Comparison of One-port and Two-port Tissue Expanders for Breast Reconstruction

Randomized Clinical Trial Comparing 1-Port and 2-Port Tissue Expanders for Breast Reconstruction

Appropriate patients undergoing going immediate breast reconstruction with tissue expanders following mastectomy will be randomized to receive one-port or two-ports tissue expanders. Their clinical course, complications, and outcome will be analyzed.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Allergen one-port tissue expander placement; Device: AlloX2 two-port tissue expander placement

Detailed Description

The goal of this study is to compare a traditional single port expander with a two-port expander for equivalency when used for breast reconstruction following mastectomy. Complication rates that will be tracked include seroma, mastectomy skin flap necrosis, infection, wound dehiscence, need for explantation of the expander. Management of seromas will be compared between the two groups. The investigators hypothesize that the AlloX2 expander will be as effective in achieving the final outcome of completion of the second stage of reconstruction with equal or improved complication rates.

Study Design A prospective 1:1 randomized, single center, open label study will compare the traditional 1- port tissue expander with the AlloX2 2-port expander placed during immediate tissue expander breast reconstruction. Due to the nature of the surgery, the study cannot be blinded. Patients will be followed until completion of expansion and exchange for the permanent implant which typically takes 2 to 3 months. Risks factors that have been previously identified to be associated with increased postoperative complications include smoking, obesity, breast size, diabetes, radiation therapy, and expander fill volume will be identified. The final outcome is completion of expansion and exchange to permanent implant.

Standard operative procedure and postoperative care will be done. Both groups will have the same two external drains placed which is standard operative procedure. Complications will be noted at each postoperative clinic visit and entered into a database. Complication rates will be compared between the two groups and associations with risk factors will be analyzed. There will be no cross-over into the other group in case of reconstructive failure. Treatment failures will be treated in the same fashion in the two groups.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University Of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• patient agrees to immediate tissue expander breast reconstruction
• a suitable patient for tissue expander reconstruction

Exclusion Criteria:

• not a surgical candidate for immediate breast reconstruction
• age less than 18
• patient declines tissue expander reconstruction
• patient anticipated to need radiation therapy postoperatively

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: one-port; intervention is placement of one-port tissue expander at time of reconstruction	Device: Allergen one-port tissue expander placement; patients will be randomized to receive a one port or two port tissue expander for breast reconstruction; Other Names: Allergen one-port tissue expander
Active Comparator: two-port; intervention is placement of two-port tissue expander at time of reconstruction	Device: AlloX2 two-port tissue expander placement; patients will be randomized to receive a one port or two port tissue expander for breast reconstruction; Other Names: AlloX2 two-port tissue expander

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant	The number of patients that are able to undergo replacement of the tissue expander between the two arms will be compared	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Required Additional Intervention	Number of participants requiring additional intervention following tissue expander placement will be compared between the two arms of the study	3 months

Collaborators and Investigators

• Sponsor: Lesley Wong
• Investigators: Principal Investigator: Lesley Wong, MD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): July 19, 2019
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: February 27, 2016
• First Submitted That Met QC Criteria: March 28, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 16-0064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO