Skin preparation for preventing infection following caesarean section
Information
- DOI:
- https://doi.org/10.1002/14651858.CD007462.pub5Copy DOI
- Database:
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- Cochrane Database of Systematic Reviews
- Version published:
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- 25 June 2020see what's new
- Type:
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- Intervention
- Stage:
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- Review
- Cochrane Editorial Group:
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Cochrane Pregnancy and Childbirth Group
- Copyright:
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- Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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Authors
Contributions of authors
Diah Hadiati wrote the first draft of the protocol. Detty Nurdiati and Hakimi Mohammad contributed to defining the selection criteria and commented on the draft. All authors contributed to data extraction, preparation of results, and finalisation of the report.
For the 2014 update, Erika Ota prepared the first draft, incorporated the results of the additional new study, and prepared the 'Summary of findings' tables. All authors approved the final version of the update for publication.
For the 2018 update, Diah Hadiati, Mohammad Hakimi, and Detty S Nurdiati incorporated results of additional new studies. Katharina da Silva Lopes extracted data and assessed risk of bias for newly added studies, incorporated the results of the additional studies, and prepared the manuscript. Erika Ota rechecked extracted data and risk of bias assessment, prepared the 'Summary of finding' tables, and edited the review text. All authors approved the final version of the update for publication.
For the 2019 update, Yuko Masuzawa and Katharina da Silva Lopes screened, extracted data and assessed risk of bias for newly added studies. Yuko Masuzawa incorporated the results of the additional studies. Yuko Masuzawa and Katharina da Silva Lopes updated the manuscript. Erika Ota checked the analyses, prepared the 'Summary of finding' tables, and edited the review text. All authors approved the final version of the update for publication.
Sources of support
Internal sources
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Universitas Gadjah Mada, Indonesia
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St.Luke's International University, Japan
External sources
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World Health Organization (WHO) and the UNDP‐UNFPA‐UNICEF‐WHO‐World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Switzerland
This review is supported by funding to Cochrane Pregnancy and Childbirth (University of Liverpool)
Declarations of interest
Diah R Hadiati: Diah Hadiati is a named author on Fahmi 2017, but was not involved in the screening process and 'Risk of bias' assessment.
Mohammad Hakimi: none known.
Detty S Nurdiati: none known.
Erika Ota: none known.
Katharina da Silva Lopes: none known.
Yuko Masuzawa: none known.
Acknowledgements
For the first version of this review, the review authors would like to thank staff from the Australasian Cochrane Centre for technical support during the preparation of the review, and sincerely acknowledge Philippa Middleton and Miranda Cumpston for their supportive advice and comments to improve the review. The Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Indonesia provided support for Diah Hadiati and Detty Nurdiati to travel to Australia to finish the first version of this review.
Diah Hadiati wrote the protocol as a part of a SEA‐ORCHID Project Fellowship at the Australasian Cochrane Centre, and wishes to acknowledge the support provided by Steve McDonald and Tari Turner.
For the 2014 update, Erika Ota's work was financially supported by the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development, and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), World Health Organization. The named authors alone are responsible for the views expressed in this publication.
This project was supported by the National Institute for Health Research (NIHR), via Cochrane Infrastructure funding to Cochrane Pregnancy and Childbirth. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Evidence Synthesis Programme, the NIHR, National Health Service (NHS) or the Department of Health and Social Care.
This review is supported by funding from the World Health Organization (WHO) and the UNDP‐UNFPA‐UNICEF‐WHO‐World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) to Cochrane Pregnancy and Childbirth (University of Liverpool). HRP supports and coordinates research on a global scale, synthesizes research through systematic reviews of literature, builds research capacity in low‐income countries and develops dissemination tools to make efficient use of ever‐increasing research information. In addition to its cosponsors, the International Planned Parenthood Federation (IPPF) and UNAIDS are both members of HRP’s governing body.
Version history
| Published | Title | Stage | Authors | Version |
| 2020 Jun 25 | Skin preparation for preventing infection following caesarean section | Review | Diah R Hadiati, Mohammad Hakimi, Detty S Nurdiati, Yuko Masuzawa, Katharina da Silva Lopes, Erika Ota | |
| 2018 Oct 22 | Skin preparation for preventing infection following caesarean section | Review | Diah R Hadiati, Mohammad Hakimi, Detty S Nurdiati, Katharina da Silva Lopes, Erika Ota | |
| 2014 Sep 17 | Skin preparation for preventing infection following caesarean section | Review | Diah R Hadiati, Mohammad Hakimi, Detty S Nurdiati, Erika Ota | |
| 2012 Sep 12 | Skin preparation for preventing infection following caesarean section | Review | Diah R Hadiati, Mohammad Hakimi, Detty S Nurdiati | |
| 2008 Oct 08 | Skin preparation for preventing infection following caesarean section | Protocol | Diah R Hadiati, Mohammad Hakimi, Detty S Nurdiati | |
Differences between protocol and review
The methods have been updated to reflect the latest Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011), and Cochrane Pregnancy and Childbirth's methodological guidelines. We added two secondary outcomes; reduction of skin bacteria colony counts and adverse effects. We used GRADE to assess the certainty of the evidence and included 'Summary of findings' tables.
In the 2018 update, we added a co‐author (Katharina da Silva Lopes). We also added a search of ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP).
We also assessed the certainty of the evidence for two new outcomes, using GRADE criteria.
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Length of stay
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Adverse events (maternal or neonatal)
We assessed the certainty of the evidence, and added the two outcomes to the 'Summary of findings' table because length of stay indicates the severity of the infection, which prolongs the hospital stay after caesarean section, and adverse events are important outcomes for women's decision making.
In this update, we provided additional information about the included studies: trial dates, sources of trial funding, and trial authors' declarations of interest.
In the 2019 update, we added a co‐author (Yuko Masuzawa).
We also added a post hoc subgroup analysis:
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To assess the effect of the addition of alcohol to povidone iodine we performed a post hoc subgroup analysis comparing 'chlorhexidine plus alcohol versus povidone iodine plus alcohol' versus 'chlorhexidine plus alcohol versus povidone iodine alone' in comparison 2, Analysis 2.1. We added this subgroup in response to a query from the guideline development team at the World Heatlh Organization (WHO).
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
- Anti-Infective Agents, Local [adverse effects, *therapeutic use];
- Bandages;
- Cesarean Section [*adverse effects];
- Chlorhexidine [adverse effects, analogs & derivatives, therapeutic use];
- Endometritis [epidemiology, *prevention & control];
- Ethanol [therapeutic use];
- Iodine [therapeutic use];
- Iodophors [therapeutic use];
- Length of Stay;
- Povidone-Iodine [adverse effects, therapeutic use];
- Preoperative Care [*methods];
- Randomized Controlled Trials as Topic;
- *Surgical Drapes;
- Surgical Wound Infection [epidemiology, *prevention & control];
- Xylenes [therapeutic use];
Medical Subject Headings Check Words
Adult; Female; Humans; Pregnancy;
PICOs
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
'Risk of bias' graph: review authors' judgements about each risk of bias item for each included study
Comparison 1: Parachlorometaxylenol with iodine versus iodine alone, Outcome 1: Surgical site infection
Comparison 1: Parachlorometaxylenol with iodine versus iodine alone, Outcome 2: Endometritis
Comparison 2: Chlorhexidine gluconate versus povidone iodine, Outcome 1: Surgical site infection
Comparison 2: Chlorhexidine gluconate versus povidone iodine, Outcome 2: Endometritis
Comparison 2: Chlorhexidine gluconate versus povidone iodine, Outcome 3: Re‐admission resulting from infection
Comparison 2: Chlorhexidine gluconate versus povidone iodine, Outcome 4: Bacterial growth 18 hours
Comparison 2: Chlorhexidine gluconate versus povidone iodine, Outcome 5: Adverse events (maternal)
Comparison 3: Drape versus no drape, Outcome 1: Surgical site infection
Comparison 3: Drape versus no drape, Outcome 2: Metritis
Comparison 3: Drape versus no drape, Outcome 3: Length of stay
Comparison 3: Drape versus no drape, Outcome 4: Reduction of skin bacteria colony counts
| Parachlorometaxylenol with iodine versus iodine alone | ||||||
|---|---|---|---|---|---|---|
| Population: women undergoing caesarean section Comparison: iodine alone | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of participants | Certainty of the evidence | Comments | |
| Risk with iodine alone | Risk with parachlorometaxylenol with iodine | |||||
| Surgical site infection | Study population | RR 0.33 | 50 | ⊕⊝⊝⊝ | ||
| 120 per 1000 | 40 per 1000 | |||||
| Endometritis | Study population | RR 0.88 | 50 | ⊕⊝⊝⊝ | ||
| 640 per 1000 | 563 per 1000 | |||||
| Length of stay | ‐ | ‐ | ‐ | ‐ | ‐ | This outcome was not reported in the included study. |
| Adverse events (maternal or neonatal) | ‐ | ‐ | ‐ | ‐ | ‐ | This outcome was not reported in the included study. |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| a Wide confidence interval crossing the line of no effect, single study with small sample size (imprecision ‐2). b Blinding of outcome assessor was at high risk of bias (risk of bias ‐1). | ||||||
| Chlorhexidine gluconate compared to povidone iodine | ||||||
|---|---|---|---|---|---|---|
| Population: women undergoing caesarean section Comparison: povidone iodine | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | No of participants | Certainty of the evidence | Comments | |
| Risk with povidone iodine | Risk with chlorhexidine gluconate | |||||
| Surgical site infection | Study population | RR 0.72 | 4323 | ⊕⊕⊕⊝ | ||
| 75 per 1000 | 54 per 1000 | |||||
| Endometritis | Study population | RR 0.95 | 2484 | ⊕⊕⊝⊝ | ||
| 14 per 1000 | 13 per 1000 | |||||
| Length of stay | ‐ | ‐ | ‐ | ‐ | ‐ | This outcome was not reported in any of the included studies. |
| Adverse events (maternal) ‐ skin irritation or allergic skin reaction | Study population | RR 0.64 | 1926 | ⊕⊝⊝⊝ | No neonatal adverse events were reported in any of the included studies. | |
| 15 per 1000 | 9 per 1000 | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| a Selection bias was unclear and blinding of outcome assessor was high risk of bias (risk of bias ‐1). b Wide confidence interval crossing the line of no effect (imprecision ‐1). c Wide confidence interval crossing the line of no effect and few events (imprecision ‐2). | ||||||
| Drape compared to no drape | ||||||
|---|---|---|---|---|---|---|
| Population: women undergoing caesarean section Comparison: no drape | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | No of participants | Certainty of the evidence | Comments | |
| Risk with no drape | Risk with drape | |||||
| Surgical site infection | Study population | RR 1.29 | 1373 | ⊕⊕⊝⊝ | ||
| 112 per 1000 | 144 per 1000 | |||||
| Metritis | 49 per 1000 | 79 per 1000 (14 to 447) | RR 1.62 (0.29 to 9.16) | 79 | ⊕⊝⊝⊝ VERY LOW a,c | |
| Length of stay (days) | The mean length of stay with no drape was 5.7 days | The mean number of days with a drape was 0.10 higher | ‐ | 603 | ⊕⊕⊕⊝ | |
| Adverse events (maternal or neonatal) | ‐ | ‐ | ‐ | ‐ | ‐ | This outcome was not reported in any of the included studies. |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| a Selection bias was unclear and blinding of outcome assessor was at high risk of bias (risk of bias ‐1). b Wide 95% CI (imprecision ‐1). c Single study with small sample size and wide 95% CI (imprecision ‐2). | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Surgical site infection Show forest plot | 1 | 50 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.33 [0.04, 2.99] |
| 1.2 Endometritis Show forest plot | 1 | 50 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.88 [0.56, 1.38] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Surgical site infection Show forest plot | 8 | 4323 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.72 [0.58, 0.91] |
| 2.1.1 Chlorhexidine plus alcohol versus povidone iodine plus alcohol | 4 | 2663 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.62 [0.45, 0.87] |
| 2.1.2 Chlorhexidine plus alcohol versus povidone iodine | 4 | 1660 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.84 [0.61, 1.15] |
| 2.2 Endometritis Show forest plot | 3 | 2484 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.95 [0.49, 1.86] |
| 2.3 Re‐admission resulting from infection Show forest plot | 3 | 2484 | Risk Ratio (M‐H, Random, 95% CI) | 0.51 [0.25, 1.02] |
| 2.4 Bacterial growth 18 hours Show forest plot | 1 | 60 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.23 [0.07, 0.70] |
| 2.5 Adverse events (maternal) Show forest plot | 3 | Risk Ratio (M‐H, Fixed, 95% CI) | Subtotals only | |
| 2.5.1 Any skin reaction | 1 | 374 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.79 [0.32, 1.96] |
| 2.5.2 Erythema | 2 | 1521 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.13 [0.57, 2.26] |
| 2.5.3 Skin irritation or allergic skin reaction | 3 | 1926 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.64 [0.28, 1.46] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Surgical site infection Show forest plot | 3 | 1373 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.29 [0.97, 1.71] |
| 3.1.1 Iodine | 1 | 691 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.42 [0.98, 2.04] |
| 3.1.2 Chlorhexidine | 1 | 603 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.11 [0.70, 1.76] |
| 3.1.3 Isopropyl alcohol scrub versus iodophor scrub | 1 | 79 | Risk Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 3.2 Metritis Show forest plot | 1 | 79 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.62 [0.29, 9.16] |
| 3.3 Length of stay Show forest plot | 1 | 603 | Mean Difference (IV, Fixed, 95% CI) | 0.10 [‐0.27, 0.46] |
| 3.4 Reduction of skin bacteria colony counts Show forest plot | 1 | 79 | Mean Difference (IV, Fixed, 95% CI) | 0.07 [‐0.34, 0.48] |
