Trial Outcomes & Findings for Feasibility Study of Meso BioMatrix Device for Breast Reconstruction (NCT NCT01823107)

NCT ID: NCT01823107

Last Updated: 2019-09-10

Results Overview

Investigators evaluated each subject and each reconstructed breast for the occurrence of an adverse event from the first stage of reconstruction through the final follow-up visit. A breast related adverse event was defined as any untoward medical occurrence related to a reconstructed breast.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2019-09-10

Participant Flow

Participant milestones

Measure	Meso BioMatrix Acellular Peritoneum Matrix All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.
Overall Study STARTED	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Meso BioMatrix Acellular Peritoneum Matrix All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Feasibility Study of Meso BioMatrix Device for Breast Reconstruction

Baseline characteristics by cohort

Measure	Meso BioMatrix Acellular Peritoneum Matrix n=25 Participants All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.
Age, Continuous	49.4 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants
Body Mass Index	25.0 kg/m^2 STANDARD_DEVIATION 3.9 • n=5 Participants

PRIMARY outcome

Timeframe: 18 months

Investigators evaluated each subject and each reconstructed breast for the occurrence of an adverse event from the first stage of reconstruction through the final follow-up visit. A breast related adverse event was defined as any untoward medical occurrence related to a reconstructed breast.

Outcome measures

Measure	Meso BioMatrix Acellular Peritoneum Matrix n=44 Reconstructed breasts All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.
Rate of Breast Related Adverse Events	12 Reconstructed breasts affected

SECONDARY outcome

Timeframe: 18 months (12 months after second stage reconstruction)

Subjects completed the reconstructive module of the BREAST-Q, a standardized instrument measuring patient satisfaction and health-related quality of life on a scale of 1 to 100, with higher scores indicating higher satisfaction. Completed Breast-Q questionnaires were scored according to the author's instructions. Aesthetic satisfaction was measured using the Breast-Q Satisfaction with Breasts subscale score.

Outcome measures

Measure	Meso BioMatrix Acellular Peritoneum Matrix n=24 Participants All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.
Measurement of Aesthetic Satisfaction With the Use of the Breast-Q Survey	71.2 score on a scale Standard Deviation 15.5

SECONDARY outcome

Timeframe: 18 months

Population: Forty-four (44) breasts were reconstructed among the 25 enrolled subjects. Reconstruction failure was evaluated on a per reconstructed breast basis.

Reconstruction failure was defined as a serious adverse event in a reconstructed breast resulting in unplanned removal of the prosthesis and/or Meso BioMatrix Acellular Peritoneum Matrix.

Outcome measures

Measure	Meso BioMatrix Acellular Peritoneum Matrix n=44 Reconstructed breasts All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.
Rate of Reconstruction Failure	3 Reconstructed breasts affected

Adverse Events

Meso BioMatrix Acellular Peritoneum Matrix

Serious events: 7 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Meso BioMatrix Acellular Peritoneum Matrix n=25 participants at risk All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.
Reproductive system and breast disorders Seroma	4.0% 1/25 • 18 months
General disorders Fever	4.0% 1/25 • 18 months
Reproductive system and breast disorders Wound dehiscence	16.0% 4/25 • 18 months
Blood and lymphatic system disorders Hematoma	4.0% 1/25 • 18 months
Reproductive system and breast disorders Skin flap necrosis	4.0% 1/25 • 18 months

Other adverse events

Measure	Meso BioMatrix Acellular Peritoneum Matrix n=25 participants at risk All subjects had the Meso BioMatrix Acellular Peritoneum Matrix implanted along with a tissue expander during the first stage of breast reconstruction. After tissue expansion, the tissue expander was replaced with a breast implant during the second stage of reconstruction.
Reproductive system and breast disorders Breast pain	12.0% 3/25 • 18 months
Skin and subcutaneous tissue disorders Skin rash	12.0% 3/25 • 18 months
Respiratory, thoracic and mediastinal disorders Erythema	16.0% 4/25 • 18 months

Additional Information

Forde Hansell

DSM Biomedical

Phone: 484-713-2152

Email: forde.hansell@dsm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place