|Year : 2016 | Volume
| Issue : 1 | Page : 38-43
Iodophor-impregnated versus iodophor-free adhesive drapes for prevention and healing of wound infections after total hip arthroplasty: study protocol for a randomized controlled trial
Zhuo Wu, Zhi Wang, Zeng-bing Xia
Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine, Guangzhou, Guangdong Province, China
|Date of Web Publication||16-Mar-2016|
Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine, Guangzhou, Guangdong Province
Source of Support: None, Conflict of Interest: None
Background: Surgical adhesive drapes can be used to create an aseptic area around the operative wound to reduce bacterial infection. However, the efficacy of such drapes in preventing wound infection remains unclear. Few studies have examined the effects of iodophor-impregnated and iodophor-free adhesive drapes on bacteria in the deeper layers of the epidermis. We therefore plan to compare the effects of 3M iodophor-impregnated antibacterial adhesive drapes and 3M aseptic iodophor-free adhesive drapes on the incidence of wound infection and wound healing after total hip arthroplasty.
Methods/Design: We will perform a single-center, randomized, double-blinded, parallel-cohort controlled trial at the Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine, China. A total of 120 patients scheduled for total hip arthroplasty will be numbered according to their sequence of admission to the operating room and sex, in a single-blinded manner: men, nos. 1-60 and women, nos. 1-60. Odd-numbered patients will be operated on using iodophor-impregnated adhesive drapes, and even-numbered with iodophor-free adhesive drapes at the surgical site. Peri-articular tissue will be harvested for bacterial culture after disinfection and again between the end of surgery and prior to skin suturing. The primary outcomes will be Bacterial culture results, wound healing time and grade, The secondary outcomes will be pain score (Visual Analog Scale), Harris score, and X-ray results.
Discussion: The trial outcomes will support the rational use of iodophor-impregnated surgical adhesive drapes for preventing wound infections after total hip arthroplasty.
Trial registration: ClinicalTrial.gov identifier: NCT02707302.
Ethical approval: This study protocol acquired written approval from Ethics Committee of Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine, China (approval No. 2016-001-01), and will be performed in accordance with the Declaration of Helsinki developed by the World Medical Association.
Keywords: clinical trial; total hip arthroplasty; surgical thin film; wound infection; iodophor-impregnated adhesive drape; randomized controlled trial
|How to cite this article:|
Wu Z, Wang Z, Xia Zb. Iodophor-impregnated versus iodophor-free adhesive drapes for prevention and healing of wound infections after total hip arthroplasty: study protocol for a randomized controlled trial. Clin Trials Orthop Disord 2016;1:38-43
|How to cite this URL:|
Wu Z, Wang Z, Xia Zb. Iodophor-impregnated versus iodophor-free adhesive drapes for prevention and healing of wound infections after total hip arthroplasty: study protocol for a randomized controlled trial. Clin Trials Orthop Disord [serial online] 2016 [cited 2021 Jan 16];1:38-43. Available from: https://www.clinicalto.com/text.asp?2016/1/1/38/178854
| Background|| |
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 (Wu and Huang, 2013). Measures to prevent surgical-site infection currently include instrument sterilization, protection of an aseptic area, and use of prophylactic antibacterial drugs (Starr, 2008), while reduced surgical-wound size and use of iodophor-impregnated antibacterial adhesive drapes have also been proposed to reduce infection (Zhu, 2012).
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 (Fan et al., 1995; Wu and Huang, 2013), compared with iodophor-free adhesive drapes. Iodophor-impregnated adhesive drapes have been reported to reduce surgical-site infection in orthopedic surgery (Yoshimura et al., 2003). However, few studies have reported on the use of antibacterial surgical adhesive drapes in China, though Ling et al. (2013) 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 (Lu, 2015).
Although the effects of surgical adhesive drapes on wound infection have been extensively studied (Zheng et al., 2011; Nie et al., 2014), 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.
| Methods/Design|| |
A single-center, randomized, double-blinded, parallel-cohort controlled trial will be performed at the Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine, China. Patients meeting the inclusion criteria and scheduled to undergo total hip arthroplasty will be randomized into iodophor-impregnated adhesive drapes and an iodophor-free adhesive drapes groups [Figure 1].
Ethical considerations and informed consent
This study protocol has been approved by the Ethics Committee of the Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine, China (approval No. 2016-001-01). Each patient and their relatives/guardian(s) will be informed about participation in the trial by the researchers or researcher-authorized physicians. Written informed consent will be obtained from each patient. The study protocol will be performed in accordance with the Declaration of Helsinki developed by the World Medical Association.
A total of 120 patients scheduled to receive total hip arthroplasty at the Hospital of Bone Injury, Guangzhou University of Traditional Chinese Medicine, China, comply with the following 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). The exclusion criteria are: 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; or unsuitability for the clinical trial according to the researchers.
A total of 120 included patients will be numbered according to their sequence of admission to the operating room and sex, in a single-blinded manner: men, nos. 1-60 and women, nos. 1-60. Odd-numbered patients will be included in the iodophor-impregnated adhesive drapes group and even-numbered in the iodophor-free adhesive drapes group. 3M™ loban™2 iodophor-impregnated adhesive drape (3M Company, St. Paul, MN, USA) will be used at the surgical site in the iodophor-impregnated adhesive drapes group, and iodophor-free aseptic adhesive drapes in the iodophor-free adhesive drapes group. Surgeons, patients, outcome assessors, and statisticians will be blinded to grouping and the type of drapes used.
To ensure occupational protection and reduce the risk of patient wound infection, surgeons should undergo preoperative preparations including washing hands and wearing operating caps, face masks, and double-layered gloves. Under endotracheal anesthesia, all patients will be asked to lie in a lateral position, and the surgical area will be disinfected with 2% iodine tincture and deiodinated with 75% alcohol. Antibiotics should be used prior to surgery in all patients, and 0.5% skin disinfectant (Anerdian) should be used prior to wound closure. 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.
Details of the iodophor-impregnated and iodophor-free adhesive drapes to be used in the trial are shown in [Table 1].
Tissue samples will be collected in tubes after disinfection and prior to the use of surgical adhesive drapes, and again at the end of surgery, before skin suturing. The sample tubes will be shaken for 20 seconds on a vortex mixer, and 1.0 mL of the sample will be inoculated onto a sterilized flat plate using an aseptic pipette, with each sample being plated on two separate plates. Nutrient agar (45-48°C, 15-18 mL) will be gradually added to each flat plate. Once the nutrient agar has solidified, the flat plates will be incubated for 48 hours at 36 ± 1°C and the number of bacterial colonies will then be calculated.
The primary outcome measures will be: bacterial detection rate in the peri-wound tissue; and wound-healing time and grade (Zhang, 2006), where 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.
The secondary outcome measures will be: pain evaluated by the Visual Analog Scale (VAS) (Price et al., 1983); hip-joint function, evaluated by Harris hip score (Harris, 1969); and X-ray examination.
The timing of the trial outcome assessments are shown in [Table 2].
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 with 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.
All data will be analyzed statistically using SPSS 10.0 software. Quantitative baseline data will be compared using two-sample t-tests and Mann-Whitney U tests, and qualitative data using chi-square 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 chi-square tests. A level of P < 0.05 will be considered statistically significant.
| Discussion|| |
Antibacterial surgical adhesive drapes are routinely used during surgery in developed countries in Europe and America, and both the British National Institute for Health and Care Excellence guidelines and the updated version of the American Centers for Disease Control Surgical Site Infection guidelines recommend their use to help prevent surgical site infection (Alexander et al., 2011). Since 1 August 2012, Administrative Measures for the Clinical Use of Antibacterial Drugs have been put into practice. In China, the use of antibacterial drugs have been limited. It is hoped that the use of antibacterial adhesive drapes may become generalized, given the need to develop measures to prevent surgical site infection in the antibiotic era.
The surgical adhesive drapes used in this trial show strong viscosity, which ensures no shedding during surgery and no residual gel after their removal. Iodophor has broad-spectrum antibacterial activity and causes little skin allergy (Wu and Huang, 2013). Modified iodophor-impregnated adhesive drapes have been widely used in surgery because the iodophor can be stably released from the iodophor-impregnated polyester film to maintain its antibacterial activity and reduce bacterial colonization of the surgical site skin, thus exerting a mild and persistent sterilizing effect.
To ensure the accuracy of bacterial cultures in the current study, the wound skin will be swabbed with an aseptic cotton bud soaked in physiological saline prior to taking skin samples before and after removal of the surgical adhesive drapes for 72-hour bacterial culture. It is expected that the trial outcomes will support the rational and general clinical use of iodophor-impregnated antibacterial adhesive drapes during the perioperative stage of total hip arthroplasty.
This trial was completed between January 2009 and January 2012. The preliminary trial results showed that (1) surgical-site tissue harvested from the iodophor-impregnated and iodophor-free adhesive drapes groups prior to the use of surgical adhesive drapes and after disinfection grew aseptically. (2) Bacterial cultures were performed in both groups after removal of the surgical drapes at the end of surgery and prior to skin suture [Table 3]. The wound healing time and conditions for these two groups are shown in [Table 4]. Surgical wound healing in patients with positive and negative bacterial cultures in the iodophor-free adhesive drape group is shown in [Table 5]. There was a significant difference in surgical wound healing between patients with positive and negative bacterial culture outcomes (P < 0.01).
|Table 3: Bacterial culture outcomes at the time between the end of surgery and skin suture|
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|Table 5: Wound healing in bacteria-positive versus bacteria-negative conditions in the iodophor-free adhesive drape group|
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Conflicts of interest
ZW, the first atuhor, conceived and designed this study protocol. ZW, the second atuhor, and ZBX wrote the paper. All authors read and approved the final version of this paper.
This paper was screened twice using CrossCheck to verify originality before publication.
This paper was double-blinded and stringently reviewed by international expert reviewers.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]