Two-stage implant-based breast reconstruction is the most common reconstructive technique after mastectomy. It is associated with some implant specific complications such as capsular contracture. Capsular contracture is one of the most frequent long…
ID
Bron
Verkorte titel
Aandoening
Breast reconstruction; breast implants; capsular contracture
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
capsular contracture rate
Doel van het onderzoek
Two-stage implant-based breast reconstruction is the most common reconstructive technique after mastectomy. It is associated with some implant specific complications such as capsular contracture. Capsular contracture is one of the most frequent long-term complications which develops when the capsule surrounding the implant, which always develops as a result of a normal foreign body reaction, becomes constricted and tight, resulting in malposition of the implant, a firm and/or painful breast and deterioration of the aesthetic result, which may require reoperation. On average one out of every six implant breast reconstruction patients will develop a capsular contracture after 10 years. Much of the etiology is still unknown, but a relationship between the outer surface of the implant and the chance of developing capsular contracture has been suggested . For example, compared to smooth implants, textured implants have shown to result in lower capsular contracture rates. Based on the current literature, which comprises of retrospective cohort studies and case-series, we hypothesize that polyurethane-covered implants reduce or delay the development of capsular contracture compared to textured implants.
Onderzoeksopzet
Surgery - 2 weeks post-op - 6 months post-op - yearly from 1 year post-op until 10 years post-op.
Onderzoeksproduct en/of interventie
Patients in both cohorts will receive a two-stage implant-based breast reconstruction after mastectomy. In the second stage, the intervention cohort will receive a polyurethane covered silicone implant and the control cohort will receive a standard textured silicone implant.
Publiek
Xavier Harmeling
kamer Ee-15.89, Dr.Molewaterplein 40, 3015 GD Rotterdam
Rotterdam
The Netherlands
+31107043242
tipi@erasmusmc.nl
Wetenschappelijk
Xavier Harmeling
kamer Ee-15.89, Dr.Molewaterplein 40, 3015 GD Rotterdam
Rotterdam
The Netherlands
+31107043242
tipi@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Female
• Age of 18 years or older
• Mastectomy is performed
• Eligible for two-stage implant-based breast reconstruction in accordance with the Dutch national breast reconstruction guideline
• First step of two-stage implant-based breast reconstruction (placement of tissue expander) is successfully completed
• Able to understand the patient information sheet, to complete questionnaires and to provide written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Additional use of autologous tissues for the breast reconstruction
• The use of acellular dermal matrix or synthetic mesh
• Prior irradiation of the breast or an indication for postoperative radiotherapy
• Revision surgery or tertiary breast reconstruction
• Inflammatory carcinoma
• Evidence of distant metastases
• Active infection at the surgical field or distant locations
Opzet
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