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

  • STATUS
    Recruiting
  • days left to enroll
    78
  • participants needed
    60
  • sponsor
    Icahn School of Medicine at Mount Sinai
Updated on 14 July 2022

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.

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.

Details
Condition High Risk Surgical Incisions
Treatment Avance Solo, Optifoam
Clinical Study IdentifierNCT05427916
SponsorIcahn School of Medicine at Mount Sinai
Last Modified on14 July 2022

Eligibility

Yes No Not Sure

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
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