Clinical trial NCT04808765: Closed Incision Disposable Negative Pressure Wound Therapy in Immediate Postmastectomy Breast Reconstruction
Official title: Experience and Comparison Between Closed Incision Disposable Negative Pressure Wound Therapy With Standard Care in Immediate Postmastectomy Breast Reconstruction - Prospective, Randomized and Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Breast Reconstruction
Keywords: breast cancer
closed incision negative pressure wound therapy
Breast Reconstruction
Lead sponsor: University in Zielona Góra
Sponsor class: OTHER
Collaborators: name: ConvaTec Inc.
First posted: 2021-03-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Postsurgical complications - reported for 60 patients
timeFrame: 1 month
measure: Postsurgical complications - reported for 60 patients
timeFrame: 1 year
Secondary outcomes:
measure: Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast
timeFrame: 1 week after surgery
measure: Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast
timeFrame: 1 month after surgery
measure: Objective examination of scar quality
timeFrame: 1 year after surgery
measure: Subjective examination of scar quality
timeFrame: 1 year after surgery
measure: Subjective quality of life
timeFrame: 1-2 years after surgery
Other outcomes:
Locations:
city: Zielona Gora
country: Poland
facility: University in Zielona Gora
state: Lubuskie
Study officials:
affiliation: University in Zielona Gora
name: Dawid Murawa, PROF
role: STUDY_CHAIR
References:
citation: Singh D, Lobach V, Holton T. Use of Closed-Incision Negative-Pressure Therapy in Aesthetic Surgery. Plast Reconstr Surg. 2019 Jan;143(1S Management of Surgical Incisions Utilizing Closed-Incision Negative-Pressure Therapy):11S-14S. doi: 10.1097/PRS.0000000000005306.
citation: Willy C, Agarwal A, Andersen CA, Santis G, Gabriel A, Grauhan O, Guerra OM, Lipsky BA, Malas MB, Mathiesen LL, Singh DP, Reddy VS. Closed incision negative pressure therapy: international multidisciplinary consensus recommendations. Int Wound J. 2017 Apr;14(2):385-398. doi: 10.1111/iwj.12612. Epub 2016 May 12.
citation: Gabriel A, Sigalove SR, Maxwell GP. Initial Experience Using Closed Incision Negative Pressure Therapy after Immediate Postmastectomy Breast Reconstruction. Plast Reconstr Surg Glob Open. 2016 Jul 22;4(7):e819. doi: 10.1097/GOX.0000000000000803. eCollection 2016 Jul.
citation: Gabriel A, Sigalove S, Sigalove N, Storm-Dickerson T, Rice J, Maxwell P, Griffin L. The Impact of Closed Incision Negative Pressure Therapy on Postoperative Breast Reconstruction Outcomes. Plast Reconstr Surg Glob Open. 2018 Aug 7;6(8):e1880. doi: 10.1097/GOX.0000000000001880. eCollection 2018 Aug.