title: Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): a pilot and feasibility randomised controlled trial.
abstract: To establish the feasibility of conducting a definitive randomised controlled trial (RCT) comparing the effectiveness of resuturing versus expectant management for dehisced perineal wounds.
  
  
  
  A multicentre pilot and feasibility RCT.
  
  
  
  Ten UK maternity units from July 2011 to July 2013.
  
  
  
  Eligible women with a dehisced perineal wound within 2 weeks of childbirth.
  
  
  
  The interventions were resuturing or expectancy. Randomisation was via web or telephone, stratified by participating centre. Blinding was not possible due to the nature of the interventions. Analysis was by intention-to-treat.
  
  
  
  The primary outcome measure was wound healing at 6-8 weeks.
  
  
  
  The study revealed a number of feasibility issues, particularly strong patient and clinician preference for treatment options at recruiting centres and the timing of the primary outcome measure. Thirty-four women were randomised (17 in each arm). Data from 33 women were analysed on an intention-to-treat analysis to obtain preliminary estimates of effect size. There was a difference in wound healing at 2 weeks favouring resuturing (OR 20.00, 95% CI 2.04 to 196.37, p=0.004). However, by 6-8 weeks all but one wound in both groups had healed.
  
  
  
  PREVIEW revealed a number of feasibility issues, which impacted on recruitment rate. These will have to be taken into account in the design of any future definitive study. In this feasibility study, resuturing was associated with quicker wound healing and women reported higher satisfaction rates with the outcome at 3 months.
  
  
  
  ISRCTN05754020.
authors.affiliation: The Maternity Centre, Royal Stoke, University Hospitals of North Midlands, Staffordshire, UK.|Faculty of Health, Staffordshire University, Stafford, UK.
authors.forename: L
authors.initials: L
authors.lastname: Dudley
authors.affiliation: Faculty of Health Sciences, Professor Emerita of Women's Health, Staffordshire University, Stafford, UK.
authors.forename: C
authors.initials: C
authors.lastname: Kettle
authors.affiliation: Faculty of Health and Social Sciences, Professor of Health Care Statistics and Epidemiology, Bournemouth University Clinical Research Unit, Bournemouth University, Dorset, UK.
authors.forename: P W
authors.initials: PW
authors.lastname: Thomas
authors.affiliation: Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
authors.forename: K M K
authors.initials: KM
authors.lastname: Ismail
mesh_terms: D000328:Adult; D000072700:Conservative Treatment; D036861:Delivery, Obstetric; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D022125:Lacerations / Q000601:surgery*; D017060:Patient Satisfaction; D010502:Perineum / Q000293:injuries* / Q000601:surgery; D010865:Pilot Projects; D011247:Pregnancy; D013529:Surgical Wound Dehiscence / Q000628:therapy*; D013536:Suture Techniques; D016896:Treatment Outcome; D006113:United Kingdom; D014945:Wound Healing; D055815:Young Adult
keywords: Dehiscence; Expectancy; Perineum; Postnatal; Re-suturing