Effectiveness of prophylactic subcutaneous negative-pressure drainage for the prevention of surgical site infection in gynaecological cancer patients with BMI ≥ 35 kg/m2: a multicentre open-label randomized trial.

OBJECTIVE

To evaluate whether prophylactic subcutaneous negative-pressure drainage reduces the incidence of surgical site infection (SSI) after laparotomy in morbidly obese women undergoing surgery for gynaecological malignancy.

METHODS

In this multicentre open-label randomized trial, 200 women with body mass index (BMI) > 35 kg/m2 were allocated to receive subcutaneous drainage using a Redon drain for at least 3 postoperative days or standard wound closure without drainage. The primary outcome was SSI within 30 days. Secondary outcomes included surgical debridement for SSI, wound haematoma, seroma, wound dehiscence, wound-related fever, duration of antibiotic therapy, length of hospital stay, and 30-day re-admission.

RESULTS

Data from 191 patients were analysed. Median BMI was 39 kg/m2. The incidence of SSI was comparable between the drainage and control groups (15.5% vs 14.9%; p = 0.913). Drain placement reduced postoperative wound haematoma significantly (1.0% vs 7.4%; p = 0.027). Postoperative fever occurred more frequently in the drainage group (18.5% vs 8.5%; p = 0.057). Although this difference did not reach significance, exploratory multivariable analysis demonstrated a similar trend (adjusted odds ratio 2.47, 95% confidence interval 0.98-6.22), suggesting that a clinically relevant increase in postoperative fever cannot be excluded. No differences in overall uncomplicated wound healing were observed.

CONCLUSION

Subcutaneous negative-pressure drainage did not significantly reduce the incidence of SSI following abdominal hysterectomy in morbidly obese patients with gynaecological cancer. Of all predefined secondary outcomes, only postoperative wound haematoma was reduced significantly. Conversely, both the unadjusted and adjusted analyses suggested a potential increase in postoperative fever, although significance was not reached. As these were secondary outcomes, they should be interpreted with caution.