immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement. for Mastectomy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mastectomy+1 More
immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement. - Procedure
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial is a comparative, multicenter, prospective, single-blinded study which will include 100 patients.

Eligible Conditions
  • Mastectomy
  • Breast Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 1 year

1 year
Number of Revisional surgeries
Rate of Capsular contracture
Rate of Explantation
24 hours
Postoperative Pain and 24-hour narcotic consumption
3 months
Rate of Wound
Rate of infection
Month 12
BREAST-Q© Post-operative
4 weeks
Mastectomy flap necrosis
Rate of seroma
Before Surgery
BREAST-Q© Pre-operative scale

Trial Safety

Trial Design

2 Treatment Groups

Subpectoral implant placement
1 of 2
Prepectoral implant placement
1 of 2
Active Control
Experimental Treatment

56 Total Participants · 2 Treatment Groups

Primary Treatment: immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement. · No Placebo Group · N/A

Prepectoral implant placement
Procedure
Experimental Group · 1 Intervention: immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement. · Intervention Types: Procedure
Subpectoral implant placement
Procedure
ActiveComparator Group · 1 Intervention: Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
528 Previous Clinical Trials
2,511,225 Total Patients Enrolled
Jing Zhang, MDPrincipal InvestigatorOttawa Hospital Research Institute
2 Previous Clinical Trials
550 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
All patients undergoing mastectomy for breast cancer or prophylaxis for breast cancer with immediate implant-based reconstruction.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: October 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.