT)
- Keywords
- ciNPWT, Wound healing, DIEP flap, Microvascular safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-Incision Negative Pressure Wound Therapy (CiNPWT)Device
Application of a negative pressure wound therapy system over primarily closed surgical incisions to reduce surgical site complications, including infection, seroma formation, wound dehiscence, and delayed wound healing.
| Study group | Role | What they receive |
|---|---|---|
| CiNPWT Cohort | This retrospective cohort includes patients who underwent mastectomy followed by immediate breast reconstruction with deep inferior epigastric perforator (DIEP) flap and received closed-incision negative pressure wound therapy (CiNPWT) applied to the mastectomy incision and/or abdominal donor site as part of postoperative wound management. Receives: Device: Closed-Incision Negative Pressure Wound Therapy (CiNPWT) | |
| Conventional Wound Dressing | This retrospective cohort includes patients who underwent mastectomy followed by immediate breast reconstruction with DIEP flap and received conventional postoperative wound dressing according to institutional standard wound care protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical site complications
Flap survival rate(%), wound complications rate(%), healing time (minute), and length of stay (LOS)(days). Multivariable regression models adjusted for confounders, including BMI 【Body Mass Index ,body weight(kg)/height(m)/height(m)】and neoadjuvant chemotherapy.
Measured: Within 30 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start6 Sep 2012
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546968
- Sponsor's protocol ID
- CYCH IRB.2020032
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 23 Apr 2026
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Division of Plastic and Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT07546968
- Acronym / sponsor ID
- CYCH IRB.2020032
- Keywords
- ciNPWT, Wound healing, DIEP flap, Microvascular safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Study start
- 6 Sep 2012 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 23 Apr 2026 (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.
Background: Closed-incision negative pressure wound therapy (ciNPWT) is effective in reducing postoperative complications, yet its use in free flap breast reconstruction mastectomy wound remains controversial due to concerns that external pressure may compromise the microvascular pedicle.
Methods: A retrospective comparative study was conducted on 253 patients (283 flaps) undergoing immediate DIEP flap reconstruction between 2012 and 2025. Patients were stratified into a ciNPWT group and a conventional dressing group. Outcomes included flap survival, wound complications, healing time, and length of stay (LOS). Multivariable regression models adjusted for confounders, including BMI and neoadjuvant chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CiNPWT Cohort | – | Device: Closed-Incision Negative Pressure Wound Therapy (CiNPWT)This retrospective cohort includes patients who underwent mastectomy followed by immediate breast reconstruction with deep inferior epigastric perforator (DIEP) flap and received closed-incision negative pressure wound therapy (CiNPWT) applied to the mastectomy incision and/or abdominal donor site as part of postoperative wound management. |
| Conventional Wound Dressing | – | –This retrospective cohort includes patients who underwent mastectomy followed by immediate breast reconstruction with DIEP flap and received conventional postoperative wound dressing according to institutional standard wound care protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective comparative study was conducted on 253 patients (283 flaps) undergoing immediate DIEP flap reconstruction between 2012 and 2025.
Key inclusion criteria (1 listed)
- A retrospective comparative study was conducted on 253 patients (283 flaps) undergoing immediate DIEP flap reconstruction between 2012 and 2025.
Key exclusion criteria (1 listed)
- Age <18
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-Incision Negative Pressure Wound Therapy (CiNPWT)Application of a negative pressure wound therapy system over primarily closed surgical incisions to reduce surgical site complications, including infection, seroma formation, wound dehiscence, and delayed wound healing. | Device | CiNPWT Cohort |
Primary outcome
Incidence of surgical site complications
Time frame: Within 30 days following surgery
Flap survival rate(%), wound complications rate(%), healing time (minute), and length of stay (LOS)(days). Multivariable regression models adjusted for confounders, including BMI 【Body Mass Index ,body weight(kg)/height(m)/height(m)】and neoadjuvant chemotherapy.
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 23 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mastectomy and Breast Reconstruction, run by Chiayi Christian 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 23 Apr 2026. 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?
Incidence of surgical site complications (time frame: Within 30 days following 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 23 Apr 2026.