NCT05427916

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes
• Morbid Obesity
• Lymphedema
• Orthopedic Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-12
• Primary completion: 2023-02-17
• Completion: 2023-02-17
• First posted: 2022-06-22
• Last updated: 2024-03-13
• Results posted: 2024-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study