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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04808765
• Other study ID #: ZG01012019
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: March 2021
• Source: University in Zielona Góra
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 1, 2021
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Reconstruction
• Surgical Wound

Intervention

Procedure:
• Immediate Breast reconstruction
immediate mastectomy with breast reconstruction with implants or expanders

Locations

Country	Name	City	State
Poland	University in Zielona Gora	Zielona Gora	Lubuskie

Sponsors (2)

Lead Sponsor	Collaborator
University in Zielona Góra	ConvaTec Inc.

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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 — View 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. eCollecti — View 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.000000 — View 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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postsurgical complications - reported for 60 patients	surgical site complications	1 month
Primary	Postsurgical complications - reported for 60 patients	surgical site complications	1 year
Secondary	Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast	measure SST with Skin-Thermometer	1 week after surgery
Secondary	Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast	measure SST with Skin-Thermometer	1 month after surgery
Secondary	Objective examination of scar quality	measure skin elasticity with Cutometer	1 year after surgery
Secondary	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
Secondary	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