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

NCT03321799 | Completed Phase 1 FDA Device

• 1 other identifier: 16111608
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infection, Drainage

Outcome Measures

Primary Outcomes (1)

• Wound complications

  Wound complications within 90 days of a revision total hip arthroplasty include: wound dehiscence, prolonged drainage for \>7 days postoperatively, hematoma formation, surgical site infection, or periprosthetic joint infection that requires postoperative interventions (i.e. unplanned office visits, topical application of antibiotics or PO antibiotics, in-office wound debridement or removal of suture material, hematoma aspiration and drainage) or a return to the operating room/reoperation.

  90 days

Secondary Outcomes (2)

• Reoperation

  90 days

• Cost comparison

  90 days

Study Arms (2)

Sterile Antimicrobial Dressings

ACTIVE COMPARATOR

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.

Device: Sterile Antimicrobial Dressings

Negative pressure wound therapy (NPWT)

EXPERIMENTAL

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.

Device: Negative Pressure Wound Therapy (NPWT)

Interventions

Negative Pressure Wound Therapy (NPWT) DEVICE

A computer randomization system will be used on the day of surgery to allocate patients to either the conventional or NPWT dressing. Due to the nature of this study, blinding of patients and surgeons to their allocated cohort will not be possible.

Negative pressure wound therapy (NPWT)

Sterile Antimicrobial Dressings DEVICE

Control group, current hospital standard.

Sterile Antimicrobial Dressings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• 3M: collaborator

Study Sites (1)

Anne DeBenedetti

Chicago, Illinois, 60607, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Denis Nam, MD, MSc

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: October 26, 2017
• Study Start: April 28, 2017
• Primary Completion: March 14, 2024
• Study Completion: July 11, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

US (1)