Use of Negative-Pressure Wound Dressings to Prevent Surgical Site Complications After Primary Hip Arthroplasty: A Pilot RCT.

PURPOSE: Negative-pressure wound therapy (NPWT) is increasingly used for primary surgical incisions despite the paucity of evidence. Study objectives were to assess the use of NPWT on surgical sites to prevent infections and other wound complications after elective primary hip arthroplasty and to consider feasibility of a larger trial.
METHODS: A nonmasked, randomized controlled pilot trial. Patients were recruited preoperatively from the preadmission clinic of an Australian hospital during 2013-2014. Computer-generated randomization was performed with allocation concealed until completion of surgery. The intervention group received NPWT (PICO) while the control group received the standard care hydrocolloid, reinforced with 2 absorbent dressings. Patients were followed for 6 weeks for postoperative complications (infection, length of stay, readmission) and skin complications (bruising, seroma, hematoma, dehiscence). Feasibility end points included numbers recruited, randomized, and followed up; fidelity; and costs.
RESULTS: Of 77 people approached, 76 were recruited, and 70 were randomized. Of 35 in the negative-pressure group, 2 received the standard dressing. Attrition at 6 weeks exceeded 10% in both groups. Dressing costs were lower in the control group ($3.01/d vs $38.40/d); SSI incidence was 2/35 in the NPWT and 3/35 in the control group (intention to treat: risk ratio [RR] = 0.67; 95% confidence interval [CI] = 0.12-3.7; P = .65). NPWT patients experienced more postoperative wound complications (RR = 1.6; 95% CI = 1.0-2.5; P = .04).
CONCLUSION: A reduction of 3% in SSI incidence suggests that a definitive trial requires approximately 900 patients per group. Yet there is uncertainty around the benefit of NPWT after elective hip arthroplasty.

RCT Entities:   Population Interventions Outcomes