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

Not Applicable

Terminated

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Negative Pressure Wound Therapy	Avance Solo	Negative pressure to the incision site and managing exudate generated by the incision.
Optifoam	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Skin Necrosis Complications	90 days	Incisional complication as assessed by number of skin necrosis complications
Number of Seroma Complications	90 days	Incisional complication as assessed by number of seroma complications
Pain During Dressing Changes	90 days	Patient reported as none, mild, moderate, or severe
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 Hematoma Complications	90 days	Incisional complication as assessed by number of hematoma complications
Number of Suture Abscess Complications	90 days	Incisional complication as assessed by number of suture abscess complications
Number of Periwound Edema Complications	90 days	Incisional complication as assessed by number of periwound edema complications
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