Negative Pressure Wound Therapy on Surgical Site Infections in Women Undergoing Elective Caesarean Sections: A Pilot RCT

Abstract

Obese women undergoing caesarean section (CS) are at increased risk of surgical site infection (SSI). Negative Pressure Wound Therapy (NPWT) is growing in use as a prophylactic approach to prevent wound complications such as SSI, yet there is little evidence of its benefits. This pilot randomized controlled trial (RCT) assessed the effect of NPWT on SSI and other wound complications in obese women undergoing elective caesarean sections (CS) and also the feasibility of conducting a definitive trial. Ninety-two obese women undergoing elective CS were randomized in theatre via a central web based system using a parallel 1:1 process to two groups i.e., 46 women received the intervention (NPWT PICO™ dressing) and 46 women received standard care (Comfeel Plus® dressing). All women received the intended dressing following wound closure. The relative risk of SSI in the intervention group was 0.81 (95% CI 0.38–1.68); for the number of complications excluding SSI it was 0.98 (95% CI 0.34–2.79). A sample size of 784 (392 per group) would be required to find a statistically significant difference in SSI between the two groups with 90% power. These results demonstrate that a larger definitive trial is feasible and that careful planning and site selection is critical to the success of the overall study.

Cost-effectiveness analysis alongside a pilot study of prophylactic negative pressure wound therapy

“…Table 2 shows summary statistics for the characteristics of the two treatment groups. As reported by REFERENCE REMOVED FOR BLINDING [17], patients receiving the standard treatment were more likely to smoke (p=0.032) and had longer average surgery time (p=0.002). They were also more likely to receive antibiotics post-surgery (p=0.021), typically due to surgeon concerns about potential complications.…”

“…As noted by REFERENCE REMOVED FOR BLINDING [17] and seen in Table 2, the two treatment groups may not be comparable. Patients receiving standard treatment were more likely to smoke, had longer average surgery times and were more likely to receive prophylactic antibiotics after surgery.…”

“…The design of the pilot study has been described in detail elsewhere [17]. The pilot study was a prospective, single site randomised controlled trial (RCT).…”

“…For both groups, the cost of days in hospital accounted for the majority of the costs of treatment. REFERENCE REMOVED FOR BLINDING reported the effectiveness of NPWT based on median outcomes [17]. Table 4 presents analysis comparison of outcomes focusing on the mean values which better reflects the requirements of an economic analysis [26].…”

Cost-utility analysis of negative pressure wound therapy in high-risk cesarean section wounds

“…Furthermore, to ensure that all relevant evidence was included in the model, data from a recent pilot study conducted by our group were included and combined with already available evidence. The details of the pilot trial are published elsewhere [36]. In brief, that trial assessed the effect of NPWT on SSI in obese women undergoing elective CS in addition to the feasibility of 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323...…”