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

Effect of Topical Active Oxygen Therapy on Surgical Site Wound Healing and Microbial Colonization : Randomized Controlled Clinical Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: Patients Scheduled for Any Oral Surgical Flap Procedure That Require Suturing Will Be Included in This Study
• Intervention / Treatment: Drug: topical oxygen gel

Detailed Description

All the patients who will agree to participate in the study and who will sign the informed consent forms. Computer-generated randomization will be used to randomly divide the surgical sites into two groups. Control group: will receive no treatment. Study group: will receive active oxygen gel around suture. Patients scheduled for any oral surgical flap procedure that require suturing will be included in this study. After flap approximation, the surgical site will be sutured using 5-0 braided sutures. 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, three times a day after brushing their teeth. Also, patients will be given instructions regarding their post-surgical care.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Al Sherouk, Cairo, Egypt, 11837
      • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; patient who will undergo intraoral surgical procedures , will have his wound sutured without any addtives
Active Comparator: test; patient who will undergo intraoral surgical procedures , will have his wound sutured with the addition of blue m gel twice daily	Drug: topical oxygen gel; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbiological assessment	The collected samples of suture thread will be immersed in phosphate-buffered saline solution (PBS) immediately after their removal and This sample will be subsequently sent to the microbiology laboratory of the Faculty of Pharmacy of the British university in Egypt. The samples will be shaken vigorously for two minutes to separate the bacteria from the suture thread, and to obtain a homogeneous suspension. serial dilutions in saline will be subsequently prepared. 50 microliters of each dilution will be plated in Petri dishes containing different culture media.The blood agar, mannitol agar, MacConkey agar, and Sabouraud agar plates will be aerobically incubated at 37 °C for 24-48 hours. After incubation, the colony forming units (CFUs) will be counted and the total number of CFUs per milliliter of initial solution will be calculated	2 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University
• Collaborators: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: November 23, 2024
• First Submitted That Met QC Criteria: November 23, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 23, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: wound healing; microbiology; sutures; flap; active oxygen
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 24-042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No