Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0159119156
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
1. Post-operative pain scores
2. Quality of life
3. Wound healing
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2002
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Patients having hernia surgery (n = 180)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
180
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2002
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Research Nurse
Stockton-on-Tees
TS19 8PE
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Tees and Hartlepool NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2006 results in: http://www.ncbi.nlm.nih.gov/pubmed/16550663
Publication citations
-
Results
Melling AC, Leaper DJ, The impact of warming on pain and wound healing after hernia surgery: a preliminary study., J Wound Care, 2006, 15, 3, 104-108.