Adhya 2015.
| Methods | Country where data collected: India Parallel‐group RCT (stratified randomisation) Unit of randomisation: participant Unit of analysis: participant Duration: 4 weeks for most outcomes, until epithelialisation for wound healing |
|
| Participants | Inclusion criteria: second‐degree burns, 20% to 60% TBSA Exclusion criteria: superficial (first‐degree) or full‐thickness (third‐degree burns); pregnancy; "significant” comorbidities: pre‐existing heart disease; renal disease; diabetes Participants: 163 hospital patients (unclear if inpatient or outpatient) Mean age (years): 27.4 vs. 31.8 Male participants: 29/52 vs 25/52 Burn type: NR Burn degree and size (%TBSA): mix of 20% ‐40% TBSA (12 vs 15 superficial; 13 vs 17 deep dermal) and > 40%‐60% TBSA (10 vs 6 superficial; 14 vs 14 deep dermal) (also stratified in the analysis) Burn location: NR Note participant characteristic data refers to analysed participants not the total number randomised (substantial difference) |
|
| Interventions | Intervention arm 1: nano‐crystalline silver hydrogel (50 ppm), applied topically on alternate days. N = 52 Intervention arm 2; SSD cream (DISILVA, 1%), applied topically on alternate days. N = 52 Cointerventions: unspecified dressing |
|
| Outcomes | Primary outcome: wound healing ‐ proportion of wounds completely healed by 4 weeks (reported only for deep dermal burns) Primary outcome: wound healing ‐ time (days) to complete wound healing |
|
| Notes | Funding: Department of Science & Technology, West Bengal | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “Simple randomization sequence was generated by computer software” Comment: unclear what “simple” means in this context but computer‐generated randomisation sequences generally regarded as low risk |
| Allocation concealment (selection bias) | Unclear risk | Quote: “After allocation of patients into two different groups, SSD and AgNP gel were administered topically…” Comment: no detail on allocation concealment |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: “this study was designed as an open‐label prospective, parallel group, randomized controlled trial.....Clinical assessments of burn wound were done on every week till 4th week and on completion of treatment.” Comment: open label trial with no mention of blinding assessors |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: “Data for evaluation were obtained for 54 patients on SSD (2° deep‑dermal cases 27) and 52 (2° deep‑dermal cases 31) on AgNP treatment” Comment: 163 randomised, 57 lost to follow‐up. Similar numbers in each arm (30 vs. 27) but no reasons given |
| Selective reporting (reporting bias) | Unclear risk | Quote: “As shown in Table 12, considering deep‑dermal burn wounds only, the differences in treatment outcome at 4 weeks was statistically highly significant (P = 0.003) in favor of AgNP treatment. However, at 4 weeks, only 4 cases in AgNP arm had achieved complete wound healing compared to none in the SSD arm, and this was not a statistically significant difference [Table 13]. However, 25 had achieved 50% wound healing compared to 13 on SSD, and this was statistically significant (P = 0.001).” Comment: proportion of wounds healed completely by 4 weeks given for deep dermal wounds only. No explanation of why analysis would be stratified |
| Other bias | Low risk | Comment: no other issues identified, but reporting insufficient to be certain |