AbstractTo evaluate the effectiveness of a a new cooling device (gel pad) with a standard regimen (ice pack) and compare these with a no localised treatment regimen (control). Design: A randomised controlled trial initially based in hospital and then continued in the community. Setting: A Midwifery Unit in the North of England and then in women's own homes. Participants: 450 women who had undergone either a normal or an instrumental delivery that required suturing of an episiotomy or second degree tear. Key Conclusions: This clinical trial confirms earlier findings in a previous study and provides evidence that the use of a specifically designed cooling gel pad is a safe and effective localised method to alleviate perineal trauma without any adverse effects on healing.