Table 1 Definitions used in assessment

Primary outcome

Primary or main outcomes defined explicitly, or an outcome used in power calculation, or a main outcome described explicitly in primary study objectives

Type of outcome

Primary outcomes where defined were classified as complete healing if primary outcome was proportion healed or time to complete healing; surrogate healing if the primary outcome was any other healing-related outcome; and, non-healing if the primary outcome was a non-healing outcome such as presence of infection or pain.

Sequence generation

Method described for generating the randomisation sequence used to allocate participants to study groups, including computer-generated sequences, random number tables, and coin tosses

Allocation concealment

Method described to prevent the individual responsible for enrolling trial participants from knowing or predicting the allocation sequence in advance, including central randomisation or sealed, opaque, sequentially numbered envelopes

Blinding of assessors

Outcome assessors had no knowledge of the participants’ group allocation or it was judged that the outcome and the outcome measurement was unlikely to be influenced by lack of blinding (for example, mortality).

Overall risk

- Low risk of bias: Study was at low risk of bias in all three domains.

- Unclear risk of bias: Study at unclear risk of bias in one or more domain and at high risk of bias in none.

- High risk of bias: Study was at high risk of bias in one or more domains.