NCT02064270

Study to Compare Negative Pressure Wound Therapy or Standard Dressings After Orthopedic Surgery

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 526 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Wound of Knee
• Wound of Hip

Interventions

Type	Name	Description
DEVICE	Single-Use Negative Pressure Wound Therapy	Application of PICO Single-Use Negative Pressure Wound Therapy
DEVICE	Standard postsurgical dressings	Use of Standard postsurgical dressings

Timeline

• Start date: 2014-03-01
• Primary completion: 2017-09-07
• Completion: 2017-09-07
• First posted: 2014-02-17
• Last updated: 2018-04-17
• Results posted: 2018-04-17

Locations

1 site across 1 country: United States