To Evaluate the Safety and Performance of the AMS ActivHeal Silicone Foam and the ActivHeal Silicone Foam Lite Dressing.

NCT ID: NCT04621838

Last Updated: 2022-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-21
• Study Completion Date: 2022-02-28

Brief Summary

To demonstrate the safety and performance of both AMS ActivHeal Silicone Foam and AMS ActivHeal Silicone Foam Lite dressings to both the patient and clinician in managing both chronic and acute wounds.

Detailed Description

This PMCF study has been set up to investigate and assess residual risks in relation to the CE-marked AMS ActivHeal Silicone Foam and Silicone Foam Lite dressing . The purpose of this study is primarily to collect clinical follow-up data on the AMS ActivHeal Silicone Foam and Silicone Foam Lite dressing , as CE-marking was based on equivalence. The data and conclusions obtained from this study will be used to provide clinical evidence of safety and effectiveness for the clinical evaluation process.

Conditions

Wound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Assigned intervention.

Silicone Foam Dressing. Silicone Foam Lite.

Subjects will undergo treatment of their chronic or acute wound as indicated in the instructions for use with Silicone Foam dressing and Silicone Foam Lite Dressing.

Group Type: EXPERIMENTAL

Assigned interventions.

Intervention Type: OTHER

Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use, with Silicone Foam Dressing and Silicone Foam Lite Dressing.

The patients will be evaluated at each dressing change over a six-week period (per Product) or until the wound is healed to extent that the use of the Silicone Foam and Silicone Foam Lite dressing is no longer indicated from the time that the patient has been recruited.

Interventions

Assigned interventions.

Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use, with Silicone Foam Dressing and Silicone Foam Lite Dressing.

The patients will be evaluated at each dressing change over a six-week period (per Product) or until the wound is healed to extent that the use of the Silicone Foam and Silicone Foam Lite dressing is no longer indicated from the time that the patient has been recruited.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Males or females, age 18 years or above. (Females must not be pregnant and if of reproductive age should be using contraception).

2. Subjects who are able to understand and give informed consent to take part in the evaluation.

3. No local or systemic signs of infection, including new pain or increasing pain, erythema, local warmth, swelling, purulent discharge, pyrexia (in surgical wounds, typically five to seven days after surgery), delayed wound healing, abscess or malodour.

4. None to high levels of exudate

Exclusion Criteria

1. Patients who decline the invitation to take part.

2. Patients who are known to be non-compliant with medical treatment,

3. Patients who are known to be sensitive to any of the dressing components.

4. Broken/ damaged or prone to blistering peri wound skin.

5. Presence of a clinically infected wound as determined by the presence of three or more of the following clinical signs: peri wound, erythema, pain between dressing changes, malodourous wound, abundant exudate, oedema, abscess, cellulitis, purulent discharge, discolouration, friable granulation tissue which bleeds easily.

6. Patients who have a current illness or condition which may interfere with wound healing in the last 30 days which may interfere with wound healing (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse.)

7. Life expectancy of <6 months.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniscience Sp.

UNKNOWN

Sponsor Role: collaborator

Advanced Medical Solutions Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacek Mikosiński, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Poradnia Chorób Naczyń Obwodowych MIKOMED

Katarzyna Rybołowicz, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Gabinet Ortopedyczny, Specjalistyczny Ośrodek Leczniczo-Badawczy,

Konrad Pańczak, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

NZOZ Twój Lekarz Kobierzyce,

Locations

Poradnia Chorób Naczyń Obwodowych MIKOMED

Lodz, , Poland

Countries

Poland

Other Identifiers

WD2018-Silicone-02

Identifier Type: -

Identifier Source: org_study_id