None listed
Conditions
Brief summary
The pilot study was to determine the safety and efficacy of a device which aimed to modify the repair of the extracellular matrix in skin. The hypothesis was that the structured magnetic field of the active device would enable a more efficient repair through enabling the alignment of molecules flowing into the wound thus decreasing the healing time and improving the strength of the repair. Although the intervention was intending to nanoengineer the repair, the outcomes were measured at a macroscopic level by taking photos of the wounds, removing sutures early to test wound strength and including the subject's experience of wearing the device. The control device was a weak active control, which permitted the discernment of a difference between each end to the wound corresponding to the active vs control devices yet enabled the clinical assessment of a weak dosage effect on the repair where the control end was found to have a significant clinical effect on wound strength.
Interventions
The intervention tested a novel wound dressing as a test device which contained one active half and a control half.
Materials- latex strip containing ferromagnetic materials emitting a structured magnetic field.
Procedure- the device was placed external to a conventional wound dressing and fixed in position for up to 3 days only. The device was applied to a skin excision wound after the conventional excision procedure. The wound was tested after removing the test device and photographing the wou
The intervention tested a novel wound dressing as a test device which contained one active half and a control half. Materials- latex strip containing ferromagnetic materials emitting a structured magnetic field. Procedure- the device was placed external to a conventional wound dressing and fixed in position for up to 3 days only. The device was applied to a skin excision wound after the conventional excision procedure. The wound was tested after removing the test device and photographing the wound and if the wound was clinically assessed as healed then sutures were removed from the end of the wound which appeared to have the more mature repair. Photos were also taken after any procedure and at standard review periods in the trial. The team that conducted the trial included a general practitioner with over 20 years clinical experience who performed all clinical assessments and procedures with 1-2 registered nurses and sometimes 1 general surgeon observing and assisting. The trial was conducted at the Southern Cross University Health Clinic on the Lismore campus as a series of clinical consultations. The recruitment to the trial was at a consultation where the patient was referred to have an excision by another doctor either from the clinic or another location. Informed written consent was obtained prior to the excision which was performed on day 0 of the trial and the device was applied after the wound had been covered, to remain in place until the first clinical review which was at day 3,2 or 1 depending on the stage of the trial. At the first review the device was removed and discarded, the dressings taken down and the wound assessed by the team. If the team could discern a more mature repair in one half of the wound then the wound was tested by removing sutures from that half of the wound. Wounds were photographed before and after all procedures in the trial at every review. Delayed outcomes were tested by reviewing the wounds again at day 7 and day 14.
Sponsors
Dr Rosemary Craig
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult with a skin lesion to be excised according to a practitioner external to the study; including diagnostic excision of suspicious lesions, therapeutic excisions of malignant lesions and excision of unwanted benign lesions.
Exclusion criteria
Pregnancy Unable to give consent in English
Outcome results
None listed