Antiseptic Skin Agents to Prevent Surgical Site Infection After Incisional Surgery: A Randomized, Three-armed Combined Non-inferiority and Superiority Clinical Trial (NEWSkin Prep Study).
Study Goal
The researchers aimed to compare the effectiveness of iodine-based skin preparation solutions (PI-Alc and PI-Aq) against chlorhexidine with alcohol (C-Alc) in preventing surgical site infections (SSIs).
Results Summary
PI-Alc was non-inferior to C-Alc in preventing SSIs (10.88% vs. 11.09%), but not superior to PI-Aq (10.88% vs. 12.56%). No differences were observed in secondary outcomes, and no treatment-related adverse events or deaths occurred.
Population
3213 surgical patients (mean age 57, 55% female).
Effective Dosage
Not specified (skin preparation solutions used preoperatively).
Duration
Intervention duration not explicitly stated (study conducted from January 2015 to December 2018).
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
povidone-iodine with alcohol (PI-Alc) | no change | SSI rate | patients | mean difference, -0.21%; 95% confidence interval, -2.85 to 2.44; P = 0.0009 non-inferiority | was found to be non-inferior | #1 |
povidone-iodine with alcohol (PI-Alc) | no change | SSI rate | patients | mean difference, -1.68%; 95% confidence interval, -4.40 to 1.05; P = 0.2302 | was not superior | #2 |
chlorhexidine with alcohol (C-Alc) | neutral | SSI rate | patients | 11.09% | SSI rates were | #3 |
povidone-iodine with alcohol (PI-Alc) | neutral | SSI rate | patients | 10.88% | SSI rates were | #4 |
povidone-iodine aqueous (PI-Aq) | neutral | SSI rate | patients | 12.56% | SSI rates were | #5 |
povidone-iodine with alcohol (PI-Alc) | no change | secondary outcomes | patients | - | no differences seen | #6 |
chlorhexidine with alcohol (C-Alc) | no change | secondary outcomes | patients | - | no differences seen | #7 |
povidone-iodine aqueous (PI-Aq) | no change | secondary outcomes | patients | - | no differences seen | #8 |
povidone-iodine with alcohol (PI-Alc) | no change | adverse events or deaths | patients | - | no treatment related adverse events or deaths occurred | #9 |
chlorhexidine with alcohol (C-Alc) | no change | adverse events or deaths | patients | - | no treatment related adverse events or deaths occurred | #10 |
povidone-iodine aqueous (PI-Aq) | no change | adverse events or deaths | patients | - | no treatment related adverse events or deaths occurred | #11 |
OBJECTIVE: To compare SSI rates between the skin preparation agents: PI-Aq, povidone-iodine with alcohol (PI-Alc), and chlorhexidine with alcohol (C-Alc). BACKGROUND: Guidelines suggest that alcohol-containing chlorhexidine solutions are the gold standard for skin preparation before surgery. It remains difficult to determine whether it is the chlorhexidine component or the addition of alcohol that confers the most benefit. METHODS: We conducted a multicenter, prospective, combined non-inferiority (PI-Alc vs C-Alc) and superiority (PI-Alc vs PI-Aq) randomized clinical trial. Participants were randomized 1:1:1 to receive either C-Alc, PI-Alc, or PI-Aq. The primary outcome was SSI rate as defined by the Centers for Disease Control. Secondary outcomes were complication rates, length of hospital stay, readmissions, and skin reactions. RESULTS: Between January 2015 and December 2018, 3213 patients were randomized (C-Alc: 1076, PI-Alc: 1075, and PI-Aq: 1062). Mean age of participants was 57% and 55% were female. SSI rates were: C-Alc 11.09%, PI-Alc 10.88%, and PI-Aq 12.56%. PI-Alc was found to be non-inferior to C-Alc (mean difference, -0.21%; 95% confidence interval, -2.85 to 2.44; P = 0.0009 non-inferiority), whereas PI-Alc was not superior to PI-Aq (mean difference, -1.68%; 95% confidence interval, -4.40 to 1.05; P = 0.2302). There were no differences seen in secondary outcomes between groups and no treatment related adverse events or deaths occurred. CONCLUSIONS: PI-Alc is non-inferior to C-Alc and not superior to PI-Aq. This is at odds with current guidelines that suggest alcohol-based chlorhexidine solutions should routinely be used for surgical skin preparation. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry: ANZCTRN12615000021571. www.anzctr.org.au.