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

Diabetes Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetes
• Lymphedema
• Morbid Obesity
• Musculoskeletal Diseases
• Obesity, Morbid
• Orthopedic Disorder

• NCT number: NCT05427916
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Status: Terminated
• Phase: N/A
• Start date: July 12, 2022
• Completion date: February 17, 2023