Clinical trial NCT05427916: Closed Incision Negative Pressure Wound Therapy vs. Foam as Post Operative Dressing
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Morbid Obesity
Lymphedema
Orthopedic Disorder
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Healing Complication
timeFrame: 21 days
Secondary outcomes:
measure: Number of Skin Necrosis Complications
timeFrame: 90 days
measure: Number of Cellulitis Complications
timeFrame: 90 days
measure: Number of Abscess Complications
timeFrame: 90 days
measure: Number of Suture Abscess Complications
timeFrame: 90 days
measure: Number of Seroma Complications
timeFrame: 90 days
measure: Number of Periwound Edema Complications
timeFrame: 90 days
measure: Number of Hematoma Complications
timeFrame: 90 days
measure: Pain During Dressing Changes
timeFrame: 90 days
measure: Patient Satisfaction
timeFrame: 90 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Lauren Rodio
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: John C Lantis, MD
role: PRINCIPAL_INVESTIGATOR
References: