Insulin Resistance, Diabetes, Wound Complication
Conditions
Brief summary
This study aimed to investigate the potential effect of applying topical insulin therapy on the management and healing of postoperative wounds in patients known with type 2 diabetes mellitus (T2DM) and in a parallel group without diabetes. Investigators also studied the effect of topical insulin therapy on the expression of e-cadherin and Ki67, as markers for cellular proliferation and wound repair. The levels of IL-6 and the H2O2-induced DNA damage product, 8-hydroxy-2'-deoxyguanosine (8-OHdG), were assessed as markers for inflammation and oxidative stress. Finally, histomorphological assessment of skin biopsies was also carried out.
Detailed description
The study participants will be recruited from general surgery department ,all patients with elective surgical procedure who will be admitted at the department for at least one week as it is the minimal duration of postoperative wound healing and the study will be conducted according to the regulations of ethical committee of clinical studies in the Faculty of Medicine, Cairo University
Interventions
DRUGInsulin
Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment
DRUGPovidone-Iodine
Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
2 parallel groups, one treated with conventional povidone iodine 10% and the other is treated with topical insulin
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Both males and females * 40-60 years old * diagnosed with type 2 DM (for the diabetic trial) * For the diabetic trial: glycosylated hemoglobin (HBA1c) ≤7.5 % * haemoglobin (Hb) ≥ 12 g/dl * Patients who had a full thickness post-operative wound of ≥10 cm
Exclusion criteria
* Those with known history of immunodeficiency, keloid formation, or hyperkeratotic skin lesion. * Patients who had hypersensitivity to insulin, * Patients with severe infection, * Patients with any severe organ dysfunction * Patients who were admitted to ICU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calculation of Unit Healing Time index | Before and after 7 days of therapy | The total healing days and the surface area of the wound will be combined to report unit healing time in units |
Countries
Egypt
Outcome results
None listed