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

Primary Purpose

Hip Replacement

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iodophor-impregnated adhesive drapes group
Iodophor-free adhesive drapes group
Sponsored by
Third Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Iodophor-impregnated adhesive drapes

    Iodophor-free adhesive drapes

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    bacterial detection rate in the peri-wound tissue
    Time to bacterial culture

    Secondary Outcome Measures

    wound-healing time
    wound-healing grade
    Wound-healing grade I = excellent wound healing without adverse reactions; grade II = inflammation including red swelling, sclerosis, hematoma and hydrops of the skin, but no suppuration; and grade III = wound suppuration and need for wound incision and drainage.
    pain evaluated by the Visual Analog Scale (VAS)
    hip-joint function, evaluated by Harris hip score

    Full Information

    First Posted
    March 2, 2016
    Last Updated
    March 8, 2016
    Sponsor
    Third Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02707302
    Brief Title
    Surgical Adhesive Drapes for Prevention and Healing of Wound Infections After Total Hip Arthroplasty
    Official Title
    Iodophor-impregnated Versus Iodophor-free Adhesive Drapes for Prevention and Healing of Wound Infections After Total Hip Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    June 2009 (Actual)
    Study Completion Date
    January 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Third Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Surgical-site infections, including deep-layer and superficial-layer wound infections, are common complications after total hip arthroplasty. Surgical infections lead to poor wound healing, increased hospital days, increased patient suffering and distress, higher costs, and even life-threatening events. Wound infections after total hip arthroplasty result in local pain, joint displacement, and reduced joint function. Compared with common bacterial infections, bacteria in the deep layer of the epidermis after total hip arthroplasty adhere to the metal prosthesis and bone cement, and may thus escape the immune system because of a lack of blood supply. Furthermore, the immune response contributes to the formation of a protective mucus layer on the prosthesis surface, and bacteria in this mucus layer may be protected from antibiotic intervention. Preventing surgical-site infection is thus an important factor determining the success of total hip arthroplasty. Measures to prevent surgical-site infection currently include instrument sterilization, protection of an aseptic area, and use of prophylactic antibacterial drugs, while reduced surgical-wound size and use of iodophor-impregnated antibacterial adhesive drapes have also been proposed to reduce infection. Surgical adhesive drapes can create an aseptic area around the wound, thus reducing the bacterial content and infection incidence. Compared with conventional iodophor-free polyethylene adhesive drapes, iodophor-impregnated polyester surgical adhesive drapes are more breathable and scalable, show better compliance, and provide better skin adhesion. Iodophor-impregnated adhesive drapes attached to the sterilized surgical site can effectively inhibit intraoperative movement of bacteria, providing a persistent and effective protection against wound infection after total hip arthroplasty. Total hip arthroplasty involves a long operation and has a high risk of wound infection. Iodophor-impregnated adhesive drapes are recommended because the iodophor-impregnated viscose persistently releases iodine ions to help maintain aseptic skin throughout surgery. Iodophor-impregnated adhesive drapes have been shown to decrease the incidence of wound infection and show broad-spectrum antibacterial activity for several hours, unaffected by body fluids and blood, compared with iodophor-free adhesive drapes. Iodophor-impregnated adhesive drapes have been reported to reduce surgical-site infection in orthopedic surgery. However, few studies have reported on the use of antibacterial surgical adhesive drapes in China, though Ling et al. reported that they decreased the incidence of surgical-site infection. However, despite evidence suggesting that 3M iodophor-impregnated antibacterial adhesive drapes can reduce bacteria at the surgical site, prevent wound infection, and promote wound healing. Although the effects of surgical adhesive drapes on wound infection have been extensively studied, to the best of our knowledge, no clinical study has compared the effects of iodophor-impregnated and iodophor-free antibacterial adhesive drapes on wound infection caused by bacteria in the deep layer of the epidermis. We hypothesized that 3M iodophor-impregnated adhesive drapes would inhibit bacteria around the surgical wound and in the deep layer of the epidermis after total hip arthroplasty, and promote wound healing more effectively than 3M iodophor-free adhesive drapes. We aim to validate this hypothesis in a single-center, randomized, double-blinded, and controlled clinical trial. Data collection, preservation, and monitoring Data will be collected on paper case-report forms and summarized in a table. The written records will be transferred to an electronic format using a double-data entry strategy. The trial process will be monitored by professional clinical research associates will full access to all essential documents to ensure patient safety and complete clinical data, including compliance with the informed-consent procedure, and evaluation of primary endpoints and compliance. In addition to regular site visits, the clinical research associates will also communicate with the trial center via e-mail and phone. If any patient(s) withdraws from the trial, an intention-to-treat analysis of related records should be performed, otherwise the patient's records will be deleted. The reasons for patient withdrawal should be recorded in the medical records. Statistical analysis All data will be analyzed statistically using Statistical Product and Service Solutions 10.0 software. Quantitative baseline data will be compared using two-sample t-tests and Mann-Whitney U tests, and qualitative data using χ2 or Fisher's exact probability tests. Differences in VAS and Harris scores between the iodophor-impregnated and iodophor-free adhesive drapes groups will be evaluated by two-sample t-tests. Non-normally distributed data will be converted or comparisons of primary and secondary outcomes prior to and after interventions will be compared between the groups using two-sample t-tests. Bacterial detection rates in peri-wound tissue and grade I wound-healing rates between the two groups will be compared by χ2 tests. A level of P < 0.05 will be considered statistically significant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Replacement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Iodophor-impregnated adhesive drapes
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Iodophor-free adhesive drapes
    Arm Type
    Experimental
    Arm Description
    Patients in the iodophor-free adhesive drapes group will undergo the same procedures, but with iodophor-free drapes.
    Intervention Type
    Device
    Intervention Name(s)
    Iodophor-impregnated adhesive drapes group
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Iodophor-free adhesive drapes group
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    bacterial detection rate in the peri-wound tissue
    Description
    Time to bacterial culture
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    wound-healing time
    Time Frame
    30 days after surgery
    Title
    wound-healing grade
    Description
    Wound-healing grade I = excellent wound healing without adverse reactions; grade II = inflammation including red swelling, sclerosis, hematoma and hydrops of the skin, but no suppuration; and grade III = wound suppuration and need for wound incision and drainage.
    Time Frame
    30 days after surgery
    Title
    pain evaluated by the Visual Analog Scale (VAS)
    Time Frame
    6 months after surgery
    Title
    hip-joint function, evaluated by Harris hip score
    Time Frame
    6 months after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhuo Wu, Master
    Organizational Affiliation
    Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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