Closed Incision Disposable Negative Pressure Wound Therapy in Immediate Postmastectomy Breast Reconstruction
- Conditions
- Breast ReconstructionBreast Cancer
- Interventions
- Procedure: Immediate Breast reconstruction
- Registration Number
- NCT04808765
- Lead Sponsor
- University in Zielona Góra
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 60
- >= 18 years of age
- indications for immediate breast reconstruction
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ST group Immediate Breast reconstruction A randomized group of patients receiving standard dressing (sterile gauze and medical tape) on closed incision VAC group Immediate Breast reconstruction A randomized group of patients receiving negative pressure wound therapy dressing (Avelle-ConvaTec) on closed incision
- Primary Outcome Measures
Name Time Method Postsurgical complications - reported for 60 patients 1 year surgical site complications
- Secondary Outcome Measures
Name Time Method 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 resultObjective examination of scar quality 1 year after surgery measure skin elasticity with Cutometer
Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast 1 month after surgery measure SST with Skin-Thermometer
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
Trial Locations
- Locations (1)
University in Zielona Gora
🇵🇱Zielona Gora, Lubuskie, Poland