NCT07436065

Sterile vs Clean Non-Sterile Wound Dressing in Orthopedic Surgery

Postoperative Orthopedic Wound Dressing Using Sterile Versus Clean Non-sterile Techniques At Hamad General Hospital. A Prospective Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hamad Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized interventional pilot study aims to compare the rate of significant Surgical Site Infection (SSI) within the six weeks after elective orthopedic surgery using sterile versus clean non-sterile glove postoperative dressing techniques.

Detailed description

Surgical site infections (SSIs) following orthopaedic surgeries is not uncommon. If an infection occurs, it may lead to debilitating results, increased re-operations, hospital stay, and healthcare costs. SSI was defined by the Centers for Disease Control and Prevention/ National Nosocomial Infections Surveillance system. The definition included superficial and deep SSI with an onset within 30 days and 12 months, respectively, after the operation. Because there is no current standard of care to use sterile or clean nonsterile technique for wound care and dressing following elective orthopaedic procedures, further studies are needed to determine which technique is more effective in preventing acute SSI. The sterile technique was defined in a systematic review by Kent by the use of sterile field, sterile gloves, and sterile instruments. Whereas clean technique implies the use of a clean procedure field, clean non-sterile gloves and ensuring that the gloves, field, and supplies are free of contamination. Some studies have compared the use of sterile and clean non-sterile techniques to determine the effect on wound infections in cutaneous surgical procedures and chronic wounds. One study reported the SSI rate of 2.02% and 4.6% in patients underwent contaminated laceration wound repair using sterile and clean non-sterile techniques, respectively. The incidence of infection was not significantly different between the two groups. A Systematic Review and Meta-analysis have concluded that there was no difference in the rate of infection between outpatient surgical procedures performed with sterile versus non-sterile gloves. Other studies concluded that each health care organization has to establish its own guidelines for wound care because the existing evidence base does not support the preferential selection of either technique. A prospective randomized controlled study had concluded that clean non-sterile gloves are not inferior to sterile gloves for minor skin excisions in general practice regarding SSI. To the best of the investigators knowledge, there are no studies available that have compared the rate of acute postoperative SSI between the use of sterile versus clean non-sterile gloves for wound care and dressing after knee arthroscopy +/- ACL reconstruction (infection rate is low (0.14%-1.7%) following ACL reconstruction) and simple fracture fixation . This pilot study aims to evaluate the rate of acute SSI following this elective orthopedic procedures in sterile versus clean non-sterile techniques. Hypothesis: No difference in the rate of SSI between the use of sterile or clean non-sterile techniques following knee arthroscopy +\\- ACL reconstruction and isolated fracture fixation for wound care and dressing. Method: The study will be designed as a prospective pilot study to compare the rate of acute SSI up to 6 weeks following knee arthroscopy, ACL reconstruction or simple isolated fracture fixation between the use of sterile versus clean non-sterile techniques for wound care and dressing. The main reason behind this design is that no previous studies reported the rate of acute SSI following the aforementioned procedures. All patients will be treated using the same postoperative protocol. Dressing will be changed once by the one specialist nurse practitioner on day 5 after the procedure. Patients will be assessed in the outpatient clinic on day 14 for dressing changes and for suture removal. The final assessment will be at the outpatient visit on week six postoperatively. Adult patients (age \>= 18) who will undergo clean knee arthroscopy, ACL repair or isolated fracture fixation at orthopaedic surgery ward of Hamad General Hospital will be screened for recruitment. Patients who meet the inclusion criteria and are willing to participate in the study will be asked to sign a consent form. Once a patient is eligible for recruitment, informed consent will be obtained. The randomization sequence will be generated beforehand and the allocated treatments will be in sealed opaque envelopes. A sealed envelope will be opened and the allocated treatment will consist of either dressing change with the use of sterile or clean non-sterile technique during the post-operative course. Neither patients nor the research team will be blinded for dressing type. Baseline variables that will be collected include: * Patient demographics * Type of elective orthopaedic procedure * Duration of the operation * Estimated blood loss * Number of dressing changes and which days * Preventive measure such as pre-op staph aureus decolonization, dental check-up, hair removal, nutrition status will be screened before the surgery. Postoperative wound dressing changes will be performed using sterile gloves in the sterile group and clean non-sterile gloves in the comparative group. Sterile instruments and aseptic field technique will be used in both groups. All dressings will be applied by a single trained orthopedic wound nurse. The first dressing change will be performed only on postoperative day five, with follow-up assessments at two and six weeks. All wounds will be dressed using Mepilex® Border Flex (7.5 × 7.5 cm). Hand hygiene follows World Health Organization guidelines, and wounds will be cleansed with Chlorhexidine prior to dressing application. Laboratory testing including white blood cell count, C-reactive protein and wound cultures were obtained if infection was suspected. Patients will be followed during the hospital stay, 2 weeks and 6 weeks after the procedure. At each follow-up visit, SSI indicators will be collected and laboratory tests will be done only for patient with high clinical suspicion of infection, as part of routine patient care. White blood cell count, c-reactive protein and wound culture will obtained in patient who have clinical indications of SSI. The investigators will document any other operative complications and re-operations or re-admission during the postoperative 6 weeks as well. Significant SSIs were assessed by investigators using a standardized wound scoring system: grade 0 indicated no or slight erythema, grade 1 indicated erythema ≤1 cm from the incision line not requiring antibiotics, grade 2 indicated erythema \>1 cm with or without edema requiring systemic antibiotics, and grade 3 indicated purulent discharge with requiring surgical debridement in addition to antibiotics. Grades 2 and 3 will be considered clinically significant SSI.

Conditions

• Surgical Site Infection (SSI)

Interventions

Type	Name	Description
PROCEDURE	Sterile Glove Dressing Technique	Postoperative wound dressing performed using sterile glove with standard aseptic technique
PROCEDURE	Clean Non-Sterile Glove Dressing Technique	Postoperative wound dressing performed using clean non-sterile glove with standard aseptic technique

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-12-14
• Completion: 2024-12-14
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Qatar