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

Study Overview
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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.

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.

Official Title
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Experience and Comparison Between Closed Incision Disposable Negative Pressure Wound Therapy With Standard Care in Immediate Postmastectomy Breast Reconstruction - Prospective, Randomized and Controlled Study

Conditions
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Breast Cancer, Breast Reconstruction

Intervention / Treatment
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* Procedure: Immediate Breast reconstruction


Participation Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VAC group<br>A randomized group of patients receiving negative pressure wound therapy dressing (Avelle-ConvaTec) on closed incision | Procedure: Immediate Breast reconstruction<br>* immediate mastectomy with breast reconstruction with implants or expanders<br>* Other names: immediate mastectomy with breast reconstruction with implants or expanders;|
| Active Comparator: ST group<br>A randomized group of patients receiving standard dressing (sterile gauze and medical tape) on closed incision | Procedure: Immediate Breast reconstruction<br>* immediate mastectomy with breast reconstruction with implants or expanders<br>* Other names: immediate mastectomy with breast reconstruction with implants or expanders;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postsurgical complications - reported for 60 patients | surgical site complications | 1 month | 
| Postsurgical complications - reported for 60 patients | surgical site complications | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast | measure SST with Skin-Thermometer | 1 week after surgery | 
| Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast | measure SST with Skin-Thermometer | 1 month after surgery | 
| Objective examination of scar quality | measure skin elasticity with Cutometer | 1 year after surgery | 
| Subjective examination of scar quality | POSAS 2.0 (Patient and Observer Scar Assessment Scale) questionnaire for the observer and the patient. Questions regards painful, itchy scar, difference between scar and normal skin. The min score is 7, the max score is 70. The higher score means better result | 1 year after surgery | 
| Subjective quality of life | BREAST-Q reconstruction module and Breast implant illness survey for patients. Questions about self-confidence, comfort, acceptance of new appearance, feeling of implants, breast pain. The min score is 1, the max 3-5 depending on part of questionnaire | 1-2 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, closed incision negative pressure wound therapy, Breast Reconstruction