Prophylaxis of Wound Infections-antibiotics in Renal Donation (POWAR): A UK Multicentre Double Blind Placebo Controlled Randomised Trial
Postoperative infection after hand-assisted laparoscopic donor nephrectomy (HALDN) confers significant morbidity to a healthy patient group. Current UK guidelines cite a lack of evidence for routine antibiotic prophylaxis. This trial assessed if a single preoperative antibiotic dose could reduce post HALDN infections.
METHODS:Eligible donors were randomly and blindly allocated to preoperative single-dose intravenous co-amoxiclav or saline. The primary composite endpoint was clinical evidence of any postoperative infection at 30 days, including surgical site infection (SSI), urinary tract infection (UTI), and lower respiratory tract infection (LRTI).
FINDINGS:In all, 293 participants underwent HALDN (148 antibiotic arm and 145 placebo arm). Among them, 99% (291/293) completed follow-up. The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001). Superficial SSIs were 20.7% (30/145 patients) in the placebo group versus 10.1% (15/148 patients) in the antibiotic group (P = 0.012). LRTIs were 9% (13/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.046). UTIs were 4.1% (6/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.72).Antibiotic prophylaxis conferred a 17.7% (95% confidence interval 7.2%-28.1%), absolute risk reduction in developing postoperative infection, with 6 donors requiring treatment to prevent 1 infection.
INTERPRETATION:Single-dose preoperative antibiotic prophylaxis dramatically reduces post-HALDN infection rates, mainly impacting SSIs and LRTIs.
CET Conclusion
| Reviewer: | Mr Simon Knight, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford |
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| Conclusion: | This multicentre UK study investigated the use of single-dose pre-operative antibiotics in hand-assisted donor nephrectomy. The study is randomised and blinded by use of a saline placebo. The investigators demonstrate a significant reduction in the risk of post-operative infection, including surgical site and lower respiratory tract infections. The study is well designed and reported, with clear outcome definitions. It is interesting that the baseline infection rate is considerably higher that that reported in the previous literature, which is likely due to under-reporting in retrospective studies rather than an excess of infection in the current study. Given the burden of infection in these patients, and the size of the reduction seen, it would appear that antibiotic prophylaxis is warranted. It is, however, not clear whether these findings extend to patients undergoing fully laparoscopic nephrectomy. |
Methodological quality
| Jadad score | 5 |
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| Allocation concealment | YES |
| Data analysis | STRICT INTENTION TO TREAT |
Study Details
| Aims: | This study aimed to assess if a single preoperative antibiotic dose can reduce post hand-assisted laparoscopic donor nephrectomy (HALDN) infections. |
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| Interventions: | Patients were randomized to receive either intravenous co-amoxiclav 1.2g or the equivelant volume of normal saline (0.9% saline) at the time of induction of anesthesia. |
| Participants: | 293 adult renal transplant donors undergoing HALDN. Patients who had a known allergy or previous adverse rection due to antibiotics were excluded. |
| Outcomes: | Primary outcomes being assessed comprised postoperative infections, including, surgical site infections (SSIs), urinary tract infections (UTIs) and lower respirtory tract infections (LRTIs). Secondary outcomes included postoperative hospital stay, 30-day readmission rates and reoperation rates. |
| Follow Up: | 30 days |
Metadata
| Publication type: | Multicenter Study, Randomized Controlled Trial, Randomised Controlled Trial |
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| Organ: | Kidney |
| Language: | English |
| MeSH terms: | Adult; Amoxicillin-Potassium Clavulanate Combination; Antibiotic Prophylaxis; Double-Blind Method; Female; Humans; Laparoscopy; Living Donors; Male; Middle Aged; Nephrectomy; Respiratory Tract Infections; Surgical Wound Infection; United Kingdom; Urinary Tract Infections; 74469-00-4 (Amoxicillin-Potassium Clavulanate Combination); Kidney Transplantation |