No registrations found.
ID
Source
Brief title
Health condition
Breast reconstruction; breast implants; capsular contracture
Sponsors and support
Intervention
Outcome measures
Primary outcome
capsular contracture rate
Secondary outcome
revision surgery rates, complication rates, patient satisfaction and quality of life, user friendliness
Study objective
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.
Study design
Surgery - 2 weeks post-op - 6 months post-op - yearly from 1 year post-op until 10 years post-op.
Intervention
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.
Xavier Harmeling
kamer Ee-15.89, Dr.Molewaterplein 40, 3015 GD Rotterdam
Rotterdam
The Netherlands
+31107043242
tipi@erasmusmc.nl
Xavier Harmeling
kamer Ee-15.89, Dr.Molewaterplein 40, 3015 GD Rotterdam
Rotterdam
The Netherlands
+31107043242
tipi@erasmusmc.nl
Inclusion criteria
• 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
Exclusion criteria
• 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7067 |
NTR-old | NTR7265 |
Other | 63959 : ABR |