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Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study
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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

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Comparison 1 Topical phenytoin versus hydrocolloid dressing, Outcome 1 Proportion of ulcers healed within trial period.
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Analysis 1.1

Comparison 1 Topical phenytoin versus hydrocolloid dressing, Outcome 1 Proportion of ulcers healed within trial period.

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Comparison 2 Topical phenytoin versus simple dressing, Outcome 1 Proportion of ulcers healed within trial period.
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Analysis 2.1

Comparison 2 Topical phenytoin versus simple dressing, Outcome 1 Proportion of ulcers healed within trial period.

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Summary of findings for the main comparison. Topical phenytoin compared with hydrocolloid dressing for pressure ulcers

Topical phenytoin compared with hydrocolloid dressing for pressure ulcers

Patient or population: people with a pressure ulcer

Settings: family homes or nursing homes

Intervention: topical phenytoin

Comparison: hydrocolloid dressing

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with hydrocolloid dressing

Risk with topical phenytoin

Time to complete healing

See comments

See comments

The study data reported did not provide a suitable representation of the outcome of interest

Proportion of ulcers healed within trial period

(eight weeks)

714 per 1000

393 per 1000 (236 to 657)

RR 0.55 (0.33 to 0.92)

56 (1 study)

⊕⊕⊝⊝
low1

Adverse events

See comments

See comments

Not estimable

84 (2 studies)

No adverse drug reactions or interactions were detected in the included RCTs.

Pain

See comments

See comments

Not

estimable

28 (1 study)

Minimal pain was reported in all groups in one study. Study authors made this statement without any data to support it.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RR: risk ratio; SD: standard deviation

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1. Downgraded two levels: serious limitation (risk of bias), serious imprecision (small number of events )

Figuras y tablas -
Summary of findings for the main comparison. Topical phenytoin compared with hydrocolloid dressing for pressure ulcers
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Summary of findings 2. Topical phenytoin compared with triple antibiotic ointment for pressure ulcers

Topical phenytoin compared with triple antibiotic ointment for pressure ulcers

Patient or population: people with a pressure ulcer

Settings: nursing homes

Intervention: topical phenytoin

Comparison: triple antibiotic ointment

Outcomes

Anticipated absolute effects (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with triple antibiotic ointment

Risk with topical phenytoin

Time to complete healing

See comments

See comments

The study data reported did not provide a suitable representation of the outcome of interest

Proportion of ulcers healed within trial period (eight weeks)

See comments

See comments

This outcome was not reported for this comparison

Adverse events

See comments

See comments

Not estimable

28 (1 study)

No adverse drug reactions or interactions were detected in the included RCT.

Pain

See comments

See comments

Not estimable

28 (1 study)

Minimal pain was reported in all groups in one study. Study authors made this statement without any data to support it.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RR: risk ratio; SD: standard deviation

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Figuras y tablas -
Summary of findings 2. Topical phenytoin compared with triple antibiotic ointment for pressure ulcers
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Summary of findings 3. Topical phenytoin group compared with a simple dressing for pressure ulcers

Topical phenytoin compared with a simple dressing for pressure ulcers

Patient or population: people with a pressure ulcer

Settings: family homes or nursing homes, and a hospital

Intervention: topical phenytoin

Comparison: a simple dressing

Outcomes

Anticipated absolute effects (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with a simple dressing

Risk with topical phenytoin

Time to complete healing

See comments

See comments

This outcome was not reported for this comparison

Proportion of ulcers healed within trial period (eight weeks)

296 per 1000

394 per 1000 (187 to 824)

RR 1.33 (0.63 to 2.78)

55 (1 study)

⊕⊝⊝⊝

very low1

Adverse events

See comments

See comments

Not estimable

81 (2 studies)

No adverse drug reactions or interactions were detected in the included RCTs.

Pain

See comments

See comments

This outcome was not reported for this comparison.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; RR: risk ratio; SD: standard deviation

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1. Downgraded three levels: once for serious limitation (risk of bias), and twice for very serious imprecision (small number of events and a wide confidence interval which includes the possibility of both increased healing and reduced healing)

Figuras y tablas -
Summary of findings 3. Topical phenytoin group compared with a simple dressing for pressure ulcers
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Comparison 1. Topical phenytoin versus hydrocolloid dressing

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of ulcers healed within trial period Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 1. Topical phenytoin versus hydrocolloid dressing
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Comparison 2. Topical phenytoin versus simple dressing

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of ulcers healed within trial period Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 2. Topical phenytoin versus simple dressing
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