None listed
Conditions
Brief summary
This research aims to work out how doctors should best manage wounds after minor skin surgery. Following excision surgery for minor skin lesions, dressings are used for a period of time to keep the wound clean and comfortable. This study is a randomised controlled trial of two types of dressings and dressing protocols following minor skin surgery in general practice. The first part of the study compares participant pain levels with a dressing containing a pain relief medication (ibuprofen) compared to an identical non-medicated dressing. The second part of this study will compare whether keeping the wound covered until stitches are removed, or removing the dressing at 48 hours is better in terms of patient pain and comfort, and infection rates. On the day of their skin surgery, participants will be randomised into one of four treatment groups: (plain dressing or ibuprofen dressing, with the dressing to be removed at 48 hours and the wound kept uncovered, or a further plain dressing applied until stitches are removed). Participants will be asked to fill out a pain score sheet once a day for 5 days after their surgery. Participants will be contacted by the researchers on day 3 after surgery and asked questions about their wound comfort. When they return for removal of stitches, participants will be again asked questions about wound comfort, and the wound will be inspected for signs of infection. Outcomes to be measured include participant pain scores, additional use of oral pain relief medication, presence of wound infection, and patient comfort levels.
Interventions
Arm 1: dressing impregnated with ibuprofen applied to wound for 48 hours, after which wound remains uncovered until suture removal
Arm 2: dressing impregnated with ibuprofen applied to wound for 48 hours, after which wound is covered with another plain dressing until suture removal
Arm 3: plain non-medicated dressing applied to the wound for 48 hours, after which wound remains uncovered until suture removal
Arm 4: plain non-medicated dressing applied to the wound for 48 hours, after which wound
Arm 1: dressing impregnated with ibuprofen applied to wound for 48 hours, after which wound remains uncovered until suture removal Arm 2: dressing impregnated with ibuprofen applied to wound for 48 hours, after which wound is covered with another plain dressing until suture removal Arm 3: plain non-medicated dressing applied to the wound for 48 hours, after which wound remains uncovered until suture removal Arm 4: plain non-medicated dressing applied to the wound for 48 hours, after which wound is covered with another plain dressing until suture removal Dressing Details The ibuprofen-impregnated dressing contains 0.5mg/cm2 of ibuprofen homogenously dispersed through a foam matrix. The ibuprofen-impregnated dressing and the plain non-medicated dressing consist of a polyurethane foam. The dressing will be applied by a general practitioner or nurse. The dressing application will occur in a general practice clinic. The approximate duration of time between removal of the dressing and suture removal is 7-14 days. Adherence to the intervention will be monitored by the researchers who will phone participants on day 3 post-surgery
Sponsors
University of New England
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients presenting to their general practitioner for minor surgical excision of a skin lesion 18 years of age or over
Exclusion criteria
Excision of lesions on the face Patients already on oral antibiotics Patients on immunosuppressive drugs Traumatic wounds Patients who are unable to communicate effectively either due to language barrier or cognitive impairment Patients with a known contraindication, allergy or adverse reaction to ibuprofen or any component of the dressing. Patients with a wound that has skin integrity concerns eg difficult closure with poorly perfused skin Pregnancy or breastfeeding
Outcome results
None listed