Trial Outcomes & Findings for A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds (NCT NCT02431741)

NCT ID: NCT02431741

Last Updated: 2017-04-25

Results Overview

Weekly Visual inspection of the wounds by the investigators.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: weekly, for 5 weeks
• Results posted on: 2017-04-25

Participant Flow

Participant milestones

Measure	Mepilex Transfer Ag Non controlled investigation Mepilex Transfer Ag
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds

Baseline characteristics by cohort

Measure	Mepilex Transfer Ag n=14 Participants Non controlled investigation Mepilex Transfer Ag
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment Czech Republic	14 participants n=5 Participants
Infections in the wound at baseline	14 participants n=5 Participants
Pain during dressing changes	14 participants n=5 Participants
Exudate handling	14 participants n=5 Participants
Presence of malodour	14 participants n=5 Participants
Presence of bleeding from tumor	14 participants n=5 Participants

PRIMARY outcome

Timeframe: weekly, for 5 weeks

Population: ITT population

Weekly Visual inspection of the wounds by the investigators.

Outcome measures

Measure	Mepilex Transfer Ag n=14 Participants Non controlled investigation Mepilex Transfer Ag
Infection in the Wound (Signs of Clinical Infection)	14 participants

Adverse Events

Mepilex Transfer Ag

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. Petr Arenberger

Faculty Hospital Kralovske Czech Republic

Phone: +420 267 16 11 11

Email: avemedica@email.cz

Results disclosure agreements

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