Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
30/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Andrew Melling

ORCID ID

Contact details

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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes