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A Comparison of Wound Healing Efficacy between a Herbal-coated Lipidocolloid Dressing and a Paraffin-based Dressing in Pediatric Burn Patients - A Randomized Controlled Study

A comparison of wound healing efficacy between Herbal-coated lipidocolloid dressing and Bactrigas paraffin-based dressing in pediatric burn patients- a randomized controlled study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210822001
Enrollment
28
Registered
2021-08-22
Start date
2021-11-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatric population age of 0 - 15 Partial thickness burn burn paediatric Paraffin based dressing Herbal coated dressing

Interventions

Patient will receive Herbal coated lipidocolloid dressing apply to burn wound area and change alternate day in the first week and the alternate day after two days in the following weeks. The photograp
Experimental Device,Active Comparator Device
Herbal coated lipidocolloid dressing ,Paraffin based dressing

Sponsors

Nakhonpathom Hospital
Lead Sponsor
Bangkok Botanica company
Collaborator

Eligibility

Sex/Gender
All
Age
1 Days to 15 Years

Inclusion criteria

Inclusion criteria: Pediatric patients age less than or equal to 15 years Partial thickness skin burn wound in any area of body less than 20 percent Thermal injury namely scalds or flame burn wound

Exclusion criteria

Exclusion criteria: Burn wound caused by chemical burn and electrical burn Full thickness of burn wound requiring grafting Known underlying diseases that may affect wound healing such as autoimmune disease, connective tissue disease, diabetes mellitus etc. 4. Current medication that may affect wound healing such as steroid 5. Unable to follow up 6. Known allergic to study wound dressing material eg. allergic to chlorhexidine (Bactrigras paraffin-based dressing contains chlorhexidine) 7. Partial thickness skin burn wound at face, hand, foot, genitalia and perineum

Design outcomes

Primary

MeasureTime frame
Duration of complete wound healing At the first day to complete wound epithelialization Duration of complete wound healing 100% of burn area

Secondary

MeasureTime frame
To report the percentage of area of wound healing in day 1, 3, 5, 8, 11, 14, 17, 20, 23 or until the completion of wound achieved at the day 1, 3, 5, 8, 11, 14, 17, 20, 23 and until completed wound healing Percentage of area of wound healing each day compared to the first day of injury,To compare pain score for each wound dressing material At day 1, 3, 5, 8, 11, 14, 17, 20, 23 Under 6 years old using Face Leg Activity Crying Consolidation (FLACC) and equal or more than 6 years old using Wong-Baker FACES Pain Rating Scale,To report guardian satisfaction towards the wound dressing material At the day wound healing complete 0 - 100,To report rate of patients requiring antibiotics or wound debridement From start to the day of wound healing complete Number of patients require antibiotics,To report difficult of the process of changing wound dressing At day 1, 3, 5, 8, 11, 14, 17, 20, 23 3 scales of difficulty to remove the dressing,To report the bleeding of the process of changing wound dressing At the day 1, 3, 5, 8, 11, 14, 17, 20, 23 4 scale of bleeding after removal of the dressing

Countries

Thailand

Contacts

Public ContactNutthavit Hantanyapong

Nakhonpathom Hospital

koh25008@outlook.com0819250538

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026