DiabetesNCT05427916
Closed Incision Negative Pressure Wound Therapy vs. Foam as Post Operative Dressing
A study testing Avance Solo and Optifoam in people with Diabetes and Morbid Obesity, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The primary objective is to assess the frequency of a wound healing complication, in a closed incisional wound in a "high risk" surgical incision when treated with Negative Pressure Wound Therapy versus a highly absorbent antimicrobial post - operative absorbent dressing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Morbid Obesity, Lymphedema
- What is being tested?
- Avance Solo and Optifoam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2022to 17 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The patient must be at least 18 years of age.
- Males and females - provided they are not pregnant and if of reproductive age are using contraception.
- Have a closed surgical incision post-surgery/closure (<24 hours after).
- The patient is able to understand the evaluation and is willing to consent to the evaluation.
- Undergoing appropriate: wound "high risk" surgery.
- Foot and ankle surgery.
Show all 13Show fewer
- Vascular groin incision.
- Long leg vein harvest incision.
- Closed forefoot and major amputation surgery.
- Possibly: breast augmentation and reduction surgery.
- HIV and hepatitis positive patients will not be excluded from this study.
- Renal failure patients will not be excluded.
- Patient on metabolic agent, immunosuppressants, or steroid therapy will not be excluded from this study.
Who cannot join
- Incisions in excess of effective dressing pad size provided.
- Patients with a known history of poor compliance with medical treatment.
- Patients who have participated in this trial previously and who were withdrawn.
- Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with incision), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing).
- Incisions where daily inspection is required underneath the dressing.
- Incisions which have an infection which is not being treated with systemic antibiotics.
- Incisions which are actively bleeding.
- Exposure of blood vessels, organs, bone or tendon at the base of the reference incision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Evaluation of the Effect of Avance® Solo Negative Pressure Wound Therapy System or Optifoam® Gentle Post-Op Dressing on "High Risk" Closed Surgical Incisions; Freedom From Wound Complication Study
The primary objective is to assess the frequency of a wound healing complication, in a closed incisional wound in a "high risk" surgical incision when treated with Negative Pressure Wound Therapy versus a highly absorbent antimicrobial post - operative absorbent dressing.
Read the detailed description
A healing complication is defined as presence of at least one of the following conditions: infection (superficial or deep), dehiscence (partial, superficial, or deep), or delayed healing (incision not 100% closed within 7 days of the first surgical procedure), drainage form the wound after 96 hours post operatively.
The secondary objectives are to assess any changes in the following assessments of the surgical incision weekly over the treatment period:
- Surrounding skin condition
- Incision complications, infection or clinical signs of infection
- to assess the number and type of these complications individually including other postsurgical complications: skin necrosis, cellulitis, abscess, suture abscess, seroma, periwound edema or hematoma occurring within 21, 42, and 90 days postoperatively
- Pain during dressing changes
Assessment of the following at dressing changes:
- Duration/wear time
- Ease of use; difficulty with sleep
- Damage to surrounding skin on removal
- Assessment of re-epithelialization/closure
- Patient comfort during wear; ease of ambulation
- Conformability of dressing
- Exudate management
- Reasons for removal
To assess the overall comparison of Avance® Solo to the standard of care foam dressing.
- Conditions
- Diabetes, Morbid Obesity, Lymphedema, Orthopedic Disorder
- Being tested
- Avance Solo, Optifoam
- Medical subject headings
- Diabetes Mellitus, Obesity, Morbid, Lymphedema, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avance SoloDevice
Avance® Solo will include the collective description for a complete device capable of delivering negative pressure to the incision site and managing exudate generated by the incision.
OptifoamOther
Optifoam is a silicone backed foam that is conformable, with a border that is waterproof, flexible and breathable for increased comfort, with a wear time of up to seven days. It is a standard of care product that is given to patients for surgical wounds.
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Negative pressure to the incision site and managing exudate generated by the incision. Receives: Device: Avance Solo |
| Optifoam | Active comparator | This foam is standard of care and is currently stocked by the operating rooms at Mount Sinai hospital and indicated for use in high risk wounds Receives: Other: Optifoam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Healing Complication
Healing complications are defined as the presence of at least one of the following conditions: infection (superficial or deep), dehiscence (partial, superficial, or deep), or delayed healing (incision not 100% closed within 7 days of the first surgical procedure)
Measured: 21 days
Secondary outcomes (9)
Number of Skin Necrosis Complications
Incisional complication as assessed by number of skin necrosis complications
Measured: 90 days
Number of Cellulitis Complications
Incisional complication as assessed by number of cellulitis complications
Measured: 90 days
Number of Abscess Complications
Incisional complication as assessed by number of abscess complications
Measured: 90 days
Number of Suture Abscess Complications
Incisional complication as assessed by number of suture abscess complications
Measured: 90 days
Number of Seroma Complications
Incisional complication as assessed by number of seroma complications
Measured: 90 days
Number of Periwound Edema Complications
Incisional complication as assessed by number of periwound edema complications
Measured: 90 days
Number of Hematoma Complications
Incisional complication as assessed by number of hematoma complications
Measured: 90 days
Pain During Dressing Changes
Patient reported as none, mild, moderate, or severe
Measured: 90 days
Patient Satisfaction
Patient Satisfaction Question that the patient will rank on a min/max scale of 0 to 7, higher score indicates higher satisfaction
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start12 Jul 2022
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Why it stopped: Site decided not to continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Lantis, Icahn School of Medicine at Mount Sinai
- Investigators
- John C Lantis, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427916
- Sponsor's protocol ID
- STUDY-22-00329
- Status last verified
- Feb 2024
- First submitted
- 16 Jun 2022
- Last updated
- 13 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Evaluation of the Effect of Avance® Solo Negative Pressure Wound Therapy System or Optifoam® Gentle Post-Op Dressing on "High Risk" Closed Surgical Incisions; Freedom From Wound Complication Study
- ClinicalTrials.gov ID
- NCT05427916
- Acronym / sponsor ID
- STUDY-22-00329
- Conditions
- Diabetes, Morbid Obesity, Lymphedema, Orthopedic Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Site decided not to continue
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 22 Jun 2022 (actual)
- Results
- Posted 13 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess the frequency of a wound healing complication, in a closed incisional wound in a "high risk" surgical incision when treated with Negative Pressure Wound Therapy versus a highly absorbent antimicrobial post - operative absorbent dressing.
Detailed description
A healing complication is defined as presence of at least one of the following conditions: infection (superficial or deep), dehiscence (partial, superficial, or deep), or delayed healing (incision not 100% closed within 7 days of the first surgical procedure), drainage form the wound after 96 hours post operatively.
The secondary objectives are to assess any changes in the following assessments of the surgical incision weekly over the treatment period:
- Surrounding skin condition
- Incision complications, infection or clinical signs of infection
- to assess the number and type of these complications individually including other postsurgical complications: skin necrosis, cellulitis, abscess, suture abscess, seroma, periwound edema or hematoma occurring within 21, 42, and 90 days postoperatively
- Pain during dressing changes
Assessment of the following at dressing changes:
- Duration/wear time
- Ease of use; difficulty with sleep
- Damage to surrounding skin on removal
- Assessment of re-epithelialization/closure
- Patient comfort during wear; ease of ambulation
- Conformability of dressing
- Exudate management
- Reasons for removal
To assess the overall comparison of Avance® Solo to the standard of care foam dressing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Device: Avance SoloNegative pressure to the incision site and managing exudate generated by the incision. |
| Optifoam | Active comparator | Other: OptifoamThis foam is standard of care and is currently stocked by the operating rooms at Mount Sinai hospital and indicated for use in high risk wounds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The patient must be at least 18 years of age.
- Males and females - provided they are not pregnant and if of reproductive age are using contraception.
- Have a closed surgical incision post-surgery/closure (<24 hours after).
- The patient is able to understand the evaluation and is willing to consent to the evaluation.
- Undergoing appropriate: wound "high risk" surgery.
Key exclusion criteria (8 listed)
- Incisions in excess of effective dressing pad size provided.
- Patients with a known history of poor compliance with medical treatment.
- Patients who have participated in this trial previously and who were withdrawn.
- Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with incision), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing).
- Incisions where daily inspection is required underneath the dressing.
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 |
|---|---|---|
| Avance SoloAvance® Solo will include the collective description for a complete device capable of delivering negative pressure to the incision site and managing exudate generated by the incision. | Device | Negative Pressure Wound Therapy |
| OptifoamOptifoam is a silicone backed foam that is conformable, with a border that is waterproof, flexible and breathable for increased comfort, with a wear time of up to seven days. It is a standard of care product that is given to patients for surgical wounds. | Other | Optifoam |
Primary outcome
Number of Participants With Healing Complication
Time frame: 21 days
Healing complications are defined as the presence of at least one of the following conditions: infection (superficial or deep), dehiscence (partial, superficial, or deep), or delayed healing (incision not 100% closed within 7 days of the first surgical procedure)
9 secondary outcomes
Number of Skin Necrosis Complications
Time frame: 90 days
Number of Cellulitis Complications
Time frame: 90 days
Number of Abscess Complications
Time frame: 90 days
Number of Suture Abscess Complications
Time frame: 90 days
Number of Seroma Complications
Time frame: 90 days
Number of Periwound Edema Complications
Time frame: 90 days
Number of Hematoma Complications
Time frame: 90 days
Pain During Dressing Changes
Time frame: 90 days
Patient Satisfaction
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
John C Lantis, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avance Solo and Optifoam in people with Diabetes and Morbid Obesity, run by Icahn School of Medicine at Mount Sinai at 1 site 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 13 inclusion and 8 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: stopped early, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 13 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Healing Complication (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2024.