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

NCT07546968 | Completed

• 1 other identifier: CYCH IRB.2020032
• Study Type: observational
• Target: 253
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastectomy; Breast Reconstruction; Closed-Incision Negative Pressure Therapy

Keywords

ciNPWT; Wound healing; DIEP flap; Microvascular safety

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 30 days following surgery

Study Arms (2)

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.

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.

Interventions

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.

CiNPWT Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A retrospective comparative study was conducted on 253 patients (283 flaps) undergoing immediate DIEP flap reconstruction between 2012 and 2025.

You may qualify if:

• \- A retrospective comparative study was conducted on 253 patients (283 flaps) undergoing immediate DIEP flap reconstruction between 2012 and 2025.

You may not qualify if:

• Age \<18

Sponsors & Collaborators

• Chiayi Christian Hospital: lead

Study Sites (1)

Ditmanson Medical Foundation Chiayi Christian Hospital

Chiayi City, 60002, Taiwan

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 23, 2026
• Study Start: September 6, 2012
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)