Wound of Knee Clinical Trial
Official title:
Prospective Randomized, Controlled Study to Assess Prevention of Incision Healing Complications in Patients Undergoing Total Knee or Hip Arthroplasty, Treated With Either Negative Pressure Wound Therapy or Standard Dressings.
The aim of this study is to assess the prevention of incision healing complications in patients undergoing Total Knee Arthroscopy (TKA) and Total Hip Arthroscopy (THA) treated with either Single-Use Incisional NPWT (Negative Pressure Wound Therapy), or standard of care dressings.
Most surgical wounds heal by primary intention, meaning the wound edges are brought together,
or approximated, by some sort of mechanical means (sutures, staples, paper tape, surgical
glue or adhesive strips) to heal with minimal scar formation. National clinical guidelines
recommend that incisions are covered with a postsurgical cover dressing, for up to a period
of 48 hours, to help control postoperative bleeding, absorb exudate, provide mechanical
protection, help to reduce edema and provide protection from exogenous sources. Multiple
patient comorbidities, environmental factors and the type and length of surgery may elevate
certain groups of patients into a higher level of risk of developing a post-surgical
complication: calling for a higher degree of vigilance and postsurgical intervention.
Surgical complications include; wound dehiscence, infection (deep or superficial), hematomas,
seromas, tissue necrosis and delayed incision healing. Complication rates can range from 19%
in patients requiring open reduction and internal fixation (ORIF) of tibial plateau, pilon
and calcaneus fractures up to 50% in high energy trauma wounds. These complications can have
a high degree of morbidity for the patient and further sequelae may result in additional
surgical procedures or revisions, a lower functional status for the patient, an increased in
length of hospital stay (LOS) and a higher cost for the healthcare provider.
Traditional NPWT has been shown to be an effective adjunct therapy in the treatment of acute
and chronic wounds, but the emergence of incisional NPWT (iNPWT) and supporting evidence is
growing momentum. In vitro studies have shown that iNPWT may help to improve the stimulation
of blood flow, help manage exudate, help to reduce edema, provide a mechanical and
"splinting" effect on the incision and provide mechanical protection from the environment.
Its impact on the prevention or reduction of post-surgical incision complications is still in
its infancy, but recent studies have been encouraging and have demonstrated a statistically
significant reduction in infection and dehiscence in patients considered as high-risk
following severe skeletal trauma.
The aim of this study is to assess the prevention of incision healing complications in
patients undergoing TKA and THA treated with either Single-Use Incisional NPWT compared to
standard of care dressings.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT03548610 -
Efficacy and Safety of a Nanofat-seeded Biological Scaffold in Healing Lower Limb Surgical Defects
|
N/A | |
| Terminated |
NCT03788239 -
Wound Closure After Total Knee Replacement
|
N/A |