Trial Outcomes & Findings for AQUACEL® Ag+ Extra™ and Cutimed™ Sorbact® Dressing in the Management of Venous Leg Ulcers Over a 12-week Period (NCT NCT05892341)

NCT ID: NCT05892341

Last Updated: 2025-12-02

Results Overview

Complete wound closure as defined by 100% epithelialisation of the wound surface (Gould 2019)

Recruitment status

COMPLETED

Study phase

Target enrollment

203 participants

Primary outcome timeframe

Up to 12 weeks

Results posted on

2025-12-02

Participant Flow

Unit of analysis: Wounds

Participant milestones

Participant milestones
Measure	AQUACEL® Ag+ Extra™ AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing AQUACEL® Ag+ Extra™: Wound treatment with AQUACEL® Ag+ Extra™ dressing	Cutimed® Sorbact® Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing Cutimed® Sorbact®: Wound treatment with Cutimed® Sorbact® dressing
Overall Study STARTED	101 109	102 110
Overall Study COMPLETED	88 96	79 85
Overall Study NOT COMPLETED	13 13	23 25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AQUACEL® Ag+ Extra™ n=101 Participants AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing AQUACEL® Ag+ Extra™: Wound treatment with AQUACEL® Ag+ Extra™ dressing	Cutimed® Sorbact® n=102 Participants Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing Cutimed® Sorbact®: Wound treatment with Cutimed® Sorbact® dressing	Total n=203 Participants Total of all reporting groups
Age, Customized < 65	38 Participants n=101 Participants	42 Participants n=102 Participants	80 Participants n=203 Participants
Age, Customized 65-79	44 Participants n=101 Participants	41 Participants n=102 Participants	85 Participants n=203 Participants
Age, Customized 80+	19 Participants n=101 Participants	19 Participants n=102 Participants	38 Participants n=203 Participants
Sex: Female, Male Female	71 Participants n=101 Participants	56 Participants n=102 Participants	127 Participants n=203 Participants
Sex: Female, Male Male	30 Participants n=101 Participants	46 Participants n=102 Participants	76 Participants n=203 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Colombia	59 Participants n=101 Participants	59 Participants n=102 Participants	118 Participants n=203 Participants
Region of Enrollment United Kingdom	20 Participants n=101 Participants	22 Participants n=102 Participants	42 Participants n=203 Participants
Region of Enrollment Germany	22 Participants n=101 Participants	21 Participants n=102 Participants	43 Participants n=203 Participants
BMI	31.84 kg/m2 STANDARD_DEVIATION 8.26 • n=101 Participants	30.06 kg/m2 STANDARD_DEVIATION 6.12 • n=102 Participants	30.95 kg/m2 STANDARD_DEVIATION 7.19 • n=203 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: Proportion of study wounds with complete wound healing by Week 12

Complete wound closure as defined by 100% epithelialisation of the wound surface (Gould 2019)

Outcome measures

Outcome measures
Measure	AQUACEL® Ag+ Extra™ n=107 Number of Wounds AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing AQUACEL® Ag+ Extra™: Wound treatment with AQUACEL® Ag+ Extra™ dressing	Cutimed® Sorbact® n=108 Number of Wounds Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing Cutimed® Sorbact®: Wound treatment with Cutimed® Sorbact® dressing
Effectiveness of AQUACEL® Ag+ Extra™ and Cutimed® Sorbact® on Wound Management	80 Number of Wounds	60 Number of Wounds

SECONDARY outcome

Timeframe: Up to 4 weeks

Population: Percent change in wound size at Week 4

Percent change in study wound area

Outcome measures

Outcome measures
Measure	AQUACEL® Ag+ Extra™ n=105 Number of Wounds AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing AQUACEL® Ag+ Extra™: Wound treatment with AQUACEL® Ag+ Extra™ dressing	Cutimed® Sorbact® n=108 Number of Wounds Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing Cutimed® Sorbact®: Wound treatment with Cutimed® Sorbact® dressing
Wound Healing Assessment	-62.66 Percent change in wound size Standard Deviation 43.54	-48.31 Percent change in wound size Standard Deviation 49.97

SECONDARY outcome

Timeframe: Up to 4 weeks

Population: Proportion of study wounds with satisfactory clinical progress defined as 40% reduction in study wound area at 4 weeks

Satisfactory clinical progress defined as 40% reduction in study wound area

Outcome measures

Outcome measures
Measure	AQUACEL® Ag+ Extra™ n=105 Number of Wounds AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing AQUACEL® Ag+ Extra™: Wound treatment with AQUACEL® Ag+ Extra™ dressing	Cutimed® Sorbact® n=108 Number of Wounds Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing Cutimed® Sorbact®: Wound treatment with Cutimed® Sorbact® dressing
Wound Progress Assessment	81 Number of Wounds Interval 69.11 to 85.17	70 Number of Wounds Interval 55.81 to 73.82

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Percent change in wound size at Week 12

Percent change in target wound area

Outcome measures

Outcome measures
Measure	AQUACEL® Ag+ Extra™ n=105 Number of Wounds AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing AQUACEL® Ag+ Extra™: Wound treatment with AQUACEL® Ag+ Extra™ dressing	Cutimed® Sorbact® n=108 Number of Wounds Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing Cutimed® Sorbact®: Wound treatment with Cutimed® Sorbact® dressing
Wound Change Assessment	-90.33 Percent change in wound size Standard Deviation 27.09	-67.22 Percent change in wound size Standard Deviation 55.13

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Proportion of subjects with AEs, SAEs, ADEs and Unanticipated Adverse Device Effects

Summary of the incidence of adverse events (AEs), device-related adverse events (ADEs) and serious device-related adverse events (SADEs)

Outcome measures

Outcome measures
Measure	AQUACEL® Ag+ Extra™ n=101 Participants AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing AQUACEL® Ag+ Extra™: Wound treatment with AQUACEL® Ag+ Extra™ dressing	Cutimed® Sorbact® n=102 Participants Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing Cutimed® Sorbact®: Wound treatment with Cutimed® Sorbact® dressing
Safety Assesment Any AE, subjects	11 participants	27 participants
Safety Assesment Any SAE, subjects	3 participants	6 participants
Safety Assesment Adverse Device Effects	1 participants	4 participants
Safety Assesment Serious Adverse Device Effect	0 participants	1 participants

Adverse Events

AQUACEL® Ag+ Extra™

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Cutimed® Sorbact®

Serious events: 6 serious events

Other events: 21 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	AQUACEL® Ag+ Extra™ n=101 participants at risk AQUACEL® Ag+ Extra™ is approved, needle-bonded nonwoven fabric layered and stitch-bonded wound dressing AQUACEL® Ag+ Extra™: Wound treatment with AQUACEL® Ag+ Extra™ dressing	Cutimed® Sorbact® n=102 participants at risk Cutimed® Sorbact® is approved, bacterial and fungi binding wound dressing Cutimed® Sorbact®: Wound treatment with Cutimed® Sorbact® dressing
Cardiac disorders Ischaemic heart disease	0.99% 1/101 • Number of events 1 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.	0.00% 0/102 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.
Gastrointestinal disorders Gastrointestinal bleeding	0.00% 0/101 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.	0.98% 1/102 • Number of events 1 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.
General disorders Death	0.00% 0/101 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.	0.98% 1/102 • Number of events 1 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.
Immune system disorders Allergic reaction to drug	0.00% 0/101 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.	0.98% 1/102 • Number of events 1 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.
Infections and infestations Cellulitis on left lower leg	0.00% 0/101 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.	0.98% 1/102 • Number of events 1 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.
Infections and infestations Chest infection	0.99% 1/101 • Number of events 1 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.	0.00% 0/102 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.
Infections and infestations UTI	0.99% 1/101 • Number of events 1 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.	0.98% 1/102 • Number of events 1 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.
Infections and infestations Unspecified local infection of skin and subcutaneous tissue	0.00% 0/101 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.	0.98% 1/102 • Number of events 1 • Adverse events (AEs), Serious Adverse events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (UADEs) and Device deficiencies were recorded throughout the study duration up to 84 days (±2 days). The definitions of each type of these events, instructions for causality assessment (i.e., determination of relationship of the event to the study device or study procedure), categories of severity (mild, moderate, or severe) of events, and procedure for monitoring and recording of events were provided in the study Protocol.

Other adverse events

Additional Information

Cristin Taylor, Senior Director, Medical Affairs, Advanced Wound Care

ConvaTec Inc.

Phone: 1-800-422-8811

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place