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

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2022

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

  • Device: 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.
  • Other: 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.

Arms, Groups and Cohorts

  • Experimental: Negative Pressure Wound Therapy
    • Negative pressure to the incision site and managing exudate generated by the incision.
  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • Healing Complications
    • 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)

Secondary Measures

  • Number of skin necrosis complications
    • Time Frame: 90 days
    • Incisional complication as assessed by number of skin necrosis complications
  • Number of cellulitis complications
    • Time Frame: 90 days
    • Incisional complication as assessed by number of cellulitis complications
  • Number of abscess complications
    • Time Frame: 90 days
    • Incisional complication as assessed by number of abscess complications
  • Number of suture abscess complications
    • Time Frame: 90 days
    • Incisional complication as assessed by number of suture abscess complications
  • Number of seroma complications
    • Time Frame: 90 days
    • Incisional complication as assessed by number of seroma complications
  • Number of periwound edema complications
    • Time Frame: 90 days
    • Incisional complication as assessed by number of periwound edema complications
  • Number of hematoma complications
    • Time Frame: 90 days
    • Incisional complication as assessed by number of hematoma complications
  • Pain during dressing changes
    • Time Frame: 90 days
    • Patient reported as none, mild, moderate, or severe
  • Patient Satisfaction
    • Time Frame: 90 days
    • Patient Satisfaction Question that the patient will rank on a min/max scale of 0 to 7, higher score indicates higher satisfaction

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Icahn School of Medicine at Mount Sinai
  • Provider of Information About this Clinical Study
    • Principal Investigator: John Lantis, Professor – Icahn School of Medicine at Mount Sinai
  • Overall Official(s)
    • John C Lantis, MD, Principal Investigator, Icahn School of Medicine at Mount Sinai
  • Overall Contact(s)
    • Denise Alabi, 212-523-5915, denise.alabi@mountsinai.org

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