Comparison of Negative Pressure Wound Therapy vs. Conventional Dressings for Prevention of Wound Complications After Revision THA

Rush

Status and phase: Completed; Phase 1

Conditions: Infection, Drainage

Treatments: Device: Negative Pressure Wound Therapy (NPWT); Device: Sterile Antimicrobial Dressings

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03321799

16111608

Details and patient eligibility

About

Wound complications and surgical site infections following revision total joint arthroplasty result in significant morbidity and cost. To the investigators knowledge, no prospective, randomized controlled trials have examined the rate of wound complications, infection, and reoperation following revision total hip arthroplasty when treated with negative pressure wound therapy (NPWT) versus sterile dressings. The investigators hypothesize that the rate of wound complications, infections, and subsequent procedures in patients undergoing revision THA treatment will demonstrate a statistically and clinically relevant decrease when using NPWT versus sterile dressing.

Full description

Wound complications and surgical site infections (SSI) following revision total joint arthroplasty result in significant morbidity and cost. Persistent incisional drainage following total joint arthroplasty (TJA) has been reported to occur in 1% to 3% of patients. Drainage persisting greater than 48 hours has been reported as a risk factor for the development of an acute periprosthetic joint infection (PJI), with each additional day of wound drainage increasing the infection risk by 29-42%. Consequently, continued wound drainage has been shown to potentially increase the economic burden through longer hospital stays and subsequent surgical procedures. To the investigators knowledge, no prospective, randomized controlled trials have examined the rate of wound complications, infection, and reoperation following revision total hip arthroplasty when treated with NPWT versus sterile dressings. The investigators hypothesize that the rate of wound complications, infections, and subsequent procedures in patients undergoing revision THA treatment will demonstrate a statistically and clinically relevant decrease when using NPWT versus sterile dressing. The investigators will utilize a prospective, randomized, controlled study design to assess the efficacy of negative pressure wound therapy (NPWT) on the rate of wound complications, surgical site infections (SSIs), and reoperations after revision total hip arthroplasty (THA). For 90 days after surgery, the wound complications, including wound dehiscence, prolonged drainage for >7 days postoperatively, hematoma formation, surgical site infection, or periprosthetic joint infection that requires postoperative interventions, and reoperation will be tracked.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients > 18 years of age undergoing a revision total hip arthroplasty procedure to include:
• Conversion of a prior open hip surgery (i.e. open reduction internal fixation of a proximal femur fracture) to a total hip arthroplasty
• Aseptic revision for a diagnosis of component loosening, osteolysis, or revision procedure for periprosthetic fracture that requires revision of a component of the THA prosthesis (excluded isolated open reduction internal fixation of the fracture or initial placement of a hemi- or total hip arthroplasty)
• Septic revision surgery including irrigation and debridement of a postoperative infection or hematoma, one-stage exchange for acute postoperative infection, explantation and placement of an antibiotic cement spacer
• Reimplantation of a THA following placement of an antibiotic-loaded cement spacer
• The incision can be closed primarily without muscle flaps or skin grafting
• Willingness to undergo randomization and return for all scheduled visits

Exclusion criteria

• Patients requiring a muscle flap or skin grafting for wound closure
• Pregnant or lactating female
• Known sensitivity to the study product components (adhesives, etc.)
• Allergy to silver

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 2 patient groups

Sterile Antimicrobial Dressings

Active Comparator group

Description:

Control group, current hospital standard. AQUACEL is left in place for 7 days unless it becomes saturated over 50%, which requires a premature dressing change.

Treatment:

Device: Sterile Antimicrobial Dressings

Negative pressure wound therapy (NPWT)

Experimental group

Description:

Experimental group. Negative pressure wound therapy bandage applied intra-operatively by a physician on the treatment team. The dressing will be removed after 7 days postoperatively, or if the battery power stops earlier.

Treatment:

Device: Negative Pressure Wound Therapy (NPWT)