The Journal of bone and joint surgery. American volume · 2023
Primary Closure or Secondary Wound Healing of Pin Sites After External Fixator Removal: A Single-Center Blinded Randomized Controlled Trial.
Рандомизированное исследованиеСтатьяEquivalence TrialНазвание и аннотация: Перевод в очереди
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Tillmann Franz, Hoepelman Ruben J, Cagienard Flavio, Link Björn-Christian, Babst Reto, van de Wall Bryan J M, Beeres Frank J P
Аннотация
BACKGROUND: The aim of this single-center randomized controlled trial was to compare primary wound closure using a suture with secondary wound healing of pin sites after removal of temporary external fixation.
METHODS: This noninferiority trial included all patients who were treated with a temporary external fixator on an upper or lower extremity at 1 institution. The primary outcome was pin-site infection. Secondary outcomes were measured at 2, 6, 12, 24, and 52 weeks and included all other complications, time to pin-site wound healing (in weeks), the most satisfactory pin site as rated by the patient, the visual analog scale (VAS) score for pain, and the Vancouver Scar Scale (VSS). The most proximal pin site was randomly allocated (1:1) to either primary closure or secondary wound healing, and the other pin sites were treated alternately.
RESULTS: Seventy patients, providing 241 pin sites, were included between January 1, 2019, and March 1, 2020. A total of 123 pin sites were treated with primary closure and 118, with secondary wound healing. The median age was 55 years (interquartile range, 46 to 67 years), 44% were male, and the median duration of the external fixation was 6 days (interquartile range, 4 to 8 days). There were no pin-site infections in either group. Wound healing was significantly faster in the primary closure group (median of 2 versus 6 weeks, p = 0.013). The VSS and patient satisfaction showed no differences between groups. There was 1 case of fracture-related infection not related to any pin site.
CONCLUSIONS: Primary closure of temporary external fixator pin sites did not result in higher infection rates compared with secondary wound healing, and pin sites healed significantly faster after primary closure. Primary closure should therefore be considered in patients treated with a temporary external fixator.
LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.
METHODS: This noninferiority trial included all patients who were treated with a temporary external fixator on an upper or lower extremity at 1 institution. The primary outcome was pin-site infection. Secondary outcomes were measured at 2, 6, 12, 24, and 52 weeks and included all other complications, time to pin-site wound healing (in weeks), the most satisfactory pin site as rated by the patient, the visual analog scale (VAS) score for pain, and the Vancouver Scar Scale (VSS). The most proximal pin site was randomly allocated (1:1) to either primary closure or secondary wound healing, and the other pin sites were treated alternately.
RESULTS: Seventy patients, providing 241 pin sites, were included between January 1, 2019, and March 1, 2020. A total of 123 pin sites were treated with primary closure and 118, with secondary wound healing. The median age was 55 years (interquartile range, 46 to 67 years), 44% were male, and the median duration of the external fixation was 6 days (interquartile range, 4 to 8 days). There were no pin-site infections in either group. Wound healing was significantly faster in the primary closure group (median of 2 versus 6 weeks, p = 0.013). The VSS and patient satisfaction showed no differences between groups. There was 1 case of fracture-related infection not related to any pin site.
CONCLUSIONS: Primary closure of temporary external fixator pin sites did not result in higher infection rates compared with secondary wound healing, and pin sites healed significantly faster after primary closure. Primary closure should therefore be considered in patients treated with a temporary external fixator.
LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.