Closed Incision Disposable Negative Pressure Wound Therapy in Immediate Postmastectomy Breast Reconstruction

University in Zielona Góra

Status: Unknown

Conditions: Breast Reconstruction; Breast Cancer

Treatments: Procedure: Immediate Breast reconstruction

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04808765

ZG01012019

Details and patient eligibility

About

The study aimed to assess the impact of the use of closed incision negative pressure wound therapy (ciNPWT) after immediate breast reconstruction on the number of surgical-site complications, skin surface temperature, objective elastic and viscoelastic and subjective scar's quality to determine risk factors that could be considered as indications for prophylactic ciNPWT application.

Full description

Breast cancer excluding skin cancer is the most commonly diagnosed cancer after lung cancer among women. In recent years, the incidence rate of breast cancer has been rising by 0,3% annually. Screening tests are designed to diagnose breast cancer in possible early stadium of disease. Rapid diagnosis and efficacy of neoadjuvant and adjuvant therapies influence on immediate breast reconstructions after skin (SSM) and nipple-sparing mastectomies (NSM). The prophylactic methods of reducing a higher wound healing complication rate after neoadjuvant and adjuvant therapies are crucial.

The study aimed to assess the impact of the use of closed incision negative pressure wound therapy (ciNPWT) after immediate breast reconstruction on the number of surgical-site complications, skin surface temperature, objective elastic and viscoelastic and subjective scar's quality to determine risk factors that could be considered as indications for prophylactic ciNPWT application.

The analysis included data from anamnesis, details of performed surgical procedure, measurements of skin surface temperature with Skin-Thermometer® probe, measurements of skin elasticity with Cutometer® probe, and scar assessments according to POSAS v2.0 questionnaire for patient and observer.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >= 18 years of age
• indications for immediate breast reconstruction

Exclusion criteria

• pregnancy or lactation,
• use of steroids, use of immune modulators known to affect wound healing;
• tattoos in the area of the incision;
• breast skin conditions such as cutis laxa;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

VAC group

Experimental group

Description:

A randomized group of patients receiving negative pressure wound therapy dressing (Avelle-ConvaTec) on closed incision

Treatment:

Procedure: Immediate Breast reconstruction

ST group

Active Comparator group

Description:

A randomized group of patients receiving standard dressing (sterile gauze and medical tape) on closed incision

Treatment:

Procedure: Immediate Breast reconstruction