The effect of pre-operative warming on wound infection rates after clean surgery
| ISRCTN | ISRCTN54949546 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54949546 |
| Secondary identifying numbers | AP0728 |
- Submission date
- 01/03/2001
- Registration date
- 01/03/2001
- Last edited
- 07/01/2010
- 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
Professorial Unit of Surgery
North Tees and Hartlepool NHS Trust
North Tees General Hospital
Stockton-on-Tees
TS19 8PE
United Kingdom
| Phone | +44 (0)1642 624087 |
|---|---|
| AndyMelling@compuserve.com |
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 | Laser doppler flowmetry of skin circulation to measure the effects of using two warming therapies: a randomised clinical trial of surgical patients |
| Study objectives | To assess whether warming patients before short duration, clean surgery will reduce infection rates. |
| Ethics approval(s) | No ethics approval information required at time of registration |
| Health condition(s) or problem(s) studied | Infection during surgery |
| Intervention | Patients were randomised to one of three groups: 1. Standard treatment - no warming 2. Local warming - a minimum of 30 minutes localised warming to the potential incision site using a waming dressing 3. Systemic warming - a minimum of 30 minutes warming to the whole body using a warm blown air blanket Both warming devices were applied prior to surgery. A cohort of patients had laser doppler and TcPO2 recordings taken prior to warming, after warming and after surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Wound infection; masked outcome assessments made at 2 and 6 weeks |
| Secondary outcome measures | Added as of 07/01/2010: 1. Skin preparation; masked outcome assessments made at 2 and 6 weeks 2. Length of operation; masked outcome assessments made at 2 and 6 weeks 3. Administration of prophylactic antibiotics; masked outcome assessments made at 2 and 6 weeks 4. Experience of the operating surgeon; masked outcome assessments made at 2 and 6 weeks 5. Core temperature, measured before any treatment, after any warming, and after surgery |
| Overall study start date | 01/01/2001 |
| Completion date | 31/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 421 |
| Key inclusion criteria | 1. Patients having clean breast, varicose vein or hernia surgery Added as of 07/01/2010: 2. Surgery results in a scar longer than 3 cm in length |
| Key exclusion criteria | Added as of 07/01/2010: 1. Under the age of 18 years 2. Pregnant 3. Taking long-term oral steroids 4. Received radiotherapy (to the incision site) or chemotherapy in the last 4 weeks 5. Had an infection at the time of surgery |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 31/12/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Professorial Unit of Surgery
Stockton-on-Tees
TS19 8PE
United Kingdom
TS19 8PE
United Kingdom
Sponsor information
Action Medical Research (UK)
Charity
Charity
Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom
| Website | http://www.action.org.uk/ |
|---|---|
"ROR" |
https://ror.org/01wcqa315 |
Funders
Funder type
Charity
Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- actionmedres, action medical research for children, AMR
- 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? |
|---|---|---|---|---|---|
| Results article | results | 15/09/2001 | Yes | No |
