Biological Matrices Versus Synthetic Meshes
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospitals of Derby and Burton NHS Foundation Trust
About this trial
In this feasibility study, 60 women undergoing reconstruction will be randomly allocated to receive biological or synthetic mesh and followed for 6 months. The findings will tell us if patients and surgeons are comfortable with not being able to choose which mesh is used for the operation. In the larger surgical study, the investigators plan to measure patients' satisfaction with the reconstruction, patients' quality of life, complications from the operation and costs over 5 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
One-stage immediate breast reconstruction
Procedure/SurgeryOne-stage mesh assisted implant breast reconstruction
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Biological MatrixActive comparator 1 intervention
Group B: Synthetic MeshExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinician acceptance
Proportion of eligible women offered the trial
Time frame
2 years2
Patient acceptance
Proportion of women offered the trial who participate in the trial
Time frame
2 years3
Recruitment rate
Number of patient recruited per year per site
Time frame
2 years4
Compliance with allocated intervention
Number of patients not complying with randomisation allocation
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov