The effects on post-operative pain of a warming dressing applied after hernia surgery
| ISRCTN | ISRCTN59897148 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59897148 |
| Secondary identifying numbers | N0159119156 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 30/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Andrew Melling
Scientific
Scientific
Clinical Research Nurse
Professorial Unit of Surgery
North Tees General Hospital
Stockton-on-Tees
TS19 8PE
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The application of warmth to an area has traditionally been linked with reduction in pain. In this study this theory will be tested. Localised warming to the wound area will increase blood flow and therefore provide more oxygen to the wound. The increase in blood flow and post-operative tissue oxygenation in the wound area may help to reduce post-operative pain. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Post-operative pain |
| Intervention | Group A: Standard treatment (no warming) Group B: Two hours of postoperative warming to the wound immediately after surgery and then the patients warm their wounds twice a day for the first three postoperative days at home. An exothermic warming pad that adheres to the wound dressing provides the warmth Pain scores are recorded for the first four hours after surgery and then over the next two weeks by the patient. Wounds are observed independently and healing is assessed at weeks two and six. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Post-operative pain scores 2. Quality of life 3. Wound healing |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2002 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 180 |
| Key inclusion criteria | Patients having hernia surgery (n = 180) |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Clinical Research Nurse
Stockton-on-Tees
TS19 8PE
United Kingdom
TS19 8PE
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
North Tees and Hartlepool NHS Foundation Trust (UK)
No information available
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? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2006 | Yes | No |
