APPeaR

• Research type

  Research Study

• Full title

  A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis in Breast Reconstruction (APPeaR)

• IRAS ID

  261001

• Contact name

  Theresa Thomas

• Contact email

  ththomas@rtix.com

• Sponsor organisation

  RTI Surgical Inc.

• Clinicaltrials.gov Identifier

  NCT03744013

• Duration of Study in the UK

  2 years, 8 months, 31 days

• Research summary

  Research Summary:
  This is a post market prospective, multi-center study of up to 100 subjects (50 Fortiva® 1mm perforated and 50 Fortiva® 1mm non-perforated) at up to 10 clinical study sites in Europe. The primary objective of the study is to evaluate safety of the Fortiva® Tissue Matrix. Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events.
  The secondary objective of the study is to evaluate performance of the Fortiva® Tissue Matrix. Performance will be assessed by obtaining subject’s perception of the outcomes using the Breast-Q– Reconstruction survey. Subject’s participating in this study will be candidates for immediate post mastectomy reconstruction recruited from the participating investigator’s patient population.

  Lay summary of study results:
  The Fortiva® Tissue Matrix 1mm (perforated and non-perforated) were implanted in 87 subjects with data collected through 24 months post procedure. The mean age was 46 years of age with the majority of subjects receiving a single stage breast reconstruction (93.1%). The majority of the procedures were performed epipectoral (91.7% of breasts) and with silicone breast implants (91.0% of breasts) A total of one hundred and thirty-two adverse events were reported with almost half occurring within the first 30 days post procedure (47.7%). Seroma was the most common adverse event reported which is a known complication following breast reconstruction. Patient reported outcomes were collected and the Breast Q physical well-being showed an increase in score over baseline at all the follow-up visits. Reintervention requiring the repositioning of existing Fortiva® 1mm Tissue Matrix (perforated and non-perforated) were completed in four interventions.

• REC name

  North West - Greater Manchester West Research Ethics Committee

• REC reference

  19/NW/0281

• Date of REC Opinion

  21 Jun 2019

• REC opinion

  Further Information Favourable Opinion