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OpenTrials
Completed

NCT Number: NCT07546968

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

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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Key information

Conditions

Mastectomy Breast Reconstruction Closed-Incision Negative Pressure Therapy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ditmanson Medical Foundation Chiayi Christian Hospital

Chiayi City, 60002, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Chiayi Christian Hospital

Other

Registry information

Official study title

Division of Plastic and Reconstruction Surgery

Important dates

Study start
2012
Primary completion
2025
Study completion
2025
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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