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

NCT04621838 | Completed

• 1 other identifier: WD2018-Silicone-02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound

Keywords

Silicone Foams; Chronic wounds; Acute wounds

Outcome Measures

Primary Outcomes (3)

• Primary 1 Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the management of wound exudate.

  Success will be determined by no deterioration of the wound or peri wound skin. A relative score will be used to score maceration of zero (no maceration), one (minimal maceration), two (moderate maceration), and three (excessive maceration and need to withdraw patient from study.

  After each dressing change up to 6 weeks following application of dressing

• Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to Wound Healing progression.

  Success will be determined by no deterioration of the wound. The assessor will assess the wound size and the % tissue types within the wound.

  After each dressing change up to 6 weeks following application of dressing

• Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to the per wound skin conditions.

  Success will be determined by no deterioration of peri wound skin. The peri wound skin will be assessed for maceration and signs of inflammation. A relative score will be used to score maceration of zero (no maceration), one (minimal maceration), two (moderate maceration), and three (excessive maceration and need to withdraw patient from study). Success will be determined that over the evaluation an increased score would represent peri wound deterioration. This will be measured using VAS value (0= no erythema, redness and skin erosion and 10 = extensive erythema, redness and skin erosion).

  After each dressing change up to 6 weeks following application of dressing

Secondary Outcomes (9)

• Effectiveness of dressing removal of both the Silicone Foam and Silicone Lite dressing will assessed.

  After each dressing change up to 6 weeks following application of dressing

• Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to wound pain.

  After each dressing change up to 6 weeks following application of dressing

• Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to ease of use of the dressing.

  After each dressing change up to 6 weeks following application of dressing

• Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to conformability of the dressing.

  After each dressing change up to 6 weeks following application of dressing

• Effectiveness of both Silicone Foam and Silicone Lite dressing will assessed in regards to dressing contours to anatomical contours of major wound site.

  After each dressing change up to 6 weeks following application of dressing

Study Arms (1)

Assigned intervention.

EXPERIMENTAL

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.

Other: Assigned interventions.

Interventions

Assigned interventions. 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.

Assigned intervention.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, age 18 years or above. (Females must not be pregnant and if of reproductive age should be using contraception).
• Subjects who are able to understand and give informed consent to take part in the evaluation.
• 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.
• None to high levels of exudate

You may not qualify if:

• Patients who decline the invitation to take part.
• Patients who are known to be non-compliant with medical treatment,
• Patients who are known to be sensitive to any of the dressing components.
• Broken/ damaged or prone to blistering peri wound skin.
• 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.
• 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.)
• Life expectancy of \<6 months.

Sponsors & Collaborators

• Advanced Medical Solutions Ltd.: lead
• Cliniscience Sp.: collaborator

Study Sites (1)

Poradnia Chorób Naczyń Obwodowych MIKOMED

Lodz, 94-238, Poland

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Jacek Mikosiński, MD, PhD

  Poradnia Chorób Naczyń Obwodowych MIKOMED

  PRINCIPAL INVESTIGATOR

• Katarzyna Rybołowicz, MD,PhD

  Gabinet Ortopedyczny, Specjalistyczny Ośrodek Leczniczo-Badawczy,

  PRINCIPAL INVESTIGATOR

• Konrad Pańczak, MD,PhD

  NZOZ Twój Lekarz Kobierzyce,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: November 9, 2020
• Study Start: April 21, 2020
• Primary Completion: January 30, 2022
• Study Completion: February 28, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)