Diabetes, Lymphedema, Morbid Obesity, Orthopedic Disorder
Conditions
Brief 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.
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.
Interventions
DEVICEAvance Solo
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.
OTHEROptifoam
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.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Healing Complication | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cellulitis Complications | 90 days | Incisional complication as assessed by number of cellulitis complications |
| Number of Abscess Complications | 90 days | Incisional complication as assessed by number of abscess complications |
| Number of Suture Abscess Complications | 90 days | Incisional complication as assessed by number of suture abscess complications |
| Number of Seroma Complications | 90 days | Incisional complication as assessed by number of seroma complications |
| Number of Skin Necrosis Complications | 90 days | Incisional complication as assessed by number of skin necrosis complications |
| Number of Hematoma Complications | 90 days | Incisional complication as assessed by number of hematoma complications |
| Pain During Dressing Changes | 90 days | Patient reported as none, mild, moderate, or severe |
| Patient Satisfaction | 90 days | Patient Satisfaction Question that the patient will rank on a min/max scale of 0 to 7, higher score indicates higher satisfaction |
| Number of Periwound Edema Complications | 90 days | Incisional complication as assessed by number of periwound edema complications |
Countries
United States
Participant flow
Recruitment details
Recruitment began 6/1/22, with first enrollment on 7/12/22. Recruitment continued until study was terminated on 5/1/23.
Participants by arm
| Arm | Count |
|---|---|
| Negative Pressure Wound Therapy Negative pressure to the incision site and managing exudate generated by the incision.
Avance Solo: 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. | 12 |
| Optifoam 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
Optifoam: 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. | 8 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Active arm terminated; trial was ended. | 3 | 8 |
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Lack of Efficacy | 6 | 0 |
Baseline characteristics
| Characteristic | Optifoam | Total | Negative Pressure Wound Therapy |
|---|---|---|---|
| Age, Continuous | 71 years | 64 years | 58 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 7 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 13 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Female | 4 Participants | 12 Participants | 8 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 8 |
| other Total, other adverse events | 3 / 12 | 0 / 8 |
| serious Total, serious adverse events | 0 / 12 | 0 / 8 |
Outcome results
Primary
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)
Time frame: 21 days
Population: Data not collected. Study terminated before endpoint data collection.
Secondary
Number of Abscess Complications
Incisional complication as assessed by number of abscess complications
Time frame: 90 days
Population: Data not collected. Study terminated before endpoint data collection.
Secondary
Number of Cellulitis Complications
Incisional complication as assessed by number of cellulitis complications
Time frame: 90 days
Population: Data not collected. Study terminated before endpoint data collection.
Secondary
Number of Hematoma Complications
Incisional complication as assessed by number of hematoma complications
Time frame: 90 days
Population: Data not collected. Study terminated before endpoint data collection.
Secondary
Number of Periwound Edema Complications
Incisional complication as assessed by number of periwound edema complications
Time frame: 90 days
Population: Data not collected. Study terminated before endpoint data collection.
Secondary
Number of Seroma Complications
Incisional complication as assessed by number of seroma complications
Time frame: 90 days
Population: Data not collected. Study terminated before endpoint data collection.
Secondary
Number of Skin Necrosis Complications
Incisional complication as assessed by number of skin necrosis complications
Time frame: 90 days
Population: Data not collected. Study terminated before endpoint data collection.
Secondary
Number of Suture Abscess Complications
Incisional complication as assessed by number of suture abscess complications
Time frame: 90 days
Population: Data not collected. Study terminated before endpoint data collection.
Secondary
Pain During Dressing Changes
Patient reported as none, mild, moderate, or severe
Time frame: 90 days
Population: Data not collected. Study terminated before endpoint data collection.
Secondary
Patient Satisfaction
Patient Satisfaction Question that the patient will rank on a min/max scale of 0 to 7, higher score indicates higher satisfaction
Time frame: 90 days
Population: Data not collected. Study terminated before endpoint data collection.