Topical Insulin for Postoperative Wound Healing

NCT ID: NCT06400082

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-16
• Study Completion Date: 2024-12-10

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

Conditions

Wound Complication; Insulin Resistance, Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Povidone iodine 10%

Group Type: ACTIVE_COMPARATOR

Povidone-Iodine

Intervention Type: DRUG

Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment

Topical insulin

Group Type: EXPERIMENTAL

Insulin

Intervention Type: DRUG

Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment

Interventions

Insulin

Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment

Intervention Type: DRUG

Povidone-Iodine

Insulin is applied as a topical dressing for postoperative wounds and compared to the conventional povidone iodine treatment

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Omnia Azmy Nabeh

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omnia Azmy Nabeh, MD

Role: STUDY_CHAIR

Cairo University

Locations

Omnia Azmy Nabeh

Cairo, , Egypt

Countries

Egypt

Other Identifiers

16-4-2023

Identifier Type: -

Identifier Source: org_study_id