| Literature DB >> 26792213 |
Rohin Krishnan1, S Danielle MacNeil1, Monali S Malvankar-Mehta1.
Abstract
OBJECTIVE: To determine whether there still remains a significant advantage in the use of sutures to staples for orthopaedic skin closure in adult patients.Entities:
Mesh:
Year: 2016 PMID: 26792213 PMCID: PMC4735308 DOI: 10.1136/bmjopen-2015-009257
Source DB: PubMed Journal: BMJ Open ISSN: 2044-6055 Impact factor: 2.692
Figure 1PRISMA flow diagram.33
Baseline characteristics
Baseline characteristics of all included studies. All missing information are omitted in black.
ITT: sample size when considering intention to treat.
ORIF, fraction open reduction, internal fixation; PC, prospective cohort; RC, retrospective cohort; RCT, randomised controlled trial; THR, total hip arthroplasty; TKR, total knee arthroplasty.
Critical appraisal of included studies
| Were the patients similar at the start? | |||
|---|---|---|---|
| Study | Randomisation | Allocation concealed | Baseline characteristics similar |
| Stockley and Elson | X | X | ? |
| Clayer and Southwood | X | X | ✓ |
| Liew and Haw | ✓ | ? | ? |
| Graham | ✓ | ? | ? |
| Murphy | ✓ | ? | ? |
| Shetty | ✓ | ✓ | ? |
| Khan | ✓ | ✓ | ✓ |
| Singh | X | X | ✓ |
| Eggers | ✓ | ✓ | ✓ |
| Newman | X | X | ? |
| Patel | X | X | ? |
| Slade Shantz | ✓ | ✓ | ✓ |
| Wyles | ✓ | ✓ | ✓ |
| Stockley and Elson | X | ? | ✓ |
| Clayer and Southwood | X | ✓ | ✓ |
| Liew and Haw | X | X | ? |
| Graham | X | ? | ? |
| Murphy | X | X | X |
| Shetty | X | ✓ | X |
| Khan | ✓ | ✓ | ✓ |
| Singh | X | ✓ | X |
| Eggers | ✓ | ✓ | ✓ |
| Newman | X | ✓ | X |
| Patel | X | ? | X |
| Slade Shantz | ✓ | X | X |
| Wyles | X | ✓ | ✓ |
Critical appraisal assessing treatment randomisation, baseline allocation concealment, baseline characteristics similarity, blinding, follow-up completion and intention-to-treat analysis. Checkmarks indicates the presence of each factor, X's lack thereof, and question marks indicate unclear reporting.
Grade assessment for overall quality of evidence with respect to infection
| Number of participants | Risk of bias | Inconsistency | Indirectness | Imprecision | Publication bias | Overall quality of evidence |
|---|---|---|---|---|---|---|
| Infection (follow-up: range 365 days) | ||||||
| 761 | Serious | Not serious | Not serious | Serious | Publication bias strongly suspected | ⨁◯◯◯ |
| Infection (follow-up: range 365 to) | ||||||
| 484 | Serious | Serious | Not serious | Serious | Publication bias strongly suspected | ⨁◯◯◯ |
GRADE evaluation for overall quality of evidence. Included studies are separated into clinical trials and observational studies. Overall, included studies are of very low quality. Explanations for risk of bias, inconsistency, indirectness, imprecision and publication bias are provided below.
1. Singh et al,8 Newman et al,26 Patel et al29 were observational studies (no randomisation, allocation concealment, blinding).
2. Clayer and Southwood and Stockley et al did not truly randomise (randomised based on unit number and date of birth).
3. Of the randomised trials, six studies did not report or conceal allocation.
4. Of the randomised trials, seven studies did not blind (patient or assessor) to the treatment (staples or sutures).
5. For seven studies, completion of follow-up for all patients was not clearly reported or did not occur.
6. For two studies infection was not the primary outcome.
7. I2 value <75%.
8. All studies included in the meta-analysis directly compare sutures to staples.
9. Very few events occurred in suture and staple treatment arms resulting in very large confidence intervals.
10. One study did not publish results and was excluded from our systematic review/ meta-analysis.
GRADE, Grading of Recommendations, Assessment, Development, and Evaluation; RCT, randomised controlled trial.
Primary and secondary outcomes comparing suture to staples for skin closure after orthopaedic surgery
| Incidence | Heterogeneity | |||||
|---|---|---|---|---|---|---|
| Outcome | Sutures | Staples | Relative risk (95% CI | p Value | I2 (%) | χ2 (p Value) |
| Infection | 17|563 | 21|692 | 1.06 (0.46 to 2.44) | 0.89 | 18 | 0.27 |
| Dehiscence | 6|308 | 21|441 | 0.96 (0.32 to 2.84) | 0.94 | 0 | 0.50 |
| Inflammation | 3|59 | 22|72 | 0.22 (0.00 to 12.07) | 0.46 | 84 | 0.01* |
| Discharge | 8|123 | 17|135 | 0.66 (0.14 to 3.23) | 0.61 | 58 | 0.09 |
| Necrosis | 1|92 | 3|97 | 0.51 (0.07 to 3.88) | 0.52 | 0 | 0.43 |
| Allergic reaction | 2|226 | 1|211 | 1.37 (0.22, 8.60) | 0.74 | 0 | 0.59 |
| Abscess | 2|115 | 2|244 | 1.86 (0.22 to 15.71) | 0.57 | 0 | 0.37 |
| Closure time | Sutures vs staples | 5.84 (4.52 to 7.15) | < 0.001 | 0 | 0.55* | |
Primary and secondary outcomes comparing sutures to staples for skin closure after orthopaedic surgery. All outcomes (95% CI) are calculated using the Mental-Haeszel random-effects model. Heterogeneity is calculated using the I2 statistic. χ2 significance level dictates whether the heterogeneity between studies is significant (*p<0.05).
Figure 2Forest plot of the cumulative risk ratio (95% CI) of wound infection comparing patients who received staples or sutures for wound closure after orthopaedic surgery. Analysis conducted with Mantel-Haenzel random-effects model.
Figure 3Forest plot of the cumulative risk ratio (95% CI) of wound dehiscence comparing patients who received staples or sutures for wound closure after orthopaedic surgery. Analysis conducted with Mantel-Haenszel random effects model.
Sensitivity analysis
| Sensitivity analysis | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Initially randomised | Lost to follow-up | Deaths | Per protocol sample size | Per protocol | Favouring sutures (worst case staples) | Favouring staples (worst case sutures) | |||||
| Study | Sutures | Staples | Sutures | Staples | Sutures | Staples | Sutures | Staples | Relative risk | Relative risk (95% CI) | Relative risk (95% CI) |
| Slade Shantz | 97 | 93 | 28 | 14 | 0 | 0 | 69 | 79 | 1.14 (0.07 to 17.96) | 0.06 (0.01 to 0.47) | 27.80 (3.87 to 200) |
| Liew and Haw | 23 | 23 | 1 | 4 | 2 | 1 | 19 | 18 | 2.85 (0.12 to 65.74) | 0.25 (0.03 to 2.07) | 5.0 (0.25 to 98.75) |
| Shetty | 55 | 55 | 0 | 0 | 8 | 1 | 47 | 54 | 0.10 (0.01 to 1.84) | 0.09 (0.01 to 1.61) (no loss to follow-up) | |
Sensitivity analysis for the relative risk of infection. Adjusted studies were those who did not follow ITT protocol and had lost to follow-up. Adjusted relative risks were calculated for two scenarios. Scenario 1: all lost to follow-up had infection in suture group, and none in staple group. Scenario 2: all lost to follow-up had infection in staple group, and none in the suture group. Original randomised treatment sizes were used for adjusted relative risk calculations.
ITT, intention to treat.
Figure 4Forest plot indicating the adjusted relative risk (RR; 95% CI) of infection within scenario 1: all lost to follow-up had infection in the suture group, thus favouring staples. Original randomised treatment sizes were used for RR calculations. Cumulative effect was calculated using the Mantel-Haenzel random-effects model.
Figure 5Forest plot indicating the adjusted relative risk (RR; 95% CI) of infection within scenario 2: all lost to follow-up had infection in the staple group, thus favouring sutures. Original randomised treatment sizes were used for RR calculations. Cumulative effect was calculated using the Mantel-Haenzel random-effects model.
Figure 6Forest plot indicating relative risk (95% CI) within hip surgeries. Cumulative effect was calculated using the Mantel-Haenzel random-effects model.
Figure 7Forest plot indicating relative risk (95% CI) within knee surgeries. Cumulative effect was calculated using the Mantel-Haenzel random-effects model.
Figure 8Funnel plot examining potential publication bias for incidence of wound infection after orthopaedic surgery (RR, relative risk).