Closed Incision Negative Pressure Wound Therapy vs. Foam as Post Operative Dressing

Mount Sinai Health System

Status

Terminated

Conditions

Orthopedic Disorder

Diabetes

Lymphedema

Morbid Obesity

Treatments

Other: Optifoam

Device: Avance Solo

Study type

Interventional

Funder types

Other

Identifiers

NCT05427916

STUDY-22-00329

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.