The MOVE-trial: Monocryl® vs. Vicryl Rapide™ for skin repair in mediolateral episiotomies: a randomized controlled trial.

ABSTRACT

BACKGROUND: Previous studies have shown that complaints after episiotomy repair depend on the method and material used for repair. The objective of our study was to determine which of two frequently used suture materials, Monocryl® (poliglecaprone 25) and Vicryl Rapide™ (polyglactin 910), is superior for intracutaneous closure of the skin in mediolateral episiotomies. METHODS: In a randomized controlled trial performed in a teaching hospital in the Netherlands between 2010 and 2013 250 primiparous women with uncomplicated mediolateral episiotomies were randomly allocated to intracutaneous skin closure with either Monocryl® or Vicryl Rapide™. All other layers were sutured with Vicryl 2-0 and Vicryl 0 in both groups. Pain scores and complications were documented using questionnaires during the first three months post partum. The primary outcome was pain 10 days after delivery in sitting position established by Visual Analogous Scale (VAS). Secondary outcomes were pain scores at different time points and reported complications such as infections, dehiscence and dyspareunia one day, 10 days, six weeks and three months after delivery. RESULTS: Of 250 allocated women 54% returned questionnaires. No statistical difference was found between both groups for the primary outcome (VAS 2,8 (95% CI 2,18-3,44) vs. VAS 2,5 (95% CI 2,00-2,98), p = 0,43). With regard to secondary outcomes only self-reported dehiscence was significantly different, favouring Monocryl® (10% vs. 25%, p = 0.016). CONCLUSIONS: Use of Monocryl® 3-0 and Vicryl Rapide™ 3-0 for intracutaneous closure of the skin after mediolateral episiotomy leads to equal pain scores ten days after delivery and therefore both materials may be considered for this use. Monocryl® 3-0 might be favourable over Vicryl Rapide™ 3-0 due to less self-reported dehiscence after intracutaneous closure of the skin in mediolateral episiotomies. TRIAL REGISTRATION The trial was retrospectively registered under trial nr. ISRCTN29869308 on 20-04-2016.