Jenkins 2014.

Methods	RCT, single‐centre, hospital emergency department, Northern Ireland
Participants	110 (54 topical anaesthetic putty, 56 lidocaine infiltration), median age (range): infiltration 35 (18‐84), topical anaesthetic putty 35 (20‐81) Male: 94 (85.5%), female: 16 (14.5%). Topical anaesthetic putty group had 10 F, 44 M; lidocaine infiltration group had 6 F, 50 M. Wounds: < 8 cm long and needing suturing or stapling
Interventions	1. Topical anaesthetic putty (containing 4.94% w/w lidocaine hydrochloride, equivalent to 4% w/w lidocaine base) 2. Lidocaine infiltration (1% w/v)
Outcomes	Primary outcomes: Participant‐reported 0‐10 VAS during sensory testing with a 21‐gauge needle “directly after treatment”. Mean pain score was 0.78 + 1.12 (SD) after lidocaine infiltration, 1.49 + 1.76 after topical anaesthetic putty. Overlapping 1‐sided 95% CI limits plus (because data were not normally distributed) non‐parametric contrasting of median scores; both showed non‐inferiority of topical anaesthetic putty c/w infiltrated lidocaine Secondary outcomes: Need for rescue anaesthesia (required by 3 in infiltration group and 4 in topical anaesthetic putty group), “wound evaluation score” obtained 7‐10 days after treatment (12 in topical anaesthetic putty group had less than perfect scores vs 5 in infiltration group), presence of wound infection (4 in infiltration group vs 2 in topical anaesthetic putty group), dehiscence (2 in topical anaesthetic putty group) and adverse effects (1 inflamed wound in topical anaesthetic putty group, 1 required resuturing in each group) No anaesthetic toxicity reported
Intervention dates	Not reported
Declaration of interest	The wound putty used in this study was not a proprietary product and was not produced commercially. The putty was manufactured by 2 of the study authors ‐ Drs. Murphy and McCarron. After the success of this trial, Drs. Jenkins and McCarron sought to protect certain aspects of the putty formulation in both the United States and Europe. This patent application was pending at the time of publication and was related to a certain aspect of the formulation that enables lidocaine to be included. The authors of this study received no funding from commercial sources to support the study. Funding for this study was obtained through a peer‐reviewed competitive process from the Public Health Agency in Northern Ireland. Drs. Jenkins and McCarron were pursuing sources of capital to commercialise the putty but had not yet secured this funding.
Notes	Sourse of funding: supported by the Research and Development Office (Northern Ireland) Trauma and Rehabilitation Recognised Research Group (RRG 8.46 RRG/3273/06) Rescue medication: no systemic anaesthesia or analgesia mentioned. However, “The decision to offer or use rescue anaesthesia rested with the treating investigator”. Rescue = wound margin infiltration with a further dose of 1% lidocaine for the 7 (4 in the topical anaesthetic putty group, 3 in the lidocaine infiltration group) who received it
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomization sequence generated by Microsoft Excel version 14.3.9 through a permuted block randomization technique, with a block size of 8
Allocation concealment (selection bias)	Low risk	Randomization sequence provided in opaque, serially numbered envelopes
Blinding (performance bias and detection bias) All outcomes	High risk	Open label Quote: “Because of the nature of the treatment, it was not feasible to blind either the participants or the investigators to the treatment received". [Extractor’s note: not necessarily true, could have used placebo infiltration and placebo topical putty]
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants completed the first, acute part of the study; 19 did not complete the follow‐up wound assessment.
selective reporting of outcomes All outcomes	Low risk	All outcome‐related data collected during the acute phase were complete.
Other bias (sample size)	Unclear risk	54 topical anaesthetic putty 56 lidocaine infiltration