Tissue Expansion for Breast Reconstruction

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Wisconsin, Madison, WI
+1 More
Tissue Expansion - Procedure
Eligibility
18+
Female
Eligible conditions
Breast Reconstruction

Study Summary

This study is evaluating whether a patient can safely perform tissue expansions at home.

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Eligible Conditions

  • Breast Reconstruction
  • Tissue Expansion

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Tissue Expansion will improve 2 primary outcomes, 2 secondary outcomes, and 1 other outcome in patients with Breast Reconstruction. Measurement will happen over the course of up to 6 months.

up to 6 months
Incidence of Adverse Events
Incidence of Adverse Events in Left vs Right Breast Tissue Expansion
Number of Right and Left breast tissue expanders successfully exchanged from expander to implant
Participant Satisfaction Survey Score
Percent of Participants who had their breast tissue expanders successfully exchanged from expander to implant

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Home Expansion Group

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Tissue Expansion is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Home Expansion Group
Procedure
Participants in home expansion group will perform the saline injection for their right tissue expander under clinic staff supervision on their 2nd and 3rd expansion. Beginning their 4th expansion, participants will perform saline injection at home prior to their regularly scheduled clinic visit.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 months for reporting.

Closest Location

University of Wisconsin - Madison, WI

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
and bilateral Latissimus Dorsi flap reconstruction Having a double surgery to increase the size of your breasts using an implant, either right after the initial surgery or some time later, and then having implants placed in your chest using pieces of muscle from your back. show original
is a requirement for all studies In order to participate in a study, you must provide a signed and dated informed consent form. show original
The text states that the person is able and willing to present for clinic visits every 1-2 weeks to undergo tissue expansion. show original
of work roles and responsibilities The individual has the physical ability to complete the work, the perceptual ability to understand what is required, and the cognitive ability to learn and remember what is necessary show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How serious can tissue expansion be?

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Tissue expansion, especially in noncompliant skin and in high BMI patients, can be detrimental to the physical health of patients. The patient's general health must be considered and a plan generated prior to initiating the procedure.

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What causes tissue expansion?

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Results from a recent paper has shown that the tissue expansion, as used in patients with skin and/or oral mucous membrane transplantation, does not cause the common complications of tissue expansion after surgery, such as the appearance of new neovessels and, therefore, a worsening of skin redness and hyperpigmentation.

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Can tissue expansion be cured?

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There has been no clear proof of cure for TE. The use of a biopsy to obtain tissue (expander fill) from a different site would not be advisable, as biopsy specimens cannot always be reliably obtained. Since TE has been used for hundreds of years there can now be no question of its effectiveness as a treatment.

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How many people get tissue expansion a year in the United States?

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Approximately 35,000 people develop tissue expansion secondary to previous plastic surgery. Approximately 80-100 people develop a third of all tissue expander revisions. This article, however, highlights the most commonly used technique of tissue expansion and resultant morbidity and complications. The author highlights potential risk and adverse events associated with tissue expansion secondary to previous surgery, potential risks associated with the surgery such as bleeding, or necrosis, postoperative edema, and postoperative wound infection. Surgeons need to be aware of the potential risks of tissue expansion.

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What are the signs of tissue expansion?

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The most effective wound-healing technique is indicated for small and intermediate size tissue expanses. Because of large tissue expands, the most common signs are wound pain, swelling and erythema. To prevent excessive scars in large tissue expanses, the key factor is to keep wound margins flat and even.

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What is tissue expansion?

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The technique of tissue expansion is a surgical procedure utilizing a vascular network developed for the purpose of facilitating the expansion of the tissue needed for a prosthetic reconstruction. A vascular network in the tissue is a blood-forming meshwork composed of endothelial cells that grow to the site on the host where they attach and form a network of microscopic arterioles. This meshwork is composed of a network of capillaries and in the process, a small venous system is established that connects with the host venous system and allows the transport of nutrients and other molecules. The arterioles can extend and fill up the space with new tissues so that when the tissue is inserted, it retains its 3D form.

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Is tissue expansion typically used in combination with any other treatments?

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Recent findings did not detect any significant effect on clinical improvements or QoL when tissue expansion was combined with any other treatment other than orthopedic surgery.

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What are common treatments for tissue expansion?

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There are an increasing number of options available for people requiring tissue expansion. Current options do not always lead to the best outcomes, although it can be difficult to determine the best approach since this topic is still in its early stages of research and development. However, current evidence is still limited for common treatments for tissue expansion. More research must be conducted to determine the most effective treatments to use in individuals in order to lead them the best possible outcome.

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What is the average age someone gets tissue expansion?

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We find that young people are less likely than older people to gain a total facial expansion and a high total facial expansion, but the overall experience remains positive.

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Have there been any new discoveries for treating tissue expansion?

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There are many different factors that can affect the success or failure of tissue expansion. There are also many different types of tissue expansion solutions. This knowledge is useful for patients undergoing reconstruction or reconstruction therapy.

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What is the primary cause of tissue expansion?

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Results from a recent clinical trial suggests that a large proportion of patients have secondary causes for their soft tissue tissue expansion. Thus, soft tissue expansion would appear to be only a subset of a larger soft tissue expansion spectrum. Results from a recent clinical trial raises concerns regarding the appropriateness of soft tissue expansion by providing evidence for a lack of consensus among plastic and reconstructive surgeons and medical specialists, whether it be from previous knowledge or practice, as to the primary cause of soft tissue expansion.

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Who should consider clinical trials for tissue expansion?

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Clinical trials are most effective at recruiting patients for TET, and have little or no impact on patient survival. There is a strong bias in the literature towards trials of patients with early-stage HNSCC. In those who present with HNSCC there is a higher rate of survival due to higher rates of TERT, which makes their survival worse than if they participated in clinical trials; therefore, no clinical trial should be undertaken.

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