Incisional Negative Pressure Wound Therapy for Prevention of Wound Healing Complications Following Reduction Mammaplasty

Abstract

Background: It has been proposed that negative pressure wound therapy (NPWT) applied prophylactically to a closed incision may decrease the incidence of wound complications. Patients undergoing reduction mammaplasty are at risk of wound complications such as delayed healing, infection, and dehiscence, and the bilateral nature of the surgery allows for a within-patient randomized study to evaluate incisional NPWT's effect in reducing healing complications.

Methods: In this multicenter trial, 200 patients undergoing bilateral reduction mammaplasty were treated with PICO Single-Use NPWT System or standard wound-care dressings randomized to right or left breast for up to 14 days to enable within-patient comparison. Follow-up assessments were conducted to evaluate the difference in incision healing complications up to 21 days postsurgery. Healing complications (for the primary endpoint) were defined as delayed healing (incision not 100% closed by 7 days) and occurrence of dehiscence or infection within 21 days. Individual healing complications were assessed separately as secondary endpoints.

Results: Significantly fewer healing complications (primary endpoint) were noted in NPWT-treated breasts [113 (56.8%)] versus standard care [123 (61.8%)]. The difference of 10 (5.0%) patients with fewer healing complications using NPWT was statistically significant (P = 0.004). NPWT also resulted in a significantly lower incidence of dehiscence (secondary endpoint) compared with standard care [32 patients (16.2%) versus 52 patients (26.4%)] by day 21, a relative reduction of 38% (P < 0.001).

Conclusions: This is the first major prospective, within-patient, randomized, controlled, multicenter study to provide evidence for an incisional NPWT strategy to reduce healing complications.

Fig. 1.

A, The PICO NPWT pump is lightweight (80 g) and measures 64 mm × 68 mm × 21 mm. It delivers −80 mm Hg and lasts for 7 days. There is no exudate canister and it is battery-powered. Exudate evaporates from the upper surface of the multilayer NPWT dressing, which transmits negative pressure across the surface of the wound. B, A patient from the trial randomized to receive PICO to the right breast following the reduction procedure. The dressing covers the entire lower incision, the T-junction, and much of the vertical incision except the nipple.

Fig. 2.

Patient disposition. Safety analysis set, n = 200 patients; full analysis set, n = 199 patients. One hundred seventy-eight patients (89.0%) completed the 90-day study; 22 patients (11%) were withdrawn: reasons were given as adverse event, n = 1 (0.5%); patient’s own request, n = 4 (2%); lost to follow-up, n = 14 (7%); and other, n = 3 (1.5%).

Fig. 3.

Frequency of complications during the postsurgical period in 199 patients treated with NPWT and SC. For the sensitivity analysis, the definition of delayed healing was changed from 7 to 10 days after surgery, with the aim that all patients should have returned for at least 1 visit at this point and we would therefore have complete information regarding closure. Using this cutoff, the results remained statistically significant [n = 79, 39.7% versus 89, 44.7% for NPWT and SC, respectively; treatment difference 5% (95% CI, 0.4–10.1); P = 0.033].

Fig. 4.

Proportion of patients reporting a dehiscence at each individual assessment.

Fig. 5.

Effect of body mass index on wound dehiscence.

Fig. 6.

Example of a patient with deep dehiscence on breast treated with SC and good healing on breast treated with NPWT.

Fig. 7.

Effect of tissue resection weight on dehiscence.