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Trial record 1 of 1 for:    NCT02725801
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Comparison of One-port and Two-port Tissue Expanders for Breast Reconstruction

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ClinicalTrials.gov Identifier: NCT02725801
Recruitment Status : Recruiting
First Posted : April 1, 2016
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Lesley Wong, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Allergen one-port tissue expander placement Device: AlloX2 two-port tissue expander placement Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing 1-Port and 2-Port Tissue Expanders for Breast Reconstruction
Study Start Date : February 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: AlloX2 two-port tissue expander




Primary Outcome Measures :
  1. Successful replacement of tissue expander with permanent implant [ Time Frame: 3 months ]
    the number of patients that are able to undergo replacement of the tissue expander between the two arms will be compared


Secondary Outcome Measures :
  1. need for additional intervention [ Time Frame: 3 months ]
    The types and numbers of additional intervention following tissue expander placement will be compared between the two arms of the study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725801


Contacts
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Contact: Lesley Wong, MD 859-323-4263 lesley.wong@uky.edu
Contact: Betsy Fink 859-323-6328 betsy.fink@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Lesley Wong, MD    859-323-4263    lesley.wong@uky.edu   
Contact: Betsy Fink    859-323-6328    betsy.fink@uky.edu   
Sponsors and Collaborators
Lesley Wong
Investigators
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Principal Investigator: Lesley Wong, MD University of Kentucky

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Responsible Party: Lesley Wong, Associate Professor of Plastic Surgery, University of Kentucky
ClinicalTrials.gov Identifier: NCT02725801     History of Changes
Other Study ID Numbers: 16-0064
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No