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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
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.
Lauren Rodio
New York, New York, United States
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
Number of Skin Necrosis Complications
Incisional complication as assessed by number of skin necrosis complications
Time frame: 90 days
Number of Cellulitis Complications
Incisional complication as assessed by number of cellulitis complications
Time frame: 90 days
Number of Abscess Complications
Incisional complication as assessed by number of abscess complications
Time frame: 90 days
Number of Suture Abscess Complications
Incisional complication as assessed by number of suture abscess complications
Time frame: 90 days
Number of Seroma Complications
Incisional complication as assessed by number of seroma complications
Time frame: 90 days
Number of Periwound Edema Complications
Incisional complication as assessed by number of periwound edema complications
Time frame: 90 days
Number of Hematoma Complications
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Incisional complication as assessed by number of hematoma complications
Time frame: 90 days
Pain During Dressing Changes
Patient reported as none, mild, moderate, or severe
Time frame: 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
Time frame: 90 days