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

Primary Purpose

Breast Cancer, Breast Reconstruction

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Immediate Breast reconstruction
Sponsored by
University in Zielona Góra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer, closed incision negative pressure wound therapy, Breast Reconstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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;

Sites / Locations

  • University in Zielona Gora

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VAC group

ST group

Arm Description

A randomized group of patients receiving negative pressure wound therapy dressing (Avelle-ConvaTec) on closed incision

A randomized group of patients receiving standard dressing (sterile gauze and medical tape) on closed incision

Outcomes

Primary Outcome Measures

Postsurgical complications - reported for 60 patients
surgical site complications
Postsurgical complications - reported for 60 patients
surgical site complications

Secondary Outcome Measures

Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast
measure SST with Skin-Thermometer
Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast
measure SST with Skin-Thermometer
Objective examination of scar quality
measure skin elasticity with Cutometer
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
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

Full Information

First Posted
March 17, 2021
Last Updated
March 21, 2021
Sponsor
University in Zielona Góra
Collaborators
ConvaTec Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04808765
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University in Zielona Góra
Collaborators
ConvaTec Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Reconstruction
Keywords
breast cancer, closed incision negative pressure wound therapy, Breast Reconstruction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VAC group
Arm Type
Experimental
Arm Description
A randomized group of patients receiving negative pressure wound therapy dressing (Avelle-ConvaTec) on closed incision
Arm Title
ST group
Arm Type
Active Comparator
Arm Description
A randomized group of patients receiving standard dressing (sterile gauze and medical tape) on closed incision
Intervention Type
Procedure
Intervention Name(s)
Immediate Breast reconstruction
Other Intervention Name(s)
immediate mastectomy with breast reconstruction with implants or expanders
Intervention Description
immediate mastectomy with breast reconstruction with implants or expanders
Primary Outcome Measure Information:
Title
Postsurgical complications - reported for 60 patients
Description
surgical site complications
Time Frame
1 month
Title
Postsurgical complications - reported for 60 patients
Description
surgical site complications
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast
Description
measure SST with Skin-Thermometer
Time Frame
1 week after surgery
Title
Superficial Skin Temperature (SST) of scar, skin next to scar and the second breast
Description
measure SST with Skin-Thermometer
Time Frame
1 month after surgery
Title
Objective examination of scar quality
Description
measure skin elasticity with Cutometer
Time Frame
1 year after surgery
Title
Subjective examination of scar quality
Description
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
Time Frame
1 year after surgery
Title
Subjective quality of life
Description
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
Time Frame
1-2 years after surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female patients with indications for immediate breast reconstruction
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawid Murawa, PROF
Organizational Affiliation
University in Zielona Gora
Official's Role
Study Chair
Facility Information:
Facility Name
University in Zielona Gora
City
Zielona Gora
State/Province
Lubuskie
ZIP/Postal Code
65-046
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30586097
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.
Results Reference
result
PubMed Identifier
27170231
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.
Results Reference
result
PubMed Identifier
27536498
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.
Results Reference
result
PubMed Identifier
30324063
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.
Results Reference
result

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

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