Re-stitching of a broken down perineal wound compared to leaving it to heal naturally
| ISRCTN | ISRCTN05754020 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05754020 |
| Secondary identifying numbers | 9098 |
- Submission date
- 08/12/2008
- Registration date
- 16/01/2009
- Last edited
- 20/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Lynn Dudley
Scientific
Scientific
University Hospital of North Staffordshire NHS Trust
Treatment Centre, Children's Services and Obstetrics
Academic Unit of Obstetrics and Gynaecology
Maternity Building, City General Site
Newcastle Road
Stoke-on-Trent
Staffordshire
ST4 6QG
United Kingdom
| Phone | +44 (0)1782 552 058/434 |
|---|---|
| lynn.dudley@uhns.nhs.uk |
Study information
| Study design | Computer-randomised controlled feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Perineal REpair following Vaginal delivery complicated by an Infected Episiotomy Wound: a feasibility study for a randomised controlled trial |
| Study acronym | PREVIEW |
| Study objectives | Many women will require suturing to facilitate healing of the trauma site. However, practice varies widely between care given and established professionally agreed standards. There is limited data on the prevalence and consequences of perineal wound infection. In addition, there is only a small amount of information relating to the impact that perineal wound infection has on women's well-being during the immediate and long-term post-natal period. Anecdotal evidence suggests the number of women reporting perineal infections and dehiscence in the community is increasing; however, systems to track these complications following hospital discharge are lacking. Given that postpartum management of perineal trauma is a core component of routine maternity care it is vital that a true estimate of the problem is established using standardised definitions of wound infection and at the same time determine best practice when treating dehisced perineal wounds. Hypotheses: 1. What is the prevalence of perineal wound infection and dehiscence in the UK? 2. What factors at the time of primary repair are most likely to be associated with perineal wound infection and dehiscence prior to discharge to the community? 3. What factors following discharge home are most likely to be associated with perineal wound infection and dehiscence in the community? 4. What are women's experiences of perineal infection and dehiscence and what types of information and support are most likely to benefit their post-natal recovery? 5. What is the best management for perineal wound infection and wound dehiscence? 6. What is the feasibility of conducting a definitive randomised controlled trial (RCT) comparing re-suturing of dehisced perineal wounds versus healing by secondary intention and what are the implications in terms of health benefits and costs? |
| Ethics approval(s) | North Wales Research Ethics Committee, 29/04/2010, ref: 10/WNO03/16 |
| Health condition(s) or problem(s) studied | Dehisced perineal wounds |
| Intervention | The participants will be computer randomised into either immediate resuturing of their dehisced perineal wound in comparison to healing by secondary intention. Both groups will have an independent assessment of their perineal wound at 2 weeks and 6 weeks after trial entry. Both groups of participants will be asked to complete a questionnaire at 6 weeks, 3 months and 6 months after trial entry. |
| Intervention type | Other |
| Primary outcome measure | Time taken for the dehisced perineal wound to heal, assessed at 2 weeks, 6 weeks, 3 months and 6 months, respectively. An independent assessment of the primary outcome will be conducted at 2 weeks and 6 weeks using a questionnaire format, the title of the questionnaire being: 'PREVIEW' Independent Perineal Assessment 2 weeks, and 'PREVIEW' Independent Assessment 6 weeks Mothers will also complete questionnaires at 6 weeks, 3 months and 6 months, respectively, also assessing primary and secondary outcomes, the title of these questionnaires being: 'PREVIEW' Mothers questionnaire 6 weeks 'PREVIEW' Mothers questionnaire 3 months 'PREVIEW' Mothers questionnaire 6 months |
| Secondary outcome measures | 1. Woman's satisfaction with aesthetic results of perineal wound at 6 months post-natal 2. Pain at 6 weeks, 3 and 6 months post-natal 3. Dyspareunia (painful intercourse) at 3 - 6 months 4. Rates of breastfeeding Mothers will complete questionnaires at 6 weeks, 3 months and 6 months respectively, assessing primary and secondary outcomes, the title of these questionnaires being: 'PREVIEW' Mothers questionnaire 6 weeks 'PREVIEW' Mothers questionnaire 3 months 'PREVIEW' Mothers questionnaire 6 months |
| Overall study start date | 01/04/2009 |
| Completion date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target number of participants | Approximately 250 patients |
| Key inclusion criteria | 1. Women (aged 18 - 40 years) referred to the perineal care clinic at the University Hospital of North Staffordshire 2. Dehisced perineal wound (spontaneous second, third or fourth tear or episiotomy) 3. Occurs within two weeks following childbirth |
| Key exclusion criteria | 1. Women that have not given their written consent to participate in the study 2. Women who have delivered a stillborn infant 3. Women under the age of 16 years 4. Women who cannot speak English or cannot read or write |
| Date of first enrolment | 01/04/2009 |
| Date of final enrolment | 01/04/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospital of North Staffordshire NHS Trust
Staffordshire
ST4 6QG
United Kingdom
ST4 6QG
United Kingdom
Sponsor information
University Hospital of North Staffordshire NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Darren Clement
Research and Development Manager
Research and Development Department
North Staffordshire Medical Institute
Hartshill Road
Hartshill, Stoke-on-Trent
Staffordshire
ST4 7NY
England
United Kingdom
| Website | http://www.uhns.nhs.uk/ |
|---|
Funders
Funder type
Charity
Smith and Nephew Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 24/07/2012 | Yes | No | |
| Results article | nested qualitative study results | 10/02/2017 | Yes | No | |
| Results article | results | 10/02/2017 | Yes | No |
Editorial Notes
20/10/2017: Publication reference added.
13/02/2017: Publication reference added.
