NCT07149844

Brief Summary

Tea tree oil (TTO) has been recognized for its effectiveness in treating infected burns, insect bites, and promoting wound healing. This clinical study aimed to compare the impact of Tea tree oil dressings versus conventional ones in the healing process of second degree burns wounds.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jul 2021

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
Last Updated

September 12, 2025

Status Verified

August 1, 2025

Enrollment Period

2.1 years

First QC Date

August 18, 2025

Last Update Submit

September 8, 2025

Conditions

Keywords

BurnTea Tree Oil

Outcome Measures

Primary Outcomes (2)

  • morphological wound changes

    assessment of: wound bed, wound margin: color, size, depth, presence of exudates: its amount, color, odor, and type, or scare, edema and granulation tissue formation; in addition to assessment of the wound's surrounding skin condition for: erythema, hotness, tenderness, swelling, separation of deep tissues, fever and peri-wound skin laceration. Each item was rated to score on 2 points Likert scale: 0 = not present and 1= Present. A total score of every patient in both groups was summed up and converted into percent score. to desribe wound healing process as ; complete healing: ; Partial healing: and No healing: where higher percent represent better healing

    3 weeks

  • Local infection scoring system

    Local infection scoring system was recorded as: 0= Absence of infection. 1= Presence of local signs of wound infection (redness, hotness, tenderness, purulent discharge and swelling)2 = Presence of systemic wound infection signs (fever, elevated WBCs, ESR and elevated CRP)

    3 weeks

Study Arms (1)

conventional dressing

OTHER

Conventional dressing: Is the routine study hospital's burn dressing technique, utilizing sterile topical gauze dressing that is impregnated with or laid over a topical antibacterial, silver sulphadiazin dressing secured with adhesive tape.

Drug: tea tree oil ointment

Interventions

Petrolatum (petroleum jelly) was sterilized in the oven at 160°C for 90 min, then The ointment was prepared as 10% .

Also known as: فtea tree ointment
conventional dressing

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient willing to participate and communicate
  • Newly admitted with recent 2nd-degree burns (superficial or deep) involving ≤10% of TBSA
  • Length of hospital stay of 10 days

You may not qualify if:

  • Any associated illnesses that may affect wound healing, such as:
  • Diabetes mellitus (DM)
  • Immune disorders
  • Pre-existing skin conditions (e.g., eczema)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ras Eltin Hospital

Alexandria, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • hoda fathy, prof

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2025

First Posted

September 2, 2025

Study Start

July 2, 2021

Primary Completion

July 22, 2023

Study Completion

September 22, 2023

Last Updated

September 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

data can be shared on researchgate or other official database

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
upon acceptance of the manuscript
Access Criteria
upon request

Locations