Surgical WoundMATILDANCT05632276
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Performance and Safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive Dressings in the Management of Surgical and Traumatic Wounds
A study testing ConvaFoam in people with Surgical Wound and Trauma-related Wound, run by ConvaTec Inc. at 2 sites in United States.
Trial summary
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, performance and safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of surgical and traumatic wounds Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound, Trauma-related Wound
- What is being tested?
- ConvaFoam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jun 2023to 13 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and over
- Patients able and willing to provide informed consent
- Patients with Surgical wounds including incisional wounds including laparoscopic
- wounds and surgical wounds healing by secondary intention.
- Patients with Traumatic wounds
- Patients must be willing to attend visits as per schedule in protocol
Who cannot join
- Patients with known allergies to any of the materials used in the dressing
- Patients who require any oxidising agents such as hydrogen peroxide or hypochlorite solutions.
- Patients, who in the opinion of the investigator, is considered unsuitable for any other reason
- Patients with wounds showing signs of infection on presentation or not resolving with the use of antibiotics
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center
Boston, Massachusetts, 02218
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, performance and safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of surgical and traumatic wounds
Read the detailed description
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, performance and safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of surgical and traumatic wounds for up to 4 weeks
- Conditions
- Surgical Wound, Trauma-related Wound
- Being tested
- ConvaFoam
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConvaFoamDevice
Also called ConvaFoam Silicone, ConvaFoam Border, ConvaFoam Non Adhesive
ConvaFoam™ Border, ConvaFoam™ Non-Adhesive, and ConvaFoam™ Silicone dressings are designed to provide a moist wound healing environment. All participants will be assigned a dressing based upon clinical judgement for a maximum of 4 weeks with weekly assessments and dressing changes
| Study group | Role | What they receive |
|---|---|---|
| ConvaFoam dressings | Other | Participants wounds will be assessed and will be allocated ConvaFoam Border, Silicone or Non-Adhesive dressing based upon the investigator's clinical judgment. participants will receive a dressing as part of a protocol of care for up to a period of 4 weeks Receives: Device: ConvaFoam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate the efficacy of ConvaFoam ™ Border, ConvaFoam™ Non-Adhesive and ConvaFoam™ Silicone to manage the indicated acute wounds when used in accordance with the IFU
The efficacy will be measured by the dressings ability to manage exudate as demonstrated by:
Lack of strikethrough
Maintenance or improvement of peri-wound skin
Measured: 4 weeks
Secondary outcomes (2)
Demonstrate the performance of ConvaFoam™ Border, ConvaFoam™ Non-Adhesive and ConvaFoam™ Silicone to manage the indicated acute wounds when used in accordance with the IFU
Performance will be measured by:
Wound healing as anticipated by primary or secondary intention
Wear time
Atraumatic removal
Pain (pre application during application and on removal)
Dressing comfort (patient satisfied with dressing comfort, able to resume activities of daily living)
Ease of use
Ease of removal
Health Care Practitioner satisfaction
Measured: 4 weeks
Demonstrate the safety of, ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of the indicated acute wounds when used in accordance with the IFU.
Safety will be measured by:
Adverse reaction (including wound complications such as maceration, bleeding, blistering / protection of peri-wound edges / peri-wound skin integrity)
Device Malfunctions
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start8 Jun 2023
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A 4-week device intervention to demonstrate the efficacy, performance and safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of surgical and traumatic wounds
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerem Ozer, MD, Study chair, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632276
- Sponsor's protocol ID
- WC-22-440
- Acronym
- MATILDA
- Status last verified
- Apr 2024
- First submitted
- 9 Nov 2022
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ranire-Maguire M, Caprioli R, Taylor C, Rodger R, Thomas A, Oropallo A. Exudate management with a next-generation multilayered foam dressing in traumatic and surgical wounds: a prospective, multicentre study. J Wound Care. 2026 May 2;35(5):392-398. doi: 10.12968/jowc.2026.0048. Epub 2026 Apr 30.
PubMed 42060501
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Performance and Safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive Dressings in the Management of Surgical and Traumatic Wounds
- ClinicalTrials.gov ID
- NCT05632276
- Acronym / sponsor ID
- MATILDA / WC-22-440
- Conditions
- Surgical Wound, Trauma-related Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, performance and safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of surgical and traumatic wounds
Detailed description
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, performance and safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of surgical and traumatic wounds for up to 4 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A 4-week device intervention to demonstrate the efficacy, performance and safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of surgical and traumatic wounds
| Arm | Type | Receives |
|---|---|---|
| ConvaFoam dressings | Other | Device: ConvaFoamParticipants wounds will be assessed and will be allocated ConvaFoam Border, Silicone or Non-Adhesive dressing based upon the investigator's clinical judgment. participants will receive a dressing as part of a protocol of care for up to a period of 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18 years and over
- Patients able and willing to provide informed consent
- Patients with Surgical wounds including incisional wounds including laparoscopic
- wounds and surgical wounds healing by secondary intention.
- Patients with Traumatic wounds
Key exclusion criteria (4 listed)
- Patients with known allergies to any of the materials used in the dressing
- Patients who require any oxidising agents such as hydrogen peroxide or hypochlorite solutions.
- Patients, who in the opinion of the investigator, is considered unsuitable for any other reason
- Patients with wounds showing signs of infection on presentation or not resolving with the use of antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConvaFoamAlso: ConvaFoam Silicone, ConvaFoam Border, ConvaFoam Non AdhesiveConvaFoam™ Border, ConvaFoam™ Non-Adhesive, and ConvaFoam™ Silicone dressings are designed to provide a moist wound healing environment. All participants will be assigned a dressing based upon clinical judgement for a maximum of 4 weeks with weekly assessments and dressing changes | Device | ConvaFoam dressings |
Primary outcome
Demonstrate the efficacy of ConvaFoam ™ Border, ConvaFoam™ Non-Adhesive and ConvaFoam™ Silicone to manage the indicated acute wounds when used in accordance with the IFU
Time frame: 4 weeks
The efficacy will be measured by the dressings ability to manage exudate as demonstrated by: Lack of strikethrough Maintenance or improvement of peri-wound skin
2 secondary outcomes
Demonstrate the performance of ConvaFoam™ Border, ConvaFoam™ Non-Adhesive and ConvaFoam™ Silicone to manage the indicated acute wounds when used in accordance with the IFU
Time frame: 4 weeks
Demonstrate the safety of, ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of the indicated acute wounds when used in accordance with the IFU.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Derived from this study: PubMed 42060501Ranire-Maguire M, Caprioli R, Taylor C, Rodger R, Thomas A, Oropallo A. Exudate management with a next-generation multilayered foam dressing in traumatic and surgical wounds: a prospective, multicentre study. J Wound Care. 2026 May 2;35(5):392-398. doi: 10.12968/jowc.2026.0048. Epub 2026 Apr 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerem Ozer, MD study chair
Medical Director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ConvaFoam in people with Surgical Wound and Trauma-related Wound, run by ConvaTec Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate the efficacy of ConvaFoam ™ Border, ConvaFoam™ Non-Adhesive and ConvaFoam™ Silicone to manage the indicated acute wounds when used in accordance with the IFU (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05632276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.