Topical Insulin for Postoperative Wound Healing

Not Applicable

Active, not recruiting

• Conditions: Wound Complication; Insulin Resistance, Diabetes
• Interventions: Drug: Insulin; Drug: Povidone-Iodine

• Registration Number: NCT06400082
• Lead Sponsor: Cairo University

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

Study Timeline

• Study Start: 2023-04-16
• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-05-02
• Study First Posted: 2024-05-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2024-10-01
• Study Completion: 2024-12-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical insulin	Insulin	-
Povidone iodine 10%	Povidone-Iodine	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Omnia Azmy Nabeh; 🇪🇬 Cairo, Egypt