Insulin as anti-scarring agent - breast surgery group

• Research type

  Research Study

• Full title

  An investigation of the efficacy of a single dose of insulin in the prevention of excessive cutaneous scarring in breast surgery patients

• IRAS ID

  19748

• Contact name

  Charles Nduka

• Sponsor organisation

  Pharmecosse

• Eudract number

  2010-022290-34

• ISRCTN Number

  ISRCTN51295799

• Research summary

  Can a single application of low dose insulin to the edges of a surgical wound significantly reduce the amount of scar tissue formed in non cancer-related bilateral breast surgery patients?The purpose of this trial is to determine the efficacy of a single application of insulin in reducing scar formation. Scarring is an immense clinical problem estimated to affect 100 million patients per annum. Scars affect both appearance and function. Scar tissue??s inflexibility and contraction reduces mobility and function of affected body parts, joints and orifices such as the eye and mouth. Scarring results in disfigurement, disability, psychological problems alongside requiring multiple further corrective surgical procedures to reconstruct features and restore function. Currently there is no truly effective anti-scarring treatment available to patients. Development of such a treatment would significantly improve quality of life for thousands of patients per annum, and reduce costs to the NHS.Laboratory research together with a small clinical trial (15 patients) has provided evidence for a novel anti-scarring activity of insulin, where application of a single low dose early after wounding significantly reduces the scar-tissue-producing cells present and consequently scar tissue. The proposed large-scale multi-centre clinical trial. involves 75 patients undergoing non cancer-related breast surgery to be recruited across two hospital sites. These patients have two identical wounds (one per breast), allowing matched intrapatient placebo-control.Each patient after giving informed consent would undergo their elective surgical procedure as per routine apart from each breast wound would be randomly allocated to receive either insulin or the placebo as subcutaneous injection along a 3cm end of the wound. Patients would be followed up as per routine (2-3wks and 3months) plus two additional follow-ups appointments at 6 and 12 months. At each of these their wound/scar would be assessed, photographed and a silicone mould taken by the nursing practitioner.

• REC name

  London - South East Research Ethics Committee

• REC reference

  10/H1102/67

• Date of REC Opinion

  25 Oct 2010

• REC opinion

  Favourable Opinion