Breast Cancer Clinical Trial
— PreBRecOfficial title:
Prospective Multicentric Randomized Comparison of an Acellular Dermal Matrix Versus a Synthetic Mesh in Pre-pectoral Implant Based Breast Reconstruction
The rationale for present trial conception and design moves forward from the assumption that a subcutaneous, pre-pectoral reconstruction by means of soft tissue replacement devices is feasible, safe and giving rewarding results when compared to the standard retro-pectoral technique. Ahead of that, the trial aims to test if there is a difference in the outcomes between a biological and a synthetic material when placed as a support under the mastectomy skin flaps, both in terms of immediate complications and of long-term results.
Status | Not yet recruiting |
Enrollment | 86 |
Est. completion date | December 2020 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Inclusion criteria will entail cases of conservative mastectomies (skin-sparing mastectomy SSM, nipple-sparing mastectomy NSM and skin-reducing mastectomy SRM), both prophylactic and therapeutic. Included patients baseline characteristics will be: - age 18-80 years old - BMI between 18.5 and 35. - Former smokers (up until 3 weeks before surgery) - hypertension at oral medications - diabetes - previous breast surgery - previous breast and chest wall radiation therapy will be allowed. Exclusion Criteria: - T4 and metastatic breast cancers - obese patients (BMI over 35) - currently smoking patients (within 3 weeks before surgery) - refusal to sign the consent - severe comorbidities requiring a chronic therapy (renal failure, heart failure, cardiovascular diseases, pulmonary diseases, hepatic diseases, and metabolic diseases). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Breast Surgery Unit, Guy's and St Thomas' Hospital NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cost-efficiency analysis with comparison of cost in money of the two arms | Analysis of costs with comparison of the two arms will be carried out considering all costs from procedures and materials to possible late reinterventions to resolve complications and problems | at 3 years from mastectomy | No |
Other | Rate in percentage of complications in the sub-group of irradiated patients | An analysis of a specific subgroup of patients will be carried out, namely those previously submitted to a breast irradiation and those submitted to a post-mastectomy radiation therapy. Analysis of short-terms failures and long-term problems with change in reconstruction strategy will be considered. | at 3 years from mastectomy | Yes |
Primary | Rate in percentage of surgical complications | Surgical outcomes will be evaluated considering the rate in percentage of cases affected by the following complications among total number: surgical site infection (any infection requiring an antibiotic therapy, either oral or intravenous), wound dehiscence, seroma (any fluid collection requiring aspiration for more than a month from mastectomy), nipple/skin necrosis (either partial or complete), hematoma, red breast syndrome, with their reintervention rate. Rates will be compared between the two groups |
up to 6 months | Yes |
Primary | Rate in percentage of technique failure | The failure rate, as percentage, will be compared between the two arms: failure will be the prosthesis (implant or TE) loss rate (reintervention with prosthesis removal) among overall number of prostheses implanted. |
up to 6 months | Yes |
Secondary | Objective quality of life assessment with Baker scale for capsular contracture | Long-term outcomes, after two years from mastectomy and at least 3 months from TE/implant exchange, in quality of life will entail first of all an objective assessment: such evaluation will include the capsular contracture rate, with the assessment of the reintervention rate for amelioration or for a reconstructive strategy change. Among these objective evaluations, any possible short-term complications after second-stage procedure will be investigated. | at 2 years from mastectomy | No |
Secondary | Objective quality of life assessment with cosmetic evaluation on pictures with a Likert scale for scoring | A third party objective evaluation will be carried out by a group of a surgeon, a nurse and a lay person from a different center from that one where every single case was performed. This third party evaluation will assess the cosmetic outcome based on medical photographic files, giving a score for each patient. Scores from the two arms will be compared. | at 2 years from mastectomy | No |
Secondary | Subjective quality of life assessment with BREAST-Q questionnaire (Memorial Sloan-Kettering Cancer Center and The University of British Columbia © 2006, all rights reserved) | After 2 years from mastectomy and at least 3 months from TE/implant exchange a subjective evaluation will be carried out with BREAST-Q score (scores from the two arms will be transformed in 100 scale, summed and compared as median) | at 2 years from mastectomy | No |
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