Breast Cancer, Breast Reconstruction
Conditions
Keywords
breast cancer, closed incision negative pressure wound therapy, Breast Reconstruction
Brief summary
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
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.
Interventions
PROCEDUREImmediate Breast reconstruction
immediate mastectomy with breast reconstruction with implants or expanders
Sponsors
ConvaTec Inc.
University in Zielona Góra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postsurgical complications - reported for 60 patients | 1 month | surgical site complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast | 1 week after surgery | measure SST with Skin-Thermometer |
| Objective examination of scar quality | 1 year after surgery | measure skin elasticity with Cutometer |
| Subjective examination of scar quality | 1 year after surgery | 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 |
| Subjective quality of life | 1-2 years after surgery | 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 |
Countries
Poland
Outcome results
None listed