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

Experience and Comparison Between Closed Incision Disposable Negative Pressure Wound Therapy With Standard Care in Immediate Postmastectomy Breast Reconstruction - Prospective, Randomized and Controlled Study

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Breast Reconstruction
• Intervention / Treatment: Procedure: Immediate Breast reconstruction

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Lubuskie
    • Zielona Gora, Lubuskie, Poland, 65-046
      • University in Zielona Gora

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VAC group; A randomized group of patients receiving negative pressure wound therapy dressing (Avelle-ConvaTec) on closed incision	Procedure: Immediate Breast reconstruction; immediate mastectomy with breast reconstruction with implants or expanders; Other Names: immediate mastectomy with breast reconstruction with implants or expanders
Active Comparator: ST group; A randomized group of patients receiving standard dressing (sterile gauze and medical tape) on closed incision	Procedure: Immediate Breast reconstruction; immediate mastectomy with breast reconstruction with implants or expanders; Other Names: immediate mastectomy with breast reconstruction with implants or expanders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postsurgical complications - reported for 60 patients	surgical site complications	1 month
Postsurgical complications - reported for 60 patients	surgical site complications	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast	measure SST with Skin-Thermometer	1 week after surgery
Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast	measure SST with Skin-Thermometer	1 month after surgery
Objective examination of scar quality	measure skin elasticity with Cutometer	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	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	1-2 years after surgery

Collaborators and Investigators

• Sponsor: University in Zielona Góra
• Collaborators: ConvaTec Inc.
• Investigators: Study Chair: Dawid Murawa, PROF, University in Zielona Gora

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 1, 2019
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 21, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: breast cancer; Breast Reconstruction; closed incision negative pressure wound therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: ZG01012019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No