Skin repair after excisions using a novel dressing; a clinical pilot study

Not Applicable

Completed

Conditions: Skin - Other skin conditions
Skin repair

Registration Number: ACTRN12622000587707

Lead Sponsor: Dr Rosemary Craig

Brief Summary: The trial tested the safety and efficacy of a device which aimed to modify skin repair after excisions since these are high tension skin wounds. The device included an active and control half so that each wound could demonstrate a difference. 30 adults who had a skin lesion removed wore the device for up to 3 days and then the wounds were tested by physical examination, photographing the wounds, and removing sutures early. Results Sutures were removed early (within three days) in 23 out of 30 wounds. Of these, sutures were removed from the active end in 20 out of 23 cases. One wound opened a number of hours after suture removal due to physical trauma possibly predisposed by a low vitamin-C level. Conclusion The application of the novel wound dressing was associated with reduced healing times and enabled the removal of sutures 1 day after the wound was closed in some patients.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Whether there was a clinically evident difference between each half of the wound as assessed by physical examination, gaining consensus between 2 or more blinded clinical assessors, confirmed by digital photography of the wounds.[At day 3 after the excision, then day 2 and day 1 as more participants passed through the trial.];Whether the wound remained closed after sutures were removed from the half of the wound at first review as assessed by physical examination, gaining consensus between 2 or more blinded clinical assessors, and confirmed by digital photography.[At day 3, then day 2 and day 1 as more participants passed through the trial.]

Secondary Outcome Measures

Name	Time	Method
Dehiscence, whether the wound remained entirely closed after sutures were removed as assessed by physical examination, gaining consensus between 2 or more blinded clinical assessors, and confirmed by digital photography.[Tested at day 7 and day 14 after the excision.];Subjects provided feedback on the experience of wearing the device and participating in the trial using a questionnaire specifically designed for the study using a 7 point scale for responses; Very Bad, Mostly Bad, Sometimes Bad, Neither, Sometimes Good, Mostly Good, Very Good.[Recorded after the device was removed and at each subsequent review on day 7 and day 14.]