| Methods |
RCT; participants randomised (> 1 wound per person, all followed)
Funding: non‐industry funding ‐ Jaonbazan Medical and Engineering Research Center (Iranian government body for spinal chord injury war victims). Setting: care home and community with spinal injury
Duration of follow‐up 8 weeks
Unit of analysis: ulcer |
| Participants |
52 participants with pressure ulcers. PU Stage: I (33%; 36%) and II (58%, 64%) (stratified and results separate). Shea I defined as "Limited to epidermis, exposing dermis; includes a red area" (PU classification: Shea).
Age: for all participants (mixed wounds): mean 36.6 (SD 6.0) years ‐ no difference between groups. Duration of ulcer: for all participants (mixed wounds): 7.6 (SD 5.6) weeks, 5.8 (SD 8.0) weeks, 5.3 (SD 5.4) weeks; P > 0.10. Ulcer size: for all participants (mixed wounds): mean 7.26 cm² (SD 15.4), 5.12 cm² (SD 3.63), 10.27 cm² (SD 15.32); P > 0.10.
Wound characteristics at baseline: infection not reported; slough not reported; no wounds necrotic; exudate not reported
Comment: spinal chord injury; all male and young war victims; wounds debrided first if necessary |
| Interventions |
Group 1: hydrogel dressing ‐ hydrocolloid adhesive dressing (description "hydrocolloid adhesive dressings absorb water and low molecular weight components from ulcer secretions, so they swell to produce a jelly"). No concomitant antibiotic, steroid or antisuppressant treatments allowed. No debridement needed during treatment. All other concomitant treatments the same; n = 16. Grouped intervention category: advanced dressing
Group 2: phenytoin topical ‐ phenytoin topical (no concomitant antibiotic, steroid or antisuppressant treatments allowed. No debridement needed during treatment. All other concomitant treatments the same); n = 19. Grouped intervention category: phenytoin topical
Group 3: saline wet ‐ no concomitant antibiotic, steroid or antisuppressant treatments allowed. No debridement needed during treatment. All other concomitant treatments the same (no concomitant antibiotic, steroid or antisuppressant treatments allowed. No debridement needed during treatment. All other concomitant treatments the same; n = 17. Grouped intervention category: basic dressing |
| Outcomes |
Primary outcomes: proportion completely healed at 8 weeks; time to complete healing not reported |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Selection bias |
Low risk |
Sequence generation adequate ‐ random number tables. Allocation concealment adequate ‐ central randomisation with contact details or list held independently. Baseline comparability adequate ‐ no suggestion of problems. Rating: low |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Blinded to interventions (clear description) |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing data: Group 1 ‐ none. Group 2 ‐ none. Group 3 ‐ none
i.e. no missing data (clearly stated) |
| Selective reporting (reporting bias) |
Low risk |
Adequate ‐ full results reported |
| Other bias
unit of analysis |
Unclear risk |
Unit of randomisation person and unit of analysis ulcer ‐ probably participants randomised; if > 1 ulcer then same treatment within participant; < 1.2 ulcer:person = 18/16, 21/19 and 19/17 |
| Other bias
additional |
Low risk |
Adequate ‐ no suggestion of problems |
| ALL‐DOMAIN RISK OF BIAS |
Unclear risk |
Rating: unclear/low
Reasons: unit of analysis issues (small)
Comments: slight unit of analysis issues (but number of ulcers very close to number of participants) |
