Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): A pilot and feasibility randomised controlled trial.

Dudley, L., Kettle, C., Thomas, P. and Ismail, K.M.K., 2017. Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): A pilot and feasibility randomised controlled trial. BMJ Open, 7 (2), e012766.

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DOI: 10.1136/bmjopen-2016-012766

Abstract

Objective: To establish the feasibility of conducting a definitive randomised controlled trial (RCT) comparing the effectiveness of resuturing versus expectant management for dehisced perineal wounds. Design: A multicentre pilot and feasibility RCT. Setting Ten UK maternity units from July 2011 to July 2013. Population: Eligible women with a dehisced perineal wound within 2 weeks of childbirth. Methods: 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. Outcome: The primary outcome measure was wound healing at 6-8 weeks. Results: 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. Conclusions: 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.

Item Type:Article
ISSN:2044-6055
Additional Information:PREVIEW was funded by the National Institute for Health Research, Research for Patient Benefit (RfPB) (PB-PG-090920079) and sponsored by the Royal Stoke University Hospital. The trial coordinator (LD) also received a doctoral nursing studentship award from the Smith and Nephew Foundation/Research into Ageing (RIA) Age Concern (2008–2011)
Group:Faculty of Health & Social Sciences
ID Code:27479
Deposited By: Unnamed user with email symplectic@symplectic
Deposited On:01 Mar 2017 13:04
Last Modified:01 Mar 2017 13:04

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