Piaggesi 2001.
| Methods | Single‐centred, 2‐armed RCT comparing a fibrous‐hydrocolloid (hydrofibre) dressing (Aquacel, ConvaTec) with saline moistened gauze undertaken in Italy Duration of follow up: patients were followed until complete re‐epithelialisation occurred. Maximum calculated by review authors as approximately 350 days. | |
| Participants | 20 participants Inclusion criteria: diabetic patients (type 1 or type 2) for over 5 years, between age 18 to 75 years, foot ulcer more than 3 weeks, > 1 cm wide and 1 cm deep, good peripheral blood supply (palpable peripheral pulses or ABPI > 0.9). Ulcers were due to diabetic neuropathy, or surgical drainage of a previous infection or both. Exclusion criteria: active infection documented by clinical local (redness, swelling, tenderness, purulent discharge, odour) or systemic (fever, malaise, leukocytosis) and confirmed with culture exams. Serum creatinine > 2 mg/dl, recent episodes of ketoacidosis, malignancies and any systemic therapy or chronic pathology which could obstruct the healing process. | |
| Interventions | Group A (n = 10): fibrous‐hydrocolloid (hydrofibre) dressing (Aquacel, ConvaTec); dressing changed every second or third day, depending on the extent of wound exudate Group B (n = 10): saline‐moistened gauze; dressing renewed twice a day with saline to prevent drying out Both trial dressings were covered by several layers of gauze Co‐interventions: participants received special postoperative shoes to relieve the pressure from the ulcerated foot. Participants were trained to walk with crutches until there was satisfactory healing. | |
| Outcomes | Primary outcome: ulcer healing (number of ulcers healed; healing time in days; median % reduction in lesion volume; median % of granulation tissue) Secondary outcomes: amputation; adverse events; cost/resource use (average number of days between dressings changes) Health‐related quality of life and ulcer recurrence not reported | |
| Notes | Trial data: Analysis 5.1 Study authors have also reported the results for healing time excluding the patients suffering from infection (NOT extracted) Funding source: grant from Italian health board (Ministero della Sanita: Ricerca Finalizzata 1999 ‐ Convenzione no. RF 99.52). Dressing material and devices were supplied by the hospital during the study as part of the routine therapy: manufacturers were not involved in any part of the experiment. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote:"Patients were randomly sorted into two different groups using a computer ‐generated list". Comment: method of generation of random schedule reported |
| Allocation concealment (selection bias) | Unclear risk | Comment: the process of randomising participants, including who did this is not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: no mention of blinding in study report |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote:"After 8 weeks patients were blindly evaluated by one of the authors (M.R) for rate of RVL and rate of GT". Comment: it is not clear if healing assessment was blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no indication of incomplete outcome data in paper |
| Selective reporting (reporting bias) | Low risk | Comment: based on study report, protocol not obtained |
| Other bias | Low risk | Comment: funded by non‐commercial organisation |
ABPI: ankle brachial pressure index ITT: intention‐to‐treat RCT: randomised controlled trial