Author, date and country | Patient group | Study type (level of evidence) | Outcomes | Key results | Study Weaknesses |
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Luck R et al June 2013 United States | Children 1 to 18 years old, with facial lacerations 1 to 5 cm, were randomized to repair with fast-absorbing catgut (FAC) or nylon (NYL) non-absorbable sutures. Primary objective was to compare the long-term cosmetic outcomes of each based on physician scoring. Secondary objectives include analysis of complication rates and patient/caregiver satisfaction. 98 patients were enrolled and followed up at 4-7 days and 3-4 months. Primary outcome was VAS score calculated by 3-blinded physicians at 3-4 months follow up. A noninferiority (NI) difference of 15 mm with the cosmesis VAS was considered clinically equivalent. Caregivers and patients also did VAS score and completed the survey. | A prospective unblinded, non-inferiority randomised controlled trial conducted at two academic urban paediatric EDs. | Mean physician VAS score for FAC and NYL | VAS for FAC and NYL were 57.6 and 67.6 respectively (difference, -10.0; 95% CI -19.1 to -0.4), thus NI for FAC could not be established. | Only English speaking patients included which decreases its generalisability. No blinding of the patients, parents, clinicians and outcome assessor at first follow up. No intention to treat analysis, which reduces its internal validity. Trial could not achieve the power and large attrition rate, which makes it susceptible to type II error. Limited external validity with large number of exclusion criterias. Failed to achieve the primary outcome and therefore a negative trial. |
Mean caregiver VAS score for FAC and NYL | VAS for FAC and NYL were 93.8 and 86.6 respectively.(difference, 7.2; 95% CI -4.9 to 13.9) thus NI was FAC was established | ||||
Rate of complications | No significant difference between two groups. | ||||
Future suture preference by the caregiver | Caregivers favoured FAC (33/33) over NYL (26/36) (P<0.01) | ||||
Luck PR et al March 2008 USA | ED patients 1-18 years of age with facial lacerations of 1-5cm were randomized to wound closure with either 5–0 or 6-0 fast-absorbing surgical gut (FAC) or Nylon (nonabsorable suture). Primary objective was to demonstrate non-inferiority of absorbable sutures versus non-absorbable sutures as measured by cosmetic outcomes at 3 months. Secondary objectives include comparisons of complication rates and parental and patient satisfaction at 3 months. 88 patients were enrolled and 47 completed the study. Patients followed up at 5-7 days and at 3 months. Primary outcome was VAS score calculated by 3-blinded physicians at 3 months. A VAS score of 15 mm or greater was considered to be minimal clinical important difference (MCID) Parents and adolescents also rated wound using VAS and completed the satisfaction survey. | A prospective unblinded, non-inferiority, randomised controlled single centre trial. | Mean physician VAS score for FAC and NYL | VAS for FAC and NYL were 92.3 (95% CI 89.1 - 95.4) and 93.7 (95% CI 91.4 - 96.0) respectively which was less than the MCID of 15 mm thus NI for FAC was established. | Not all eligible patients were recruited and the allocation process is not very clear. No blinding of the patients, parents, clinicians and outcome assessor to the allocation arm. Limited external validity with large number of exclusion criterias. No intention to treat analysis, which reduces its internal validity. Very high attrition rate without any attempt to identify outliers or bad outcomes, which reduces the internal validity of the trial Trial failed to achieve adequate power so results may not be true. No cost-effectiveness analysis. |
Mean parental VAS score for FAC and NYL | VAS for FAC and NYL were 86.3 (95% CI 78.4 - 94.1) and 91.2 (95% CI 86.9 - 95.4) respectively which was less than the MCID of 15mm and NI was FAC was established | ||||
Rate of complications | No significant difference between the two groups. | ||||
Parental satisfaction | No significant difference between the two groups. | ||||
Karounis H et al July 2004 Canada | ED patients 1-18 years of age with lacerations <12 hours old and requiring sutures were randomized to Group A (absorbable plain catgut sutures) or Group NA (non-absorbable nylon sutures) 95 patients were enrolled. 50 in group A and 45 in group NA Objectives stated were to show that the use of absorbable sutures in pediatric traumatic lacerations affords good long-term cosmesis and no increase in complications when compared with wounds sutured with nonabsorbable sutures. First follow up at 5-10 days by the research nurse and WES score calculated. The primary outcome measure was the previously validated VAS of the wounds at four months after repair and was calculated by a blinded plastic surgeon at 4-5months. | A prospective unblinded randomised controlled single centre trial. | WES score at short term follow up | No difference was found in the proportion of optimal WES scores between group A (63% of patients) and group NA (49% of patients) (relative risk = 0.73; 95% confidence interval [95% CI] = 0.45 to 1.17). | Failure to blind patient, clinician or nurse outcome assessor to allocation arm increases risk of bias. No intention-to-treat statement. No reporting of irrigation methods or prophylactic antibiotic use. No reporting of reasons for excluding subjects. Underpowered for primary outcome (needed 86 to complete follow-up, had 63) and not designed to evaluate therapeutic equivalence. Broad exclusion criterias, which limits the generalizability of the study. |
Average VAS score at four months | Average VAS score at four months was 79 (95% CI = 73 to 85) for group A and 66 (95% CI = 55 to 76) for group NA. | ||||
WES scores at four months | No differences were found in the proportion of optimal WES between group A (36% of patients) and group NA (28% of patients) at four months (relative risk = 0.88; 95% CI = 0.62 to 1.26). | ||||
Rate of complications | No difference was found in the rates of infection and dehiscence between the two groups. | ||||
Holger et al July 2004 United States | Consecutive patients over the age of 5 years presenting between 7:00am and 2:00am with facial lacerations were recruited. 145 patients enrolled. Objective was to compare the 9- to 12-month cosmetic outcome of facial lacerations closed with rapid-absorbing gut suture (RG), octylcyanoacrylate (OC), or nylon suture (NI). First follow up at 4-5 days and wounds were assessed for infection or dehiscence. Primary outcome was the two blinded physicians VACS at 9-12 months months follow up. Study was powered to 90% to detect a minimally clinically important difference (MCID) of 15 mm | A prospective randomised controlled single centre trial. | Reviewer A mean VACS outcome scores at 9 to 12 months | NL (N=28), 77.1 (95% CI 71.0 - 83.2), OC (N=27) 77.2 (95% CI 70.9-83.5), RG (N=29) 73.6 (95% CI 66.8 - 80.4) | Convenience sampling, which can create selection bias. No intention-to-treat statement. No reporting of irrigation methods or prophylactic antibiotic use patterns. Underpowered for primary outcomes (needed 36 per group, but had 27 to 29 per group). Post hoc power analysis still yielded 81% power. Significant difference in two-layered closure in OC group suggesting a possibility of selection bias. |
Reviewer B mean VACS outcome scores at 9 to 12 months | NL (N=28), 88.0 (95% CI 83.0 - 93.1), OC (N=27) 86.0 (95% CI 77.4 - 94.7), RG (N=29) 88.7 (95% CI 85.3 - 92.2) | ||||
Patient mean VAS outcome scores at 9 to 12 months | NL (N=28), 83.2 (95% CI 77.3 - 89.1), OC (N=27) 82.0 (95% CI 75.9 - 88.1), RG (N=29) 79.6 (95% CI 73.1- 86.0) | ||||
Clinically important differences in cosmetic outcome | No clinically important differences in cosmetic outcome among the three closure groups at 9- to 12-month follow up. |