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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
immediate mastectomy with breast reconstruction with implants or expanders
University in Zielona Gora
Zielona Góra, Lubusz Voivodeship, Poland
Postsurgical complications - reported for 60 patients
surgical site complications
Time frame: 1 month
Postsurgical complications - reported for 60 patients
surgical site complications
Time frame: 1 year
Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast
measure SST with Skin-Thermometer
Time frame: 1 week after surgery
Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast
measure SST with Skin-Thermometer
Time frame: 1 month after surgery
Objective examination of scar quality
measure skin elasticity with Cutometer
Time frame: 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
Time frame: 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
Time frame: 1-2 years after surgery
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