Clinical Evaluation of Hyaluronic Acid Sponge with Zinc versus Placebo for Scar Reduction after Breast Surgery.

Scar formation after surgery and skin trauma is a major source of dissatisfaction among patients and surgeons.1 Some scars can be disfiguring and esthetically unpleasant and cause severe itching, tenderness, pain, and psychological disturbance. They can also diminish quality of life and result in posttraumatic stress reactions, loss of self-esteem, and stigmatization.2–4 Furthermore, discernible scarring is a major complication and a major cause of reoperation after breast surgery.5 Attempts to reduce scarring after plastic surgery, particularly breast surgery, have traditionally focused on choosing well-hidden incision sites and using silicon sheets, corticosteroid injections, and massage therapy postoperatively.6,7 Inflammation is the most important physiologic response to any form of wounding. The outcome of controlled inflammation in adults is a collagenous scar, which lacks the ordered structure of healthy skin.8 Fetal healing, on the other hand, resembles a regenerative process and does not result in a collagenous scar.9–11 Pathogenesis of scar deformity is still unclear. When the skin is injured, the first glycosaminoglycan to be synthesized is hyaluronan, or hyaluronic acid (HA).12 Fetal healing is scarless and occurs in an environment rich in HA,9 suggesting that exogenous HA may be useful in wound repair in adults.13–18 Evidence suggests that using suitable HA under appropriate conditions leads to enhanced wound healing and a reduction in or elimination of scarring.19 More than 50% of the body’s HA is found in the skin, where it functions to stabilize and maintain the biomatrix between the cells.20,21 The intrinsic water-retaining capacity of HA suggests that it facilitates the transport of metabolites and preserves tissue hydration, especially in the dermal layer.22 In the early 1970s, Rydell13 observed that application of high-molecular weight, purified HA to surgical incisions in animals resulted in subcutaneous scars that were smoother with less connective tissue reaction than those of untreated incisions in the same animals. Although HA is not the sole factor in regulating wound repair, it is certainly a key factor. It modulates inflammation by affecting polymorphonuclear cells, macrophages, cells of the lymphomyeloid system, phagocytosis, and chemotaxis and is a scavenger of free radicals.23 Various HA formulations have been produced to help reduce scarring.24 One such formulation is the HA sponge (HylaSponge System, Matrix Biological Institute, Fort Lee, N.J.), which uses polymerization methods to produce a network of large HA molecular chains bound into an assembly of very large coils (Fig. ​(Fig.1).1). These coils form spheroidal particles of virtually infinite molecular weight. The spheroidal particles can absorb and release large volumes of water, or water-soluble molecules, much like a sponge. This system provides a “waterway” to the skin for large- and small-molecular weight HAs and biologically active molecules incorporated into them, thus providing longer lasting effects and more penetrating hydration.25 Fig. 1. Hyaluronic acid sponge with zinc system. A, Hyaluronan sponge system with soluble hyaluronan of large molecular weight, soluble hyaluronan of small molecular weight, and biologically active molecules still within the sponge system. Stratum corneum is ... The HA sponge system acts as a “second skin” and retains much of its water while delivering active components to the skin. The space in between the HA sponges is occupied by large-molecular weight, soluble HA (2) (Fig. ​(Fig.1A).1A). Small-molecular weight, soluble HA (3) is inside and around the HA sponge. Optional additions of biologically active small molecules (4) such as vitamins, amino acids, and peptides are distributed in the water around and filling the HA sponges. The system releases water to the skin, enabling diffusion of the large (2) and small (3) HA molecules and the (4) biologically active molecules into the stratum corneum (5) of the skin, with the latter 2 molecules diffusing toward the deeper layers of the skin (Fig. ​(Fig.11B). In this randomized prospective study, we evaluated the safety and efficacy of the HA sponge with zinc compared with placebo in the management of bilateral breast surgery scars. Specifically, we evaluated whether this product modulates inflammation and immediate scarring in treated patients after bilateral breast surgery. The moisture-intensive serum draws on the antibacterial and antiinflammatory properties of zinc to promote enhanced healing.