Calcium polyuronate dressing supplemented with zinc and manganese (trionic®) in necrotizing dermohypodermitis of the extremities: a randomized multicentre study.

Background. For the burn surgeon, the treatment of necrotizing soft tissue infections is one of the most demanding surgical emergencies, requiring "radical excisions" of the infected tissue and reconstruction. During the infection period, the excised sites are treated with application of gauzes soaked in saline solution. When the septic period is over, the excision sites are usually covered by sterile paraffin gauze dressing. Our aim was to evaluate a new calcium polyuronate dressing enriched with zinc and manganese ions (test group) versus the reference therapeutic combination (control group) from the septic period to the grafting of skin. Materials and methods. A multicentre, prospective, controlled, randomized clinical trial was conducted from November 2003 to July 2005. The primary endpoint was the waiting period for carrying out the skin graft and the percentage of grafted patients at 28 days after the last excision. The secondary endpoints were blood loss, exudates amounts, and pain during dressing changes. Results. Twenty-five patients were included, 14 with the new dressing and 11 with the reference therapeutic combination. The average waiting period for skin graft was 18 days in the test group versus 27.1 days in the control group (p = 0.128). All the patients in the test group received their grafts within 28 days after the last excision, compared with 60% (p = 0.043) in the control group. Bleeding during dressing change was statistically lower in the test group: 45.5% of the patients did not bleed compared with 0% in the control group (p = 0.045). Treatments were well tolerated. Conclusion. The properties of this new calcium polyuronate enriched with zinc and manganese ions seem to accelerate granulation tissue development, allowing skin grafting earlier in favourable conditions with less bleeding and less pain during dressing renewal.

RCT Entities:   Population Interventions Outcomes