Surgical Adhesive Drapes for Prevention and Healing of Wound Infections After Total Hip Arthroplasty

NCT02707302 | Completed DMC

• 1 other identifier: gztcm_001
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to support the rational use of iodophor-impregnated surgical adhesive drapes for preventing wound infections after total hip arthroplasty.

Conditions

Hip Replacement

Outcome Measures

Primary Outcomes (1)

• bacterial detection rate in the peri-wound tissue

  Time to bacterial culture

  48 hours

Secondary Outcomes (4)

• wound-healing time

  30 days after surgery

• wound-healing grade

  30 days after surgery

• pain evaluated by the Visual Analog Scale (VAS)

  6 months after surgery

• hip-joint function, evaluated by Harris hip score

  6 months after surgery

Study Arms (2)

Iodophor-impregnated adhesive drapes

EXPERIMENTAL

In the iodophor-impregnated adhesive drapes group, routine disinfection will be carried out and bacteria samples will be harvested 1 cm from the wound site using sterilized swabs prior to use of the surgical adhesive drapes, and again at the end of surgery before skin suturing, for preoperative bacterial culture. The packaging of the 3M™ iodophor-impregnated adhesive drapes will be opened and the aseptic adhesive drapes unfolded until the "stop" instruction. The adhesive drapes will then be pasted to the surgical wound and smoothed using an aseptic cloth, taking care to avoid air bubbles.

Device: Iodophor-impregnated adhesive drapes group

Iodophor-free adhesive drapes

EXPERIMENTAL

Patients in the iodophor-free adhesive drapes group will undergo the same procedures, but with iodophor-free drapes.

Procedure: Iodophor-free adhesive drapes group

Interventions

Iodophor-impregnated adhesive drapes group DEVICE

Odd-numbered patients are randomized to the iodophor-impregnated adhesive drapes group.3M™ loban™2 iodophor-impregnated adhesive drape(3M Company, St. Paul, Minnesota, USA) will be used at the surgical site in the iodophor-impregnated adhesive drapes group.

Iodophor-impregnated adhesive drapes

Iodophor-free adhesive drapes group PROCEDURE

Even-numbered patients are randomized to the iodophor-free adhesive drapes group. Iodophor-free aseptic adhesive drapes(3M Company, St. Paul, Minnesota, USA) will be used at the surgical site in the iodophor-free adhesive drapes group.

Iodophor-free adhesive drapes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years;
• either sex;
• able to tolerate anesthesia and surgery;
• hip-joint disease causing chronic discomfort and obvious joint-function disorders (including primary or secondary coxarthrosis, avascular necrosis of the femoral head, rheumatoid arthritis involving the hip joint, ankylosing spondylitis involving the hip joint, hip fracture (in older), tumor in the bone joint, and hemophilic arthritis);
• informed consent signed by patients, relatives or guardians and approved by the Hospital Ethics Committee.

You may not qualify if:

• allergy to antiseptics, such as iodophor;
• scheduled surgical area with red swelling and ulceration; positive bacterial cultures in the first detection;
• participation in other clinical trials within 30 days prior to recruitment; pregnancy;
• human immunodeficiency virus type I and/or hepatitis virus infection; neurogenic disease, any disease presenting with rapid bone destruction, poor muscular strength around the hip joint, or complicated by other organ diseases; systemic or local severe bacterial infection; poor surgical tolerance;
• emotional disturbance;
• inability to complete the clinical trial because of poor compliance;
• unsuitability for the clinical trial according to the researchers.

Sponsors & Collaborators

• Third Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine: lead

Study Officials

• Zhuo Wu, Master

  Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 14, 2016
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: January 1, 2012
• Last Updated: March 14, 2016

Record last verified: 2016-03