Clinical Trials Logo

Clinical Trial Summary

This is a prospective, within-subject randomized, single blinded study designed to follow up to forty-two (42) qualified and consenting adult females, 18-65 years of age scheduled for elective breast reduction surgery using a standard inverted Wise (inverted "T") incision pattern


Clinical Trial Description

This is a prospective, within-subject randomized, single blinded study designed to follow up to forty-two (42) qualified and consenting adult females, 18-65 years of age scheduled for elective breast reduction surgery using a standard inverted Wise (inverted "T") incision pattern. Subjects will be randomized to the method of closure and wound support of the symmetrical vertical breast incisions. On the intervention side subjects will have FMTBs applied for final layer closure of the vertical breast incision and will continue with repeat application every two weeks for ongoing wound support for a total of 8 weeks of therapy. On the control side standard suture closure and wound dressings will be utilized. Patients will be evaluated at two-week intervals up until 8 weeks post-operative, then will have 3 additional follow up visits at 3-months, 6-months and 12-months post-operatively. The effects of the therapy will be analyzed during the follow up visits through photography, skin assessments and POSAS (Patient and Observer Scar Assessment Scale) results. A subgroup of 10 patients will also undergo biopsies of the area of interest at five time points throughout the study. Primary study outcomes include POSAS results and photographic assessment while secondary outcomes include scar volume/surface area, gene regulation and genetic analysis obtained via biopsies, collagen volume, skin assessments, colorimetry and time of length of adherence of the device. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05028816
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact Jennife Barillas
Phone 214-645-8907
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date October 1, 2021
Completion date July 1, 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04888624 - A Comparison Between Two Post-operative Dressings N/A
Terminated NCT03688880 - A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced N/A
Recruiting NCT02989363 - Evaluation of the Use of Resources and Costs N/A
Completed NCT03199911 - Topical Antibiotic Prophylaxis for Eyelids Phase 4
Not yet recruiting NCT04053946 - Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC N/A
Recruiting NCT04336371 - Exploratory Prospective of Experienced by Patients in the Surgery of Skin Cancers of the Face in Interventional Dermatology Department
Not yet recruiting NCT04250649 - Does Disinfection of the Subcutaneous Tissue Reduce Contamination of the Operating Field With P. Acnes? N/A
Completed NCT03860181 - Dermabond PRINEO for Total Shoulder Arthroplasty N/A
Enrolling by invitation NCT03180346 - A Prospective, Randomized, Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO) or Standard Care Dressings (AQUACEL Ag SURGICAL Dressing). N/A
Completed NCT02975765 - Evaluation of the Levels of Pain and Discomfort Between Two Methods of Correcting Misaligned Teeth N/A
Completed NCT02977221 - Efficacy of Piezosurgey Corticotomy (a Minimally Invasive Surgical Technique) in Accelerating Orthodontic Alignment N/A
Not yet recruiting NCT04894604 - A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions N/A
Completed NCT03644316 - BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery N/A
Not yet recruiting NCT04110353 - Prophylactic Closed Incision Negative Pressure Wound Therapy on Abdominal Wounds - Clinical and Economic Perspectives N/A
Recruiting NCT04191993 - Direct Superior Approach (DSA) vs Posterior Approach (PA) in THA N/A
Recruiting NCT03561376 - Zinc Oxide Versus Petrolatum Following Skin Surgery Early Phase 1
Not yet recruiting NCT04998513 - Medical Versus Surgical Treatment for Peritonsillar Abscesses N/A
Completed NCT02992951 - DACC in the REduction of Surgical Site INfection N/A
Completed NCT03499769 - Comparison of NOSE and Conventional Methods in Laparoscopic Total Colon Surgery N/A
Completed NCT03487289 - Comparison of NOSE and Conventional Methods in Laparoscopic Right Colon Surgery N/A