Effect of Topical Active Oxygen Therapy on Surgical Site Wound Healing and Microbial Colonization

NCT06705920 | Active Not Recruiting Early Phase 1 DMC

• 1 other identifier: 24-042
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the antibacterial efficiency of oxygenated gel therapy on wound healing and microbiological colonization around surgical sutures

Conditions

Patients Scheduled for Any Oral Surgical Flap Procedure That Require Suturing Will be Included in This Study

Keywords

active oxygen; sutures; flap; microbiology; wound healing

Outcome Measures

Primary Outcomes (1)

• Post operative wound healing.

  Wound healing will be recorded in the 1st and 2 weeks postoperatively through Landry Wound Healing Index (LWHI) which evaluates the surgical site based on tissue color, response to touch, the marginality of the incision line, and extent of the area. The rating is from 1 = very poor to 5 = excellent.

  2 weeks

Secondary Outcomes (1)

• Microbiological assessment

  2 weeks

Study Arms (2)

control

NO INTERVENTION

patient who will undergo intraoral surgical procedures , will have his wound sutured without any addtives

test

ACTIVE COMPARATOR

patient who will undergo intraoral surgical procedures , will have his wound sutured with the addition of blue m gel twice daily

Interventions

topical oxygen gel DRUG

In the study group the gel will be applied over the suture and the patients will be instructed to apply the gel to the wound area and to the suture thread using a cotton swab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients in a healthy systemic condition who required comprehensive dental treatment
• Both genders with age group \> 18 years old
• Patients should approve to deliver a signature to a written consent after study nature explanation.

You may not qualify if:

• Patients with severe smoking habits \>10 cig \\ day
• Pregnant females, decisional impaired individuals and handicapped patients
• Patients having poor oral hygiene or not wanting to carry out oral hygiene measures
• Patients on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin)

Sponsors & Collaborators

• Ain Shams University: lead
• British University In Egypt: collaborator

Study Sites (1)

Faculty of Dentistry

Cairo, Cairo Governorate, 11837, Egypt

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: November 23, 2024
• First Posted: November 26, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)