Galaflex Lite Scaffold for Surgical Adhesions
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how a new surgical mesh, Galaflex Lite Scaffold, can improve outcomes after a facelift (rhytidectomy). Researchers aim to determine if this mesh strengthens tissue, aids healing, and reduces scarring. It targets healthy individuals planning an elective facelift at UT Southwestern. Those with known reactions to certain materials or significant scars may not qualify.
As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance facelift procedures.
What prior data suggests that the Galaflex Lite Scaffold is safe for surgical use?
Research has shown that the Galaflex Lite Scaffold, made from poly-4-hydroxybutyrate (P4HB), is safe in various surgeries, including breast surgery. Studies indicate that patients generally tolerate this scaffold well, with many experiencing few significant side effects.
One study found that the Galaflex Lite Scaffold is as safe as other medical meshes used in surgeries, making it suitable for supporting soft tissues. The material is designed to be strong and aid healing as the body adapts to it.
Patients who have received this scaffold during surgeries have reported few issues, and it is considered safe for use in other approved medical procedures. While all medical treatments carry some risks, evidence suggests that the Galaflex Lite Scaffold is a safe choice for many patients.12345Why are researchers excited about this trial?
The Galaflex Lite Scaffold is unique because it uses poly-4-hydroxybutyrate (P4HB), a biodegradable material designed to reinforce soft tissue in patients undergoing plastic and reconstructive surgery. Unlike traditional surgical meshes that are often non-degradable and can lead to long-term complications, the P4HB material gradually dissolves over time, reducing the risk of chronic inflammation. Researchers are excited about this treatment as it promises prolonged strength retention while minimizing potential side effects commonly associated with other non-biodegradable options.
What evidence suggests that the Galaflex Lite Scaffold is effective for surgical adhesions?
Research shows that the Galaflex Lite Scaffold, made from P4HB, strengthens and supports healing tissue. Studies have found that this scaffold greatly improves tissue strength and flexibility over time. In one study, tissue strength noticeably improved 12 months after surgery. The scaffold supports tissue during healing, as natural tissue typically regains only about 80% of its original strength post-surgery. Thus, the Galaflex Lite Scaffold might reduce the need for additional surgeries by reinforcing soft tissue during the early healing process.26789
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-80 who are planning a facelift (rhytidectomy) at UT Southwestern with the study doctor. Participants must be willing to return for follow-up visits and undergo evaluations.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo elective rhytidectomy with the use of P4HB scaffold
Follow-up
Participants are monitored for tissue changes and satisfaction with facial appearance and outcome
What Are the Treatments Tested in This Trial?
Interventions
- Galaflex Lite Scaffold
Trial Overview
The trial is testing Galaflex Lite Scaffold, a surgical mesh, during facelift procedures to see how it affects tissue strength, elasticity, wound healing, and scar formation.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Healthy subjects who received an elective rhytidectomy The GalaFLEX LITE is a surgical mesh scaffold composed of poly-4-hydroxybutyrate (P4HB) developed to prolong strength retention and reinforce soft tissue in patients undergoing plastic and reconstructive surgery.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jeffrey M. Kenkel
Lead Sponsor
Citations
NCT05945329 | Study of GalaFLEX LITE™ Scaffold in ...
Prospective, randomized, controlled study to assess the safety and effectiveness of GalaFLEX LITE™ Scaffold in revision surgery for reduction of capsular ...
Why Support Matters | GalaFLEX™
And after surgery, native tissue only heals to 80% of its original strength.4; Within 10 years of plastic surgery, 32-48% of patients undergo a second procedure ...
Long-Term Efficacy and Safety of Poly-4-Hydroxybutyrate ...
From the 12th post-operative month onward, measurements in Group A showed a statistically significant difference (P < 0.05) compared to Group B, ...
BD Announces Milestone in Clinical Trial for Use of ...
... GalaFLEX™ LITE Scaffold in improving patient outcomes in breast revision surgeries. This study is crucial in providing the data FDA requires ...
5.
ctv.veeva.com
ctv.veeva.com/study/trial-of-device-that-is-not-approved-or-cleared-by-the-us-fda-845Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular ...
Prospective, randomized, controlled study to assess the safety and effectiveness of GalaFLEX LITE™ Scaffold in revision surgery for ...
Poly-4-hydroxybutyrate mesh (GalaFlex®) in aesthetic breast ...
This systematic review critically evaluates the efficacy, safety, and outcomes of P4HB mesh in aesthetic breast surgery, focusing on ...
GalaFLEX LITE™ Scaffold, 13.0cm Diameter (5.1in)
GalaFLEX LITE™ Scaffold is intended to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in ...
April 09, 2024 Tepha, Inc Rajagopalan Prithi Regulatory ...
The testing results demonstrate that Gala FLEX LITE Scaffold is substantially equivalent to the predicate device, TephaFLEX Light Mesh (Kl 13721 ) ...
9.
researchgate.net
researchgate.net/publication/396184989_Poly-4-Hydroxybutyrate_Mesh_GalaFlexR_in_Aesthetic_Breast_Surgery_A_Comprehensive_Systematic_Review(PDF) Poly-4-Hydroxybutyrate Mesh (GalaFlex®) in ...
This systematic review critically evaluates the efficacy, safety, and outcomes of P4HB mesh in aesthetic breast surgery, focusing on ...
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