ABSTRACT
OBJECTIVE: To evaluate the cost-effectiveness of incisional negative pressure wound therapy (iNPWT) in preventing surgical site infection in obese women after caesarean section. DESIGN: A cost-effectiveness analysis conducted alongside a clinical trial. SETTING: Five obstetric departments in Denmark. POPULATION: Women with a pregestational body mass index (BMI) ≥30 kg/m2 . METHOD: We used data from a randomised controlled trial of 876 obese women who underwent elective or emergency caesarean section and were subsequently treated with iNPWT (n = 432) or a standard dressing (n = 444). Costs were estimated using data from four Danish National Databases and analysed from a healthcare perspective with a time horizon of 3 months after birth. MAIN OUTCOME MEASURES: Cost-effectiveness based on incremental cost per surgical site infection avoided and per quality-adjusted life-year (QALY) gained. RESULTS: The total healthcare costs per woman were 5793.60 for iNPWT and 5840.89 for standard dressings. Incisional NPWT was the dominant strategy because it was both less expensive and more effective; however, no statistically significant difference was found for costs or QALYs. At a willingness-to-pay threshold of 30,000, the probability of the intervention being cost-effective was 92.8%. A subgroup analysis stratifying by BMI shows that the cost saving of the intervention was mainly driven by the benefit to women with a pre-pregnancy BMI ≥35 kg/m2 . CONCLUSION: Incisional NPWT appears to be cost saving compared with standard dressings but this finding is not statistically significant. The cost savings were primarily found in women with a pre-pregnancy BMI ≥35 kg/m2 . TWEETABLE ABSTRACT: Prophylactic incisional NPWT reduces the risk of SSI after caesarean section and is probably dominant compared with standard dressings #healtheconomics.
Subject(s)
Bandages/economics , Cesarean Section/adverse effects , Negative-Pressure Wound Therapy/economics , Obesity/surgery , Pregnancy Complications/surgery , Surgical Wound Infection/prevention & control , Adult , Cesarean Section/methods , Cost-Benefit Analysis , Denmark , Female , Humans , Pregnancy , Quality-Adjusted Life Years , Standard of Care/economics , Surgical Wound Infection/economics , Treatment OutcomeABSTRACT
OBJECTIVE: To evaluate the reduction of surgical site infections by prophylactic incisional negative pressure wound therapy compared with standard postoperative dressings in obese women giving birth by caesarean section. DESIGN: Multicentre randomised controlled trial. SETTING: Five hospitals in Denmark. POPULATION: Obese women (prepregnancy body mass index (BMI) ≥30 kg/m2 ) undergoing elective or emergency caesarean section. METHOD: The participants were randomly assigned to incisional negative pressure wound therapy or a standard dressing after caesarean section and analysed by intention-to-treat. Blinding was not possible due to the nature of the intervention. MAIN OUTCOME MEASURES: The primary outcome was surgical site infection requiring antibiotic treatment within the first 30 days after surgery. Secondary outcomes included wound exudate, dehiscence and health-related quality of life. RESULTS: Incisional negative pressure wound therapy was applied to 432 women and 444 women had a standard dressing. Demographics were similar between groups. Surgical site infection occurred in 20 (4.6%) women treated with incisional negative pressure wound therapy and in 41 (9.2%) women treated with a standard dressing (relative risk 0.50, 95% CI 0.30-0.84; number needed to treat 22; P = 0.007). The effect remained statistically significant when adjusted for BMI and other potential risk factors. Incisional negative pressure wound therapy significantly reduced wound exudate whereas no difference was found for dehiscence and quality of life between the two groups. CONCLUSION: Prophylactic use of incisional negative pressure wound therapy reduced the risk of surgical site infection in obese women giving birth by caesarean section. TWEETABLE ABSTRACT: RCT: prophylactic incisional NPWT versus standard dressings postcaesarean in 876 women significantly reduces the risk of SSI.
Subject(s)
Cesarean Section/adverse effects , Negative-Pressure Wound Therapy/methods , Obesity/surgery , Pregnancy Complications/surgery , Surgical Wound Infection/prevention & control , Adult , Bandages/statistics & numerical data , Denmark , Female , Humans , Obesity/complications , Pregnancy , Risk Factors , Standard of Care/statistics & numerical data , Surgical Wound Infection/etiology , Treatment Outcome , Wound HealingABSTRACT
AIM: No information was available on how fast intravenous cefuroxime administered to pregnant women before a Caesarean section was cleared in newborn infants. This study investigated the drug's half-life and the exposure of healthy newborn infants after their mothers received the drug. METHODS: Healthy mothers received a single dose of cefuroxime 15-60 minutes before skin incision. One blood sample was drawn from the umbilical cord, and two blood samples were drawn from the infant after delivery. Total plasma cefuroxime (µg/mL) was measured using high-pressure liquid chromatography. RESULTS: Cefuroxime was given to 22 mothers, including two who had twins. The concentration of cefuroxime varied significantly among infants (p < 0.001), while the rate of decline did not (p = 0.24). The median cefuroxime half-life was 3.5 hours (range 2.9-5.5), which was approximately three times longer than in normal adults and seemed to clear within 24 hours. The median area under the concentration-time curve was 65.0 hour µg/mL (range 31.7-162.4). CONCLUSION: We found that the cefuroxime half-life after a Caesarean section varied among infants and was longer than in normal adults but cleared within 24 hours. Exposure to cefuroxime in newborn infants may influence the gut microbiota and should be investigated further.
Subject(s)
Anti-Bacterial Agents/pharmacokinetics , Antibiotic Prophylaxis/adverse effects , Cefuroxime/pharmacokinetics , Cesarean Section , Infant, Newborn , Half-Life , Humans , Surgical Wound Infection/prevention & controlABSTRACT
BACKGROUND: Postoperative wound complications are common following surgical procedures. Negative-pressure wound therapy (NPWT) is well recognized for the management of open wounds and has been applied recently to closed surgical incisions. The evidence base to support this intervention is limited. The aim of this study was to assess whether NPWT reduces postoperative wound complications when applied to closed surgical incisions. METHODS: This was a systematic review and meta-analysis of randomized clinical trials of NPWT compared with standard postoperative dressings on closed surgical incisions. RESULTS: Ten studies met the inclusion criteria, reporting on 1311 incisions in 1089 patients. NPWT was associated with a significant reduction in wound infection (relative risk (RR) 0·54, 95 per cent c.i. 0·33 to 0·89) and seroma formation (RR 0·48, 0·27 to 0·84) compared with standard care. The reduction in wound dehiscence was not significant. The numbers needed to treat were three (seroma), 17 (dehiscence) and 25 (infection). Methodological heterogeneity across studies led to downgrading of the quality of evidence to moderate for infection and seroma, and low for dehiscence. CONCLUSION: Compared with standard postoperative dressings, NPWT significantly reduced the rate of wound infection and seroma when applied to closed surgical wounds. Heterogeneity between the included studies means that no general recommendations can be made yet.