Trial Outcomes & Findings for Investigation of the Clinical Performance of Biatain Fiber Ag on Burns (NCT NCT05824026)

NCT ID: NCT05824026

Last Updated: 2025-09-11

Results Overview

The percentage of wounds achieving healing within 14 days (+/- 2 days). A wound was considered healed if re-epithelialization was visually assessed to be 95% or greater.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2025-09-11

Participant Flow

Participant milestones

Measure	Main Arm Non comparative - One armed - open labelled intervention. Each subject will contribute with one wound (named the study wound), which will be selected at inclusion prior to initiation of treatment. Each subject will wear the test dressing in a two weeks period with planned dressing changes once per week. The test dressing is a gelling fiber wound dressing with silver applied to the study wounds.
Overall Study STARTED	52
Overall Study Subjects Where Test Dressing Was Applied at Least Once	51
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Main Arm n=51 Participants Non comparative - One armed - open labelled intervention. Each subject will contribute with one wound (named the study wound), which will be selected at inclusion prior to initiation of treatment. Each subject will wear the test dressing in a two weeks period with planned dressing changes once per week. The test dressing is a gelling fiber wound dressing with silver applied to the study wounds.
Age, Categorical <=18 years	1 Participants n=51 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=51 Participants
Age, Categorical >=65 years	1 Participants n=51 Participants
Age, Continuous	38.9 years n=51 Participants
Sex: Female, Male Female	26 Participants n=51 Participants
Sex: Female, Male Male	25 Participants n=51 Participants
Region of Enrollment United Kingdom	51 participants n=51 Participants
Area of subjects' study wound	52.0 cm^2 n=51 Participants
Number of Participants with Signs of Infection in the Wound	2 Participants n=51 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Primary analysis was based on the full analysis set for subjects with non-missing data (completers). Post hoc sensitivity analysis and supplemental analysis were based on the full analysis set.

The percentage of wounds achieving healing within 14 days (+/- 2 days). A wound was considered healed if re-epithelialization was visually assessed to be 95% or greater.

Outcome measures

Measure	Main Arm n=51 Participants Non comparative - One armed - open labelled intervention. Each subject will contribute with one wound (named the study wound), which will be selected at inclusion prior to initiation of treatment. Each subject will wear the test dressing in a two weeks period with planned dressing changes once per week. The test dressing is a gelling fiber wound dressing with silver applied to the study wounds.
Percentage of Wounds Healed Within 14 Days Primary analysis (subjects with non-missing data, completers)	83.7 percentage of wounds healed Interval 69.3 to 93.2
Percentage of Wounds Healed Within 14 Days Post hoc sensitivity analysis (missing data imputed as not healed or using multiple imputation)	74.8 percentage of wounds healed Interval 60.7 to 85.1
Percentage of Wounds Healed Within 14 Days Supplemental analysis (missing data imputed as not healed)	70.6 percentage of wounds healed Interval 56.2 to 82.5

Adverse Events

Main Arm

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Main Arm n=52 participants at risk Non comparative - One armed - open labelled intervention. Each subject will contribute with one wound (named the study wound), which will be selected at inclusion prior to initiation of treatment. Each subject will wear the test dressing in a two weeks period with planned dressing changes once per week. The test dressing is a gelling fiber wound dressing with silver applied to the study wounds.
Immune system disorders Rash	1.9% 1/52 • Number of events 1 • 2 weeks (+/- 2 days)
Cardiac disorders Hypotension	1.9% 1/52 • Number of events 1 • 2 weeks (+/- 2 days)
Vascular disorders Swollen feet and ankles	1.9% 1/52 • Number of events 1 • 2 weeks (+/- 2 days)

Other adverse events

Measure	Main Arm n=52 participants at risk Non comparative - One armed - open labelled intervention. Each subject will contribute with one wound (named the study wound), which will be selected at inclusion prior to initiation of treatment. Each subject will wear the test dressing in a two weeks period with planned dressing changes once per week. The test dressing is a gelling fiber wound dressing with silver applied to the study wounds.
Skin and subcutaneous tissue disorders Severe pain from dressed burn wound	1.9% 1/52 • Number of events 1 • 2 weeks (+/- 2 days)
Skin and subcutaneous tissue disorders Dressing difficult to remove/wound bleeding after dressing removal	9.6% 5/52 • Number of events 5 • 2 weeks (+/- 2 days)
Skin and subcutaneous tissue disorders Pain at the site where dressing had been applied	1.9% 1/52 • Number of events 1 • 2 weeks (+/- 2 days)
Infections and infestations Wound infection (not study wound)	3.8% 2/52 • Number of events 2 • 2 weeks (+/- 2 days)
Infections and infestations Chest infection	1.9% 1/52 • Number of events 1 • 2 weeks (+/- 2 days)
Gastrointestinal disorders Diarrhoea	1.9% 1/52 • Number of events 1 • 2 weeks (+/- 2 days)

Additional Information

Clinical Strategy Project Manager: Johanne Louise Gotfredsen

Coloplast A/S

Phone: 004549113350

Email: dkjoat@coloplast.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place