The effects on post-operative pain of a warming dressing applied after hernia surgery

ISRCTN	ISRCTN59897148
DOI	https://doi.org/10.1186/ISRCTN59897148
Protocol serial number	N0159119156
Sponsor	Department of Health (UK)
Funder	North Tees and Hartlepool NHS Foundation Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Andrew Melling
Scientific

Clinical Research Nurse
Professorial Unit of Surgery
North Tees General Hospital
Stockton-on-Tees
TS19 8PE
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	1. Post-operative pain scores 2. Quality of life 3. Wound healing
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Clinical Research Nurse

Stockton-on-Tees
TS19 8PE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2006		Yes	No