An observational study in Mastectomy, Breast Reconstruction and Closed-Incision Negative Pressure Therapy, sponsored by Chiayi Christian Hospital. Completed at 1 site in Taiwan. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Chiayi Christian Hospital · Observational
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.
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A retrospective comparative study was conducted on 253 patients (283 flaps) undergoing immediate DIEP flap reconstruction between 2012 and 2025.
- A retrospective comparative study was conducted on 253 patients (283 flaps) undergoing immediate DIEP flap reconstruction between 2012 and 2025.
Exclusion Criteria:
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.
Device: Closed-Incision Negative Pressure Wound Therapy (CiNPWT)
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.
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.
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.
Time frame: Within 30 days following surgery
Plan to share: No
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Chiayi Christian Hospital