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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2021-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Breast Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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VAC group

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

Group Type EXPERIMENTAL

Immediate Breast reconstruction

Intervention Type PROCEDURE

immediate mastectomy with breast reconstruction with implants or expanders

ST group

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

Group Type ACTIVE_COMPARATOR

Immediate Breast reconstruction

Intervention Type PROCEDURE

immediate mastectomy with breast reconstruction with implants or expanders

Interventions

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Immediate Breast reconstruction

immediate mastectomy with breast reconstruction with implants or expanders

Intervention Type PROCEDURE

Other Intervention Names

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immediate mastectomy with breast reconstruction with implants or expanders

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No