La Grenade 1993.

Methods	Desing trial: parallel (3 groups). Study phase: not described. Baseline observation period: 3 months. Follow‐up period: 12 weeks. Randomisation unit: ulcers. Unit of analysis: ulcers. Intention to treat: unclear.
Participants	Sample size: 32 participants. Randomised leg ulcers: 49 (Solcoseryl® 14; hydrocolloid dressing 14; placebo 21). Loss patients reported: 14 (Solcoseryl® 4; hydrocolloid dressing: 8; placebo: 2). (Dr. Graham Serjeant, interviewed by one author of this review (JKM), on February 4, 2011). 16 (Solcoseryl®: 3); hydrocolloid dressing: 8); (Placebo: 5) Loss (%): 50%. Age: Mean (± SD): Solcoseryl®: 27.0 years (8.2); hydrocolloid dressing: 35.5 years (9.8); placebo: 30.7(8.2). Gender (males): Solcoseryl®: 93%; hydrocolloid dressing: 50%; placebo: 71%. Inclusion criteria: 1. Patients with Hb SS. 2. Age (years): ≥ 15 3. Leg ulcer duration: ≥ 16 months. 4. Ulcer size: ≥3 cm. 5. Patients attending for a 3‐month baseline observation period. Exclusion criteria: not described.
Interventions	1. Solcoseryl® (de‐proteinized extract of calf blood) supplied in tubes as jelIy or ointment, twice daily after cleaning with Eusol, covered with a gauze dressing and supported by an Elastoweb bandage. 2. Hydrocolloid dressing (hydroactive dressing) supplied as sheets of occlusive dressing and as granules. and covered with gauze and supported by an Elastoweb bandage. The dressing was replaced at weekly intervals or more often if indicated. Control: Twice‐daily cleaning with a mild antiseptic agent (Eusol), wet dressing and a firm supportive elastic bandage.
Outcomes	Healing ulcer. According with Dr Graham Serjeant, interviewed by one author of this review (JKM), 'ulcer area‐change' was the primary outcome (February 4, 2011).
Notes	Centre and Country: Sickle‐cell Clinic of the University Hospital of the West Indies, Kingston, Jamaica. Solcoseryl® was supplied by Solco Basle Ltd. Hydrocolloid dressing by Convatec. Sample size estimation a priori: no described.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Unilateral ulcers were randomized into one of three treatment schedules in blocks of three" and "In bilateral ulcers, one leg was randomized to one of the two treatment agents and the other leg to control therapy" (page 121). Insufficient information about the sequence generation process to permit judgement of ‘low risk’ or ‘high risk’.
Allocation concealment (selection bias)	Unclear risk	Insufficient information to permit judgement of ‘low risk’ or ‘high risk’.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Insufficient information to permit judgement of ‘low risk’ or ‘high risk’
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information to permit judgement of ‘low risk’ or ‘high risk’
Incomplete outcome data (attrition bias) All outcomes	High risk	Dropouts: 50% (16/32) (Placebo 24% (5/21); Solcoseryl® 21.4% (3/14); hydrocolloid dressing 57.1% (8/14). Reasons: none described. Imbalance between hydrocolloid dressing group and the other groups > 10%.
Selective reporting (reporting bias)	High risk	1 or more clinically relevant and reasonably expected outcomes were not reported on; data on these outcomes were likely to have been recorded (i.e. safety).
Other bias	High risk	Ascertaiment and design bias and bias in the presentation of data (Appendix 2). Comments: there is imbalance in sex and age.