Blossom Tissue Expander for Breast Reconstruction

N/A

Waitlist Available

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patient pain will be assessed routinely (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until tissue expansion is complete (3 to 6 months).

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare a breast tissue expander that avoids frequent needle injections with conventional methods of breast reconstruction/augmentation.

Who is the study for?

This trial is for women over 18 who want a two-stage breast reconstruction or augmentation without active cancer, severe health issues, pregnancy, nursing status, age above 65, recent steroid use or connective tissue disorders. They must understand and sign the consent form in English.

What is being tested?

The study compares Blossom Smart Expander Technology with standard methods of expanding breast skin for reconstruction. The Blossom device aims to reduce discomfort by avoiding frequent saline injections through the skin.

What are the potential side effects?

While not explicitly stated here, potential side effects may include discomfort at the expansion site, infection risk from the device implantation process and possible allergic reactions to materials used in either expander.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ survey responses will be collected at standard post-operative time points (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until the second stage surgery (3 to 6 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~survey responses will be collected at standard post-operative time points (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until the second stage surgery (3 to 6 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and survey responses will be collected at standard post-operative time points (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until the second stage surgery (3 to 6 months). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of complications

Time until completion of tissue expansion

Secondary study objectives

Pain associated with tissue expansion

Patient satisfaction (BreastQ)

Patient satisfaction (device specific survey)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Blossom tissue expanderExperimental Treatment1 Intervention

The intervention group involves the placement of the Mentor Spectrum tissue expander coupled with Blossom Syringe Assist device inserted above the pectoralis major muscle in the usual fashion. The nature of the surgery remains identical to that employed for conventional breast tissue expander insertion for reconstruction or augmentation. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout will also take place until completion of the expansion, stabilization of surgical scars, and removal of all percutaneous drains. Tissue expansion will be automatic via the Blossom device until appropriate volume is achieved. Thereafter, follow-ups will be scheduled as needed (monthly) according to usual clinical practice in implant-based breast reconstruction in preparation for the second stage expander to definitive implant exchange.

Group II: Standard tissue expansionActive Control1 Intervention

The standard tissue expansion group will undergo the same procedure with placement of the Mentor Spectrum tissue expander inserted above the pectoralis major muscle in the usual fashion. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout will also take place until completion of the expansion, stabilization of surgical scars, and removal of all percutaneous drains. Tissue expansion will be achieved via serial injections of sterile saline into the tissue expander during postoperative follow up visits. Thereafter, follow-ups will be scheduled as needed (monthly) according to usual clinical practice in implant-based breast reconstruction in preparation for the second stage expander to definitive implant exchange. The postoperative follow-up and subsequent surgery to exchange the device to a permanent implant is normal part of standard care.

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