Hip Replacement Clinical Trial
Official title:
Iodophor-impregnated Versus Iodophor-free Adhesive Drapes for Prevention and Healing of Wound Infections After Total Hip Arthroplasty
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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