Pre-pectoral Tissue Expander and Acellular Dermal Matrix... | NCT06374628

Studies
Pre-pectoral Tissue Expander and Acellular Dermal Matrix for a Two-stage Muscle Sparing Breast Reconstruction

NCT06374628

Sponsor

Rossella Elia, MD PhD

Status

Unknown status

Last Update Posted

Apr 18, 2024Actual

Enrollment

44Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

breast reconstruction

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2019Actual

Primary Completion Date

Apr 1, 2024Actual

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Apr 4, 2024

First Submission Date that Met QC Criteria

Apr 16, 2024

First Posted Date

Apr 18, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2024

Last Update Posted Date

Apr 18, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rossella Elia, MD PhD, Full time researcher, Unit of Plastic and Reconstructive Surgery, Policlinico of Bari, University of BariSponsor-Investigator

Lead Sponsor

Rossella Elia, MD PhDOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the research is to evaluate clinical outcomes of a two stage muscle sparing prepectoral breast reconstruction using tissue expander (TE) entirely covered by an ADM. The authors aim to report surgical indications, technical tips, clinical and histological outcomes with the final objective of delineate a decision-making algorithm for immediate prosthetic breast reconstruction.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
breast reconstruction	Procedure	breast reconstruction in two-stages using tissue expander entirely wrapped by acellular dermal matrix

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient satisfaction	Patients satisfaction will be evaluated through BREAST-Q questionnaire. the results from the questionnaire will be converted into a 0-100 scale with higher values meaning a better outcome	24 months of follow-up

Secondary Outcomes

Measure	Description	Time Frame
Pain Evaluation	Pain will be assessed trough Visual Analogic Scale (from minimum 0 to maximum 10). Higher values mean worse outcome	24 months of follow-up

Other Outcomes

Measure	Description	Time Frame
Complication rate	Complication will be recorded and classified with Clavien-Dindo Classification	24 months of follow-up

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

unilateral or bilateral mastectomy followed by two stage breast reconstruction with subcutaneous tissue expander and Acellular Dermal Matrix (ADM)
risk-reducing mastectomies followed by two stage breast reconstruction with subcutaneous tissue expander and ADM

Exclusion Criteria:

partial or total submuscular tissue expander placement,
tissue expander placement in conjunction with latissimus dorsi muscle flap or without ADM, -delayed reconstructions
previous breast surgery

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

consecutive patients who undergo two stage breast recontrustion with tissue expander and ADM

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
rossella elia	Contact	+393409616476		rossellaelia4@gmail.com
michele maruccia	Contact			marucciam@gmail.com

Overall Officials

Name	Affiliation	Role
Giuseppe Giudice	University of Bari	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Policlinico	Recruiting	Bari	BA		Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016462	Mammaplasty

Ancestor Terms

ID	Term
D003357	Cosmetic Techniques
D013812	Therapeutics
D019651	Plastic Surgery Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided