Bilayered negative-pressure wound therapy preventing leg incision morbidity in coronary artery bypass graft patients: A randomized controlled trial

Abstract

Backgrounds: The harvesting of great saphenous veins for coronary artery bypass graft (CABG) patients may result in significant complications, including lymphorrhagia, lymphoedema, incision infection, wound dehiscence, and skin flap necrosis. We investigated the function of a self-designed bilayered negative pressure wound therapy (b-NPWT) for reducing the above-mentioned complications using a clinical randomized controlled trial.

Methods: A single-center, pilot randomized controlled trial was conducted. From December 2013 to March 2014, a total of 72 coronary heart disease patients (48 men and 24 women) received CABG therapy, with great saphenous veins were selected as grafts. Patients were equally randomized into a treatment and a control group. After the harvesting of the great saphenous veins and direct closure of the wound with sutures, b-NPWT was used for the thigh incision in the treatment group for 5 days (treatment thigh). Traditional surgical pads were applied to both the shank incisions of the treatment group patients (treatment shank) and the entire incisions of the control group (control thigh, control shank). Postoperative complications were recorded and statistically analyzed based on outcomes of thigh treatment, shank treatment, thigh control, and shank control groups.

Results: The incidence rates of early complications, such as lymphorrhagia, lymphoedema, infection, wound dehiscence, and skin flap necrosis, of the vascular donor site in the thigh treatment group was significantly lower than those in the 3 other groups.

Conclusions: The self-designed b-NPWT can effectively reduce postoperative complications, such as lymphedema, incision infection, wound dehiscence, and skin flap necrosis, in CABG patients who underwent great saphenous veins harvesting.

Trial registration: ClinicalTrials.gov. The unique registration number is NCT02010996.

Figure 1

Diagrammatic sketch of b-NPWT implementation. A: Harvest of a great saphenous vein through an interrupted incision in the lower limb. B: Insertion of a drainage tube into the bottom of the wound. C: After closure of the incision with sutures, the skin surface of the thigh was protected with multiple vaseline gauzes in which the second drainage tube was inserted. D: The gauze was fixed and compressed on the skin with adhesives tape, and 2 tubes were connected to a negative pressure source (−120 mm Hg) followed by sustained vacuum suction. E: Gloss view of the b-NPWT in a patient. b-NPWT = bilayered negative pressure wound therapy.

Figure 2

Typical cases and long-term follow up. The b-NPWT treatment was immediately implemented covering incision in the thigh of treatment group (A), and removed in day 5 (C), while traditional surgical pad was used to protect the wound in control group in the same period (B, D). Skin and subcutaneous tissue edema (F, G, and H) occurred in T-shank, C-thigh, and C-shank (yellow arrow) without exception; in contrast, local skin remained in contractive appearance in T-thigh for several days after the cessation of b-NPWT (E). Significant complications occurred in T-shank, C-thigh, and C-shank (J, K, L, red arrow), including lymphorrhagia, incision infection, and wound dehiseence, while the incision healed unevenly in T-thigh (I) without hypertrophic scar (M) that usually formed in the control site (N, O, P) during 3 months’ follow up. C-shank = control shank, C-thigh = control thigh, T-shank = treatment shank, T-thigh = treatment thigh.