Prospective randomized trial of skin closure for pacemaker implantation: absorbable vs. non-absorbable suture : PRO-PACE.

Abstract

Pacemaker implantations have been performed for > 50years, reaching 1.25million implants worldwide per year. Despite this, only few randomized studies exist regarding technical aspects of the implantation procedure-in particular, wound closure. Accordingly, the authors compared absorbable vs. non-absorbable suture regarding wound healing. Consecutive patients scheduled for de novo pacemaker implantation without defibrillation therapy were prospectively randomized into two groups: non-absorbable (Prolene®, Ethicon Inc.) or absorbable suture (Monocryl®, Ethicon Inc.). The wound was systematically assessed for cosmetic outcome at 1day, 6weeks, and 1year post implantation using the patient and observer scar assessment scale (POSAS). Adverse events noted included bleeding, pocket hematoma, infection, suture insufficiency, and revision surgery. Atotal of 114patients (mean age: 79 ± 10years, n = 60 male) were randomized into the two groups. Of these, 105 completed follow-up (lost to follow-up: 7.9%). Groups were comparable for clinical characteristics or use of oral anticoagulants. There was no difference in cosmetic outcome and incidence of adverse events at any follow-up visit. POSAS scores were: 1day: 1.4 ± 0.4 vs. 1.3 ± 0.4, P = 0.44, 6weeks: 1.4 ± 0.6 vs. 1.4 ± 0.7, P = 0.57; 1year: 1.4 ± 1.4 vs. 2.1 ± 3, P = 0.60. No pocket hematoma or infection occurred in either group. No additional surgery was necessary for local findings. Retrospectively, scar development was straight in the Prolene® group and slightly wavy with Monocryl®. Suture material does not influence wound healing as represented by the cosmetic result and the occurrence of adverse events. The choice of suture material used should be left to the physician's discretion.