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

NCT ID: NCT02725801

Last Updated: 2020-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2020-04-01

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

one-port

intervention is placement of one-port tissue expander at time of reconstruction

Group Type: ACTIVE_COMPARATOR

Allergen one-port tissue expander placement

Intervention Type: DEVICE

patients will be randomized to receive a one port or two port tissue expander for breast reconstruction

two-port

intervention is placement of two-port tissue expander at time of reconstruction

Group Type: ACTIVE_COMPARATOR

AlloX2 two-port tissue expander placement

Intervention Type: DEVICE

patients will be randomized to receive a one port or two port tissue expander for breast reconstruction

Interventions

Allergen one-port tissue expander placement

patients will be randomized to receive a one port or two port tissue expander for breast reconstruction

Intervention Type: DEVICE

AlloX2 two-port tissue expander placement

patients will be randomized to receive a one port or two port tissue expander for breast reconstruction

Intervention Type: DEVICE

Other Intervention Names

Allergen one-port tissue expander; AlloX2 two-port tissue expander

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Lesley Wong

OTHER

Sponsor Role: lead

Responsible Party

Lesley Wong

Associate Professor of Plastic Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lesley Wong, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

16-0064

Identifier Type: -

Identifier Source: org_study_id