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Randomized Controlled Trial
. 2023 Nov 16;43(12):NP1033-NP1048.
doi: 10.1093/asj/sjad269.

Postoperative Mechanomodulation Decreases T-Junction Dehiscence After Reduction Mammaplasty: Early Scar Analysis From a Randomized Controlled Trial

Jasmine Panton, Nicole Vingan, Jennifer Barillas, Yucel Akgul, Ariane Lazzarini, Christopher J Coroneos, Bardia Amirlak, Jeffrey Kenkel, Abby Culver
Randomized Controlled Trial

Postoperative Mechanomodulation Decreases T-Junction Dehiscence After Reduction Mammaplasty: Early Scar Analysis From a Randomized Controlled Trial

Jasmine Panton et al. Aesthet Surg J. .

Abstract

Background: Soft tissue and cutaneous tension is an important contributor to complicated wound healing and poor scar cosmesis after surgery and its mitigation is a key consideration in aesthetic and reconstructive procedures.

Objectives: The study objective was to assess the efficacy of the force modulating tissue bridge (FMTB) ("Brijjit", Brijjit Medical Inc., Atlanta, GA) in reducing mechanical tension on postoperative wounds.

Methods: A prospective, single-center, randomized, within-subject clinical trial was conducted to evaluate wound healing and nascent scar formation after 8 weeks of postoperative wound support with the FMTB. Patients received standard of care (SOC) subcuticular closure on the vertical incision of 1 breast and experimental closure with the FMTB on the contralateral incision after Wise-pattern reduction mammaplasty. Three-dimensional wound analysis and rates of T-junction dehiscence were evaluated by clinical assessment at 2, 4, 6, and 8 weeks postsurgery.

Results: Thirty-four patients (n = 68 breasts) completed 8 weeks of postoperative FMTB application. There was a reduced rate of T-junction wound dehiscence in FMTB breasts (n = 1) vs SOC breasts (n = 11) (P < .01). The mean vertical incision wound area during the intervention period was significantly decreased in the FMTB breast (1.5 cm2) vs the SOC breast (2.1 cm2) (P < .01) and was significantly lower at 2-, 4-, and 8-week follow-up (P < .01). Only the closure method was significantly associated with variations in Week 8 wound area (P < .01) after linear regression modeling.

Conclusions: FMTBs decrease nascent scar dimensions and reduce the occurrence of wound dehiscence. This study provides evidence that the use of continuous mechanomodulation significantly reduces postoperative wound complications after skin closure.

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Figures

Figure 1.
Figure 1.
Force modulating tissue bridge applicator and device.
Figure 2.
Figure 2.
Subject randomization and group allocation workflow. Patients were self-controlled to account for innate differences in wound healing and scar quality. FMTB, force modulating tissue bridge; SOC, standard of care. Figure created using Biorender.com.
Figure 3.
Figure 3.
Force modulating tissue bridge placement along vertical incision of 27-year-old female patient after Wise-pattern reduction mammaplasty. Following inverted interrupted dermal closure with 3-0 Monocryl (Ethicon, Raritan, NJ) along the vertical incision, force modulating tissue bridges were applied for final tissue approximation and superficial closure on the experimental breast.
Figure 4.
Figure 4.
A 27-year-old female patient undergoing Wise-pattern reduction mammaplasty with stand-of-care closure shown. In the control breast, inverted interrupted dermal closure was completed with 3-0 Monocryl (Ethicon, Raritan, NJ) suture along the vertical incision. Afterward, 4-0 running subcuticular Monocryl sutures were used for final tissue approximation and superficial closure on the contralateral incision, serving as a within-subject control.
Figure 5.
Figure 5.
Intervention period and study endpoints. 3D, three-dimensional. Figure created with Biorender.com (Toronto, Ontario, Canada).
Figure 6.
Figure 6.
Flow diagram of clinical trial. 34 patients were included in our preliminary analysis. FMTB, force modulating tissue bridge. Figure created with Biorender.com.
Figure 7.
Figure 7.
Clinical assessment of the vertical incision of a 35-year-old female patient during the postoperative intervention period. (A) Force modulating tissue bridge breast at 2-week follow-up and (B) at 4-week follow-up. (C) Standard-of-care breast at 2-week follow-up and (D) at 4-week follow-up.
Figure 8.
Figure 8.
Clinical assessment of the vertical incision of a 34-year-old female patient during the postoperative intervention period. (A) Standard-of-care breast at 2-week follow-up and (B) at 4-week follow-up. (C) Force modulating tissue bridge breast at 2-week follow-up and (D) at 4-week follow-up.
Figure 9.
Figure 9.
Clinical assessment of the vertical incision of a 36-year-old female patient during the postoperative intervention period. (A) Force modulating tissue bridge breast at 2-week follow-up and (B) at 8-week follow-up. (C) Standard-of-care breast at 2-week follow-up and (D) at 8-week follow-up.
Figure 10.
Figure 10.
eKare analysis of a vertical incision in a 55-year-old female. (A) Interface for three-dimensional measurement of a vertical incision closed with an FMTB. Metrics included in our analysis included nascent scar area, volume, and maximum depth during the 8-week postoperative intervention period. (B) Interface for three-dimensional imaging analysis of a vertical incision closed according to SOC. Metrics for FMTB and SOC breasts were recorded biweekly and analyzed by paired parametric testing. FMTB, force modulating tissue bridge; SOC, standard of care.
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References

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