Force Modulating Tissue Bridges for Closure after Breast Reduction: Preliminary Findings from a Randomized Controlled Trial Assessing Wound Healing and Scar Quality
Excess tension on surgical incisions attenuates postoperative healing and is known to contribute to unfavorable scarring. In patients undergoing Wise-pattern breast reduction, the inverted T-junction of the vertical and inframammary incision is common site of complications including delayed wound healing, dehiscence, and breakdown.
Force modulating tissue bridges (FMTB; “Brijjit", BrijjitCo, LLC, Atlanta, GA) represent a novel, non-invasive device which offsets skin tension and modulates mechanical force concentrations at the surgical site. In this randomized self-controlled study, we sought to prospectively assess wound healing and scar aesthetic in the vertical incision of Wise-pattern breast reductions, comparing FMTB-closed (treatment) incisions to those closed using standard of care technique (control).
Methods/Technique:
This study is a single-center, IRB-approved, prospective, randomized controlled trial conducted at a large academic center over 12 months. Eligible subjects between 18 and 70 years of age underwent modified Wise-pattern reduction mammaplasty. Patients were self-controlled; depending on randomization, the vertical incision of one breast underwent dermal closure according to the standard of care and the vertical incision of the contralateral breast underwent dermal closure using force modulating tissue bridges (Figure 1).
Primary endpoints included clinical wound characterization and complication rate, and live and photography-based clinical assessment of scar quality and appearance. Patient and observers provided in-person assessments of scars using the Patient and Observer Scar Assessment Scale (POSAS) at 2-, 3-, and 6-month follow-up visits. Blinded clinicians used photographs to assess vertical incision scars at 3- and 6-month follow-up using a visual analog rating scale. Descriptive statistics were used to summarize the results of both in-person and photography-based assessment.
Results/Complications:
27 of an anticipated cohort of 42 patients have enrolled in the study with a mean age of 42 years. To date, 22 women have undergone Wise-pattern breast reduction. 20 subjects have completed eight weeks of postoperative FMTB therapy, 13 have completed 3-month follow-up, and nine have completed 6-month follow-up. No serious adverse events were reported. Additional long-term follow-up data will be presented at The Aesthetic Meeting.
The mean total patient and observer POSAS scores of FMTB scars were more favorable compared with control-closure scars across all follow-up periods. The mean patient POSAS score of FMTB-closure scars (11.6) was improved compared to control closure scars (12.7) at 6-month follow-up. Similarly, the mean observer POSAS score of FMTB closure scars (10.3) was improved compared to control closure scars (11.4) at 6 months.
Overall, the mean visual analog score for FMTB-closure scars (3.0) was more favorable compared to control-closure scars (3.5). At 3- and 6-month follow-up, clinicians rated FMTB-closure scars (2.8 vs. 3.3) more favorably compared to control closure scars (3.4 vs. 3.7).
Conclusion:
These results, while preliminary, demonstrate that force modulating tissue bridges may support the healing of surgical incisions in the postoperative period and improve the appearance of scars up to 6 months following breast reduction surgery. Ongoing data collection and analysis will help determine the significance of our findings up to 12 months after surgery.