Condition category
Surgery
Date applied
02/03/2011
Date assigned
11/11/2011
Last edited
06/08/2013
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 Ciaran Healy

ORCID ID

Contact details

Consultant Plastic Surgeon
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GSTT R&D registration number RJ1080009

Study information

Scientific title

A prospective, controlled, randomised study to evaluate pain in split skin graft donor sites dressed with fibrin sealant (Tisseel®, Baxter) and adhesive dressings versus adhesive dressings directly applied to the donor site

Acronym

Study hypothesis

Fibrin sealant significantly reduces pain in split skin graft donor sites

Ethics approval

Ethics approval obtained from Guys and St Thomas' Ethics Committee on 11th January 2008, ref: 06Q0701/92

Study design

Randomised active control parallel assignment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pain in split skin graft donor sites

Intervention

A prospective, randomised controlled trial was performed. The self-adhesive fabric dressing Mefix® (Mölnlycke Health Care Ltd) was used as a control and compared to fibrin glue spray (Tisseel®, Baxter Healthcare Ltd) plus Mefix®.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Daily pain and disability scores from day 1 to 14 post-operatively using a Visual Analogue Scale

Secondary outcome measures

1. Length of hospital stay
2. Duration of requirement for dressings

Overall trial start date

11/01/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 years old and over
2. Conscious during post operative period
3. Small to moderate area of split skin graft (SSG) procedure necessary
4. Lateral thigh SSG donor site preferable

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Hypersensitivity to beef or beef products ((Tisseel® is produced from bovine aprotonin)
2. Those requiring thicker grafts, greater than 8/1000 inch
3. Thigh donor sites unavailable. Back and buttocks can be used as donor sites in certain cases, they may have a different pain profile
4. Known immunodeficiency will have an effect on healing
5. Mental incapacity to consent or undertake questionnaire
6. Concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days to avoid confounding factors
7. Alternative source of severe distracting pain which may down score donor site pain

Recruitment start date

11/01/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Plastic Surgeon
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Guy’s and St Thomas’ NHS Foundation Trust (UK)

Sponsor details

Consultant Plastic Surgeon
c/o Mr Ciaran Healy (Principal Investigator)
Department of Plastic Surgery
St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Guy's and St Thomas' Hospital (UK) - Plastic Surgery Academic Fund

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

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23806933

Publication citations

  1. Results

    Healy C, Greig AV, Murphy AD, Powell C, Pinder RJ, Saour S, Abela C, Knight W, Geh JL, Prospective randomized controlled trial: fibrin sealant reduces split skin graft donor-site pain., Plast. Reconstr. Surg., 2013, 132, 1, 139e-46e, doi: 10.1097/PRS.0b013e318299c6f4.

Additional files

Editorial Notes