Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mr JD Nancarrow


Contact details

Burns & Plastics
Selly Oak Hospital
B29 6JD
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

1. We want to revisit the anatomy of a split skin graft. Our understanding of the healing of donor sites is based on work done in the 1920s at a time when grafts were taken by a hand knife. We are not sure the modern mechanical dermatomes take the same amount of skin or damage the same amount of the dermis (the deeper layer of skin that is left behind when a graft is taken). Therefore we wish to look at the skin that is left behind histologically following the harvest of split skin using a mechanical dermatome set at various thicknesses.
2. We wish to look at the effect of EMLA (eutectic mixture of local anaesthetics) on the skin thickness that is left behind for the same dermatome settings.
3. We also want to know if local anaesthetics interfere with cell growth which is of great importance when harvesting skin for culture in burns patients.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Not Specified

Patient information sheet


Surgery: Skin graft


EMLA cream is frequently used in the harvesting of split skin grafts. It provides sufficient anaesthesia for grafts to be taken without any supplemental anaesthetic agent. Reports suggest the application of EMLA cream may result in variations in skin thickness. This change in skin thickness may have significant consequences on the subsequent graft taken. The aim of this study is to assess histologically the effect of EMLA cream on the thickness of split skin grafts taken and the effects of local anaesthetics on skin culture.

A randomised controlled trial will be performed to assess the thickness of split skin grafts taken using EMLA cream and the effect of local anaesthetic on cell culture. The investigators, who will provide verbal and written information regarding the trial, will approach patients. If the patient agrees to participate written consent will be obtained.

EMLA cream, occlusive dressings, lidocaine

Preoperative Preparation
The operating surgeon will mark the abdomen for the abdominoplasty procedure. The surgeon, will then offer the patient envelopes in order to randomise EMLA to either the right or left side of the abdominoplasty. The cream will then be applied and an occlusive dressing applied at least 2 hours prior to surgery.

Intraoperative Procedure
In theatre, the occlusive dressing and cream will removed from the abdomen. Lignocaine will be injected under the skin on the other side of the abdomen. The dermatome will be used to harvest the split skin grafts. The dermatome thickness will be adjusted so three grafts of varying thickness will be taken on across the abdomen (4, 8, 12 /1000th of an inch). Six core biopsies (6mm in diameter) will be taken from the edge of the donor sites. These specimens will then placed in formalin to fix
the tissue for analysis be forwarded to the histopathology department for histological analysis. A further three core biopsies from each area will be taken for cell culture. These will be wrapped in saline soaked gauze, and sent in plain sterile containers carefully labelled to the skin laboratory. The abdominoplasty procedure will continue as normal following excision of the unwanted abdominal skin. Postoperatively, the patient will require no further follow-up from the study investigators and no long term consequences from the study are anticipated as the skin used would have been discarded anyway.

Histological Assessment
Core biopsies will be taken from the edges of the donor sites to include adjacent normal skin. This method will allow analysis of the thickness of skin removed. Once this analysis has been performed and results recorded, the specimens will be destroyed. Photographs of histological findings with all patient identifiers removed may be used in the publication of results.

Cell culture Assessment
Using standardised cell culture techniques, the skin biopsies from each area of local anaesthetic and control will be cultured. Cell counts will be performed for keratinocytes and fibroblasts at the appropriate intervals.

Statistical Analysis
The skin thicknesses for the EMLA and control specimens will then be analysed for statistical significance as discussed with the Trust statistician.

Intervention type



Not Specified

Drug names

EMLA cream, lidocaine

Primary outcome measure

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Patients undergoing abdominoplasty surgery will be recruited for the trial. These patients will be recruited from clinics where they have attended for discussion of the procedure. The area of skin to be discarded as part of the routine abdominoplasty procedure will be used for the trial.
If the patient agrees to participate written consent will be obtained. Inclusion criteria include:
1. Low anaesthetic risk patients (ASA I)
2. Previous sensitivity to opsite, EMLA, lidocaine or prilocaine, as these are the materials to be tested.
Long term steroid use, as this affects the structure of the skin (by thinning it), and can affect wound healing, which may adversely affect the cell culture

Participant type


Age group



Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Long term steroid use, previous adverse reaction to EMLA, prilocaine or lidocaine.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Burns & Plastics
B29 6JD
United Kingdom

Sponsor information


Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
United Kingdom
+44 (0)20 7307 2622

Sponsor type




Funder type


Funder name

University Hospital Birmingham NHS Trust (UK), NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2008 results in

Publication citations

  1. Results

    Mary O'Brien C, Breuning E, Webb J, Balderson D, Nancarrow J, A prospective randomised controlled trial to investigate the effect of local anaesthetic in vivo on cell culture., J Plast Reconstr Aesthet Surg, 2008, 61, 10, 1232-1234, doi: 10.1016/j.bjps.2007.09.006.

Additional files

Editorial Notes