Randomised control trial
Karounis H, Gouin S, Eisman H, Chalut D, Pelletier H and Williams B.A Randomized, Controlled Trial Comparing Long-term Cosmetic Outcomes of Traumatic Pediatric Lacerations Repaired with Absorbable Plain Gut Versus Nonabsorbable Nylon Sutures
Academic Emergency Medicine Journal
July 2004; 730-735
- Submitted by:Robert Evans - Physician
- Institution:Grand Rapids Medical Research Center - MSU
- Date submitted:7th April 2005
1
Objectives and hypotheses
1.1
Are the objectives of the study clearly stated?
Yes
2
Design
2.1
Is the study design suitable for the objectives
Yes. Prospective, randomized controlled trial.
2.2
Who / what was studied?
In pediatric patients with traumatic lacerations the long term cosmesis and complications with absorbable compared to non-absorbable sutures.
2.3
Was this the right sample to answer the objectives?
Yes
2.4
Is the study large enough to achieve its objectives? Have sample size estimates been performed?
For the initial assessment, the sample size was adequate. For the primary outcome, which was long-term evaluation, the sample size was not adequate, due to patients lost to follow-up. Sample size estimates were performed.
2.5
Were all subjects accounted for?
No. 34% of patients were lost to follow-up.
2.6
Were all appropriate outcomes considered?
Yes.
2.7
Has ethical approval been obtained if appropriate?
Yes.
2.8
Were the patients randomised between treatments?
Yes.
2.9
How was randomisation carried out?
Block numbers of six.
2.10
Are the outcomes clinically relevant?
Yes.
3
Measurement and observation
3.1
Is it clear what was measured, how it was measured and what the outcomes were?
Yes.
3.2
Are the measurements valid?
Yes. A visual analog scale and a wound evaluation score that had both been previously validated were used.
3.3
Are the measurements reliable?
Yes.
3.4
Are the measurements reproducible?
This is unknown, since the patients were only evaluated by one person at each stage.
3.5
Were the patients and the investigators blinded?
It was impossible to blind the treating physician and the patients as well as the nurse evaluating the patients while the sutures were still in place. The physician who evaluated the wound once the sutures were removed was blinded.
4
Presentation of results
4.1
Are the basic data adequately described?
Yes.
4.2
Were groups comparable at baseline?
Yes. Table 1.
4.3
Are the results presented clearly, objectively and in sufficient detail to enable readers to make their own judgement?
Yes.
4.4
Are the results internally consistent, i.e. do the numbers add up properly?
Yes.
4.5
Were side effects reported?
There were no differences between patients with absorbable sutures and those with non-absorbable suture for the rates of dehiscence (2% vs 11%; p=0.07) and infection (0% vs. 2%; p=0.3). Surgical scar revision was recommended for only three patients: two had absorbable sutures and one had non-absorbable.
5
Analysis
5.1
Are the data suitable for analysis?
Yes.
5.2
Are the methods appropriate to the data?
Yes.
5.3
Are any statistics correctly performed and interpreted?
Yes.
6
Discussion
6.1
Are the results discussed in relation to existing knowledge on the subject and study objectives?
Yes.
6.2
Is the discussion biased?
No. Study limitations were addressed in the discussion.
7
Interpretation
7.1
Are the authors' conclusions justified by the data?
Yes.
7.2
What level of evidence has this paper presented? (using CEBM levels)
1b.
7.3
Does this paper help me answer my problem?
Yes.
8
Implementation
8.1
Can any necessary change be implemented in practice?
Yes. I think if it is explained to parents that there is data suggestive that absorbable sutures have similar rates of complications, to non-absorbable sutures but it is not proven, the parents could be left to make the decision.
8.2
What aids to implementation exist?
Simple plain gut sutures are inexpensive, require no additional training to use, and are available in all emergency departments. In addition, the costs associated with suture removal can be avoided.
8.3
What barriers to implementation exist?
Some individuals may still believe that non-absorbable sutures result in fewer wound complications. There is no strong evidence to support this.