Clinical trial NCT02830685: Pre-pectoral Breast Reconstruction PART 1
Official title: Prospective Multicentric Randomized Comparison of an Acellular Dermal Matrix Versus a Synthetic Mesh in DIRECT-TO-IMPLANT (DTI) Pre-pectoral Implant Based Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: pre-pectoral breast reconstruction
subcutaneous breast reconstruction
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This phase III randomized clinical trial will compare direct-to-implant pre-pectoral breast reconstruction with different supportive materials:

the trial will comprise two arms: A-PRE-PECTORAL technique with a biological Acellular Dermal Matrix (ADM) prosthesis coverage and support + FAT GRAFTING VS B-PRE-PECTORAL technique with a synthetic Titanium Coated Polypropylene Mesh (TCPM) prosthesis coverage and support + FAT GRAFTING

Eligibility criteria: Inclusion Criteria:

Inclusion criteria will entail cases of conservative mastectomies (skin-sparing mastectomy SSM

* Nipple-sparing mastectomy NSM and skin-reducing mastectomy SRM)
* 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).

Primary outcomes:
measure: Rate in percentage of surgical complications
timeFrame: up to 6 months
measure: Rate in percentage of technique failure
timeFrame: up to 6 months
Secondary outcomes:
measure: Objective quality of life assessment with Baker scale for capsular contracture
timeFrame: at 2 years from mastectomy
measure: Objective quality of life assessment with cosmetic evaluation on pictures with a Likert scale scoring
timeFrame: at 2 years from mastectomy
measure: Subjective quality of life assessment using the BREAST-Q questionnaire (Memorial Sloan-Kettering Cancer Center and The University of British Columbia © 2006, all rights reserved).
timeFrame: at 2 years from mastectomy
Other outcomes:
measure: Cost-efficiency analysis with comparison of costs in money of the two different procedures and following possible adjunctive costs for reintervention in case of complications
timeFrame: at 3 years from mastectomy
measure: Rate in percentage of surgical complications in the sub-group of irradiated patients
timeFrame: at 3 years from mastectomy
Locations:
city: London
country: United Kingdom
facility: Breast Unit Surgery, Guy's and St Thomas' Hospital NHS Trust
Study officials:
References: