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CiNPWT Using in Mastectomy Wound Care After DIEP Flaps for Breast Reconstruction

Division of Plastic and Reconstruction Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07546968
Enrollment
253
Registered
2026-04-23
Start date
2012-09-06
Completion date
2025-12-31
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Reconstruction, Closed-Incision Negative Pressure Therapy, Mastectomy

Keywords

ciNPWT, Wound healing, DIEP flap, Microvascular safety

Brief 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. 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.

Interventions

DEVICEClosed-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.

Sponsors

Chiayi Christian Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of surgical site complicationsWithin 30 days following surgeryFlap 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026