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| Name | Class |
|---|---|
| ConvaTec Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAC group | Experimental | A randomized group of patients receiving negative pressure wound therapy dressing (Avelle-ConvaTec) on closed incision |
|
| ST group | Active Comparator | A randomized group of patients receiving standard dressing (sterile gauze and medical tape) on closed incision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Breast reconstruction | Procedure | immediate mastectomy with breast reconstruction with implants or expanders |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
female patients with indications for immediate breast reconstruction
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| Name | Affiliation | Role |
|---|---|---|
| Dawid Murawa, PROF | University in Zielona Gora | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University in Zielona Gora | Zielona Góra | Lubusz Voivodeship | 65-046 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30586097 | Result | 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. | |
| 27170231 | Result | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D016462 | Mammaplasty |
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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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 |
| 27536498 | Result | 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. |
| 30324063 | Result | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |