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NCT06400082 Clinical Trial

Topical Insulin for Postoperative Wound Healing

Wound Complication Clinical Trial

Official title:
Investigating the Impact of Topical Insulin on Postoperative Wound Healing in Diabetic and Non-Diabetic Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06400082
Other study ID # 16-4-2023
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 16, 2023
Est. completion date July 10, 2024

Study information
Verified date May 2024
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 74
Est. completion date July 10, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Insulin
Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment
• Povidone-Iodine
Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment

Locations
Country Name City State
Egypt Omnia Azmy Nabeh Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Calculation of Unit Healing Time index The total healing days and the surface area of the wound will be combined to report unit healing time in units Before and after 7 days of therapy
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