BREAST ADM Trial for Alloplastic Breast Reconstruction

Not Applicable

Recruiting

• Conditions: Breast Reconstruction
• Interventions: Device: AlloDerm; Device: Flex HD; Device: AlloMax; Device: DermACELL

• Registration Number: NCT04661501
• Lead Sponsor: University of British Columbia

Brief Summary

This study is a randomized single blinded prospective clinical trial comparing the surgical outcomes of four different acellular dermal matrixes (ADMs) after primary breast reconstruction. ADMs are used in conjunction with tissue expanders or breast implants to reinforce the recreated breast pocket. Currently, 4 different ADMS are commercially available: AlloDerm, DermaCell, Allomax and Flex HD. It is unclear which ADM is clinically superior. The objective of the study is to compare the complications and post-op care of 4 different ADMs within a 2 year follow up to elucidate their surgical outcomes.

Detailed Description

This study is a randomized control trial and will include all patients who are agreeable and deemed appropriate for alloplastic breast reconstruction involving the use of an ADM with two stage tissue expander (TE) reconstruction. The ADMs used will be determined by random assignment to one of four available products being utilized within the study: AlloDerm, AlloMax, DermACELL and FlexHD. Each ADM product will comprise of an individual treatment arm. Participants undergoing bilateral reconstruction will have the same ADM used in each side. The four treatment arms will be compared to assess their impact on our primary outcome: proportion of clinically significant post-operative seroma requiring intervention. Analysis will be performed per surgeon to prevent post-operative outcomes from being confounded by the principle operator. The trial will initially be conducted as an internal pilot study. The study will initially target a study population of 40 patients for recruitment as a means to assess the feasibility of the study. In doing this, the pilot study will be able to establish the necessary protocol and administrative infrastructure that is needed to complete the trial in its entirety. This create a sample population for initial outcomes.

Study Timeline

• Study First Submitted: 2020-10-23
• Study Start: 2020-11-25
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 328

Inclusion Criteria

• All woman aged 21 years or older but less that 65 undergoing unilateral or bilateral mastectomy with alloplastic breast reconstruction using ADM.
• Breast reconstruction must be done by means of a two staged process using tissue expanders and ADM based reconstruction followed by implant tissue expander to implant exchange.

Exclusion Criteria

• Patients undergoing autologous reconstruction either at the time of mastectomy or in a delayed fashion.

• Patients with a history of previous breast reconstruction procedures.

• Patients with prior radiation treatment to the breast or with prior mantle radiation

• Any patient with a contraindication to breast reconstruction

• Patients undergoing an axillary node dissection with clearance

• Patients with an allergy to Polysporin or any of its ingredients.

• Patients with contraindications to any of the acellular dermal matrices:

  • DermACELL: Allergy to Gentamicin, Vancomycin[12]

• The surgeon performing the breast reconstruction may also deem a patient ineligible if intraoperatively, there is evidence of significant mastectomy flap ischemia prior to the initiation of the breast reconstruction procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AlloDerm group	AlloDerm	Device for immediate implant based breast reconstruction.
Flex HD group	Flex HD	Device for immediate implant based breast reconstruction.
AlloMax group	AlloMax	Device for immediate implant based breast reconstruction.
DermACELL group	DermACELL	Device for immediate implant based breast reconstruction.

Primary Outcome Measures

Name	Time	Method
Seroma incidence	Within 6 months of stage I or stage II surgery	Incidence of seroma formation requiring intervention including aspiration in-office or ultrasound-guided drainage

Secondary Outcome Measures

Name	Time	Method
Mean aspirations per seroma	Within 6 months of stage I or stage II surgery	Number of aspirations required for seroma resolution
Mean drain duration (Days)	Within 1 month of stage I or stage II surgery	Postoperative duration of drain placements
Hematoma incidence	Within 1 month of stage I or stage II surgery	Incidence of hematoma requiring evacuation or aspiration
ADM integration assessment	Within 1 month of stage II procedure	Clinical assessment of ADM integration into the breast pocket at the time of the second stage procedure.
Number of Participants with Implant loss	Within 2 year of stage II surgery	Loss of Implant for any reason (wound dehiscence, exposure, periprosthetic infection)
Number of Participants with Unplanned surgical care	Within 2 year of stage I or stage II surgery	Unexpected return to the operating room that was not planned at the initial visit for any reason
Mean drain output (ml)	Within 1 month of stage I or stage II surgery	Total volume of drain output until drain removal
Mean seroma volume (ml)	Within 6 months of stage I or stage II surgery	Total volume of seroma fluid aspirated until resolution of seroma
Surgical site infection incidence	Within 6 months of stage I or stage II surgery	Incidence of surgical site infection requiring antibiotics or operative management
Number of Participants with Mastectomy flap necrosis	Within 1 month of stage I surgery	Mastectomy flap necrosis and associated management: expectant, office debridement, or return to the operating room
Pre and post-operative satisfaction assessed using BREAST-Q	Within 2 years of stage II surgery	Evaluation of the satisfaction and quality of life of patients undergoing breast surgery using the BREAST-Q. Breast-Q is based on Breast Cancer Core Scale ranging from 0 to 100. Higher score means better outcome.
Number of Participants with Red breast syndrome	Within 1 month of stage I surgery	Noninfectious erythema localized to the area of ADM reconstruction
Capsular contracture incidence	Within 1 year of stage II surgery	Incidence of capsular contracture (as identified by the plastic surgeon, grouped by Baker's classification of severity)
Post-operative aesthetic assessment (patient and surgeon)	Within 2 years of stage II surgery	Subjective assessment of cosmetic outcome by the patient and blinded assessors using post-operative aesthetic breast survey assessment

Trial Locations

Locations (4)

UBC Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Saint Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Mount Saint Joseph's Hospital; 🇨🇦 Vancouver, British Columbia, Canada