CiNPWT Using in Mastectomy Wound Care After DIEP Flaps for Breast Reconstruction
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Chiayi City, Taiwan, 60002
- Ditmanson Medical Foundation Chiayi Christian Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- A retrospective comparative study was conducted on 253 patients (283 flaps) undergoing immediate DIEP flap reconstruction between 2012 and 2025.
Exclusion Criteria:
- Age <18
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within 30 days following surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CYCH IRB.2020032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.