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Retrospective analysis of operating room irrigation using a low concentration chlorhexidine gluconate (CHG) 0.05% in sterile water for infection prevention after foot & ankle surgery
Address correspondence to: Calvin J.Rushing, DPM, AACFAS, Dallas Orthopedic and Shoulder Institute, 222 South Collins Road Suite 101, Sunnyvale, TX 75182.
Surgical site infection (SSI) after foot and ankle procedures adversely impacts both the quality and cost of health care delivery; increasing hospital length of stay, the number of re-operations, and readmission rate(s). The purpose of the present study was to assess the incidence of SSI in patients who underwent foot and ankle surgery with concurrent intraoperative lavage containing low concentration Chlorhexidine Gluconate (CHG) 0.05% in sterile water, @Irrisept. Seventy-three patients underwent reconstructive foot and ankle procedures utilizing @Irrisept for intraoperative lavage between September 2020 and October 2021 at a single institution. Medical record and charts were reviewed and the incidence of complications including postoperative erythema, delayed wound healing, dehiscence, and superficial/deep SSI, as well as reoperations, was recorded. Minimum follow-up for inclusion was at least 90 days, and procedures with concurrent vancomycin powder or prophylactic antibiotics postoperatively were excluded. Twelve complications occurred in 73 patients (16%): 1 erythema (1.4%), 4 delayed wound healing (5.5%), 1 dehiscence (1.4%), and 6 SSI's (8.2%). Of the SSIs, 2 were superficial and 4 deep; incidence rate of 2.7 and 5.5%. Six reoperations were performed in 4 patients for deep SSI; 3 (75%) had a previously documented history of SSI after orthopedic surgery. A strong association was identified between previous SSI after orthopedic surgery and SSI of the foot and ankle (p = 0.000271). The data suggests a low incidence of deep SSI in patients without a documented history of previous SSI after orthopedic surgery. Additional studies are warranted to validate the potential association identified.
The incidence of surgical site infection (SSI) after foot and ankle surgery ranges from 1.2 to 13.2%, exceeding the rates reported for hand surgery, total shoulder arthroplasty, total hip arthroplasty, and total knee arthroplasty.
Postoperative infection in a double-occupancy operating room. A prospective study of two thousand four hundred and fifty-eight procedures on the extremities.
Similar periprosthetic joint infection rates after and before a national infection control program: a study of 45,438 primary total knee arthroplasties.
Previous authors have attributed the unacceptably high SSI rate to a number of factors, which have been shown to increase hospital length of stay, re-operations, and readmission rates; adversely impacting both the quality and cost of health care delivery.
Bacterial skin contamination before and after surgical preparation of the foot, ankle, and lower leg in patients with diabetes and intact skin versus patients with diabetes and ulceration: a prospective controlled therapeutic study.
However, the efficacy of prophylactic antibiotics remains unsubstantiated, and side effects including allergic reaction(s) are not uncommon. Given that SSIs remain one of the most common complications after foot and ankle surgery, other alternative methods for mitigating postoperative SSI may exist.
Chlorhexidine is a cationic biguanide molecule most commonly used for surgical antisepsis in it's water soluble form, Chlorhexidine Gluconate (CHG). Chlorhexidine Gluconate's anti-microbial profile is broad, ranging from a number of gram-positive and gram negative bacteria (excluding bacterial spores), as well as fungi. At low concentrations, CHG is bacteriostatic, causing potassium ions to leak from the bacterial cell, inhibiting growth. At high concentrations, CHG is bactericidal, causing bacterial cytoplasm to lose its structure, leading to cell death.
@Irrisept (Irrimax Corporation, Gainesville, FL) is a low concentration Chlorhexidine Gluconate (CHG) 0.05% in sterile water, intended for intraoperative lavage/irrigation (Fig. 1). The 450cc single-use, manual, self-contained irrigation bottle is designed to afford control of the antimicrobial's delivery pressure, which is purported to effectively remove particulate, debris, and disrupt biofilm; without cytotoxicity, skin irritation, or allergic response. The purpose of the present study was to assess the incidence of SSI in patients who underwent foot and ankle surgery with concurrent intraoperative lavage containing low concentration CHG 0.05% in sterile water, @Irrisept; cases with concurrent use of topical vancomycin powder intraoperatively, or prophylactic antibiotics postoperatively were excluded.
Fig. 1@ Irrisept, 0.05% CHG in a 450cc single-use, manual, self-contained, irrigation bottle designed to afford control of the antimicrobial's delivery pressure.
Under Institutional Review Board (IRB) exemption, a retrospective case series was conducted on all patients who underwent reconstructive foot and ankle procedures with concurrent intraoperative lavage using a low concentration Chlorhexidine Gluconate (CHG) 0.05% in sterile water, by a single foot and ankle fellowship-trained surgeon from September 2020 and October 2021, at a single institution (Dallas Orthopedic and Shoulder Institute, Sunnyvale, Texas). Patients were initially identified via electronic medical records, which were cross-referenced with operative reports and clinical notes to ensure accuracy. The use of intraoperative vancomycin powder, postoperative prophylactic antibiotics, active infection, and incomplete medical records were considered exclusion criteria. Intraoperative vancomycin powder, and prophylactic antibiotics were used in conjunction with @Irrisept in some cases at the surgeons discretion; total ankle arthroplasty (TAA), ankle arthrodesis (AA), total talus replacement (TTR), Charcot reconstruction, and subtalar joint (STJ) distraction arthrodesis. At least 3 months of postoperative follow up was required, there was no other exclusion criteria.
Indications for surgery included elective and non-elective foot and ankle reconstructive procedures. Standard contraindications to reconstructive surgery were active infection, uncontrolled diabetes with neuropathy, severe peripheral vascular disease, neuromuscular dysfunction with paralysis, and severe osteopenia. Demographic data, and the incidence of complications including postoperative erythema, delayed wound healing, dehiscence, surgical site infection (SSI), as well as reoperations were recorded.
Surgical site infection was classified according to tissue depth and space; superficial involvement of skin and subcutaneous tissue, versus deep fascia/muscle. Although postoperative wound complications such as erythema, delayed wound healing and dehiscence and SSI can be difficult to differentiate and may represent a continuum, particularly in the foot and ankle, wound complications treated without the use of antibiotics or reoperation (s) were not defined as true superficial/deep SSI. In the present study, superficial SSI's were treated outpatient with oral antibiotics, local wound care, and in some cases, removal of the incisional sutures/staples. Deep SSI's were treated by reoperation, which included at least one formal incision and drainage procedure with concurrent intraoperative cultures to guide oral/intravenous antibiotics.
Study population
A total of 73 patients (28 elective, 45 non-elective) underwent reconstructive foot and ankle procedures met the inclusion between September 2020 and October 2021. The cohort included 30 men and 43 women, with 3 bilateral surgeries, 40 right-sided, and 30 left sided. The most common elective surgery was for adult acquired flatfoot deformity (AAFD) reconstruction, while the most common non-elective surgery was arthroscopically assisted open reduction internal fixation (AAORIF) of bi-malleolar and tri- malleolar ankle fractures. In 3 patients who underwent elective reconstruction procedures: AA, TTR, and STJ distraction arthrodesis, the surgeon elected to use @Irrisept alone rather than in conjunction with intraoperative vancomycin powder and prophylactic antibiotics; typically the preferred method. The 3 cases were included for the purposes of the study, all other cases of AA, TTR, and STJ distraction arthrodesis were excluded.
Mean age was 46 years (range, 15–86 years), with a mean body mass index of 32 (range, 21–53) kg/m2. Ten patients were diabetic (n = 10, 7%), and 14 had a history of previous tobacco use (n = 14, 19%). Two had a history of previous surgical site infection (n = 2, 3%). Reconstructive surgeries were categorized ankle, ankle/rearfoot, rearfoot, midfoot, forefoot, and combined procedures. Thirty-one surgeries (42%) were categorized as ankle, while 11 (15%) had ankle/rearfoot, 4 (6%) rearfoot, 3 (4%) midfoot, 16 (22%) forefoot, 8 (11%) combined ankle/foot surgery.
Statistical analysis
Descriptive statistics were used to report demographic data, complications, and reoperations. Fisher's Exact Test was used to identify any association between a history of previous infection from orthopedic surgery and complication/SSI after foot and ankle surgery. All statistical analysis was performed using R Studio Version 1.3.959, and all tests were considered significant with an alpha level of 0.05.
Results
Twelve complications occurred in 73 patients (16%): 1 erythema (1.4%), 4 delayed wound healing (5.5%), 1 dehiscence (1.4%), and 6 SSI's (8.2%). Of the 6 SSIs in 6 patients, 2 were superficial and 4 deep; representing an incidence rate of 2.7 and 5.5%, respectfully. All superficial SSI's occurred after elective cases; STJ distraction arthrodesis for calcaneal fracture malunion and 1st metatarsophalangeal joint arthrodesis with pan-metatarsal head resection. Both cases resolved with oral antibiotics (Cleocin, Ciprofloxacin) and wound care. The data is summarized in Table 1.
Six reoperations were performed in 4 patients for deep SSI. Three of the four (75%) patients had a history of previous SSI after orthopedic surgery not involving the foot and ankle. A strong association was identified between previous SSI after orthopedic surgery and SSI of the foot and ankle (p < 0.001). Two cases that underwent reoperation were non-elective reconstructive surgeries, and 2 elective. Three index surgeries (75%) were categorized as ankle (2 non-elective, 1 elective), while 1 (25%) was combined ankle/foot surgery. In all but 1 patient, intraoperative cultures were positive, isolating Multidrug resistant (MDR) Achromobacter and Pseudomonas aeruginosa, Propionibacterium Acnes, and Staphyloccosus lugendesis. All deep SSIs occurred within 4 weeks after the index procedure, ranging from postoperative week 3 to postoperative week 4. No deep SSI required amputation for definitive treatment. Aside from previous SSI after orthopedic surgery not involving the foot and ankle, no other associations were identified with SSI.
Discussion
The present study is the first to assess the incidence of SSI in patients who underwent foot and ankle surgery with concurrent intraoperative lavage containing low concentration CHG 0.05% in sterile water, @Irrisept; without concurrent use of topical vancomycin powder intraoperatively, or prophylactic antibiotics postoperatively. For this purpose, demographic data and incidence of complications including postoperative erythema, delayed wound healing, dehiscence, surgical site infection (SSI), as well as reoperations, for 73 patients (28 elective, 45 non-elective) that underwent reconstructive foot and ankle procedures at a single institution were assessed at a minimum follow-up of 90 days postoperative.
Overall, the data showed a low incidence of postoperative SSI in patients who underwent reconstructive foot and ankle surgery with intraoperative lavage containing low concentration CHG 0.05% in sterile water, @Irrisept; without concurrent use of topical vancomycin or prophylactic antibiotics. In total, six SSI's (8.2%) were recorded in 73 patients; 2 superficial and 4 deep; representing an incidence rate of 2.7 and 5.5%, respectfully. All cases of superficial SSI resolved with oral antibiotics and local wound care, while 6 reoperations were performed in 4 patients for deep SSI. Of the 4 patients who manifested a deep SSI, 3 had a documented history of previous SSI after orthopedic surgery outside the foot and ankle, which was strongly associated with SSI (p = 0.000271). No other associations were identified for purported risk factors. All deep SSI resolved following formal incision and drainage, culture directed IV antibiotics, and concurrent procedures; none required amputation for definitive treatment.
The primary limitations of the present study include the retrospective design, small cohort, and short-term follow-up. Furthermore, without any published comparative data, the potential association identified and conclusions drawn are preliminary. Additional studies are warranted to validate the potential association identified. Moreover, the involvement of a surgeon (C.J.R.) advisory board member for the Irrimax Corporation, the manufacturer of @Irrisept, naturally raises questions of biases. However, it should be noted that during the time of the study itself, the foot and ankle surgeon was not an advisory board member, nor a consultant for the Irrimax Corporation. Rather, the author was an independent researcher without any direct conflicts of interest, who was granted funding to retrospectively assess outcomes at a single institution for the purposes of assessing the utility of an intraoperative lavage containing low concentration CHG 0.05% in sterile water, in foot and ankle surgery.
The present study is the first to assess the utility of a low concentration CHG 0.05% as an intraoperative irrigation agent for the purpose of mitigating postoperative SSI after foot and ankle surgery. The data suggests a low incidence of deep SSI in patients without a documented history of previous SSI after orthopedic surgery; without concurrent use of intraoperative topical vancomycin powder, or prophylactic antibiotics postoperatively. In patients with a documented history of previous orthopedic SSI, it is recommended foot and ankle surgeons should consider additional measures to mitigate postoperative SSI. Additional studies are warranted to validate the potential association identified.
Declaration of Competing Interests
The author is currently a Medical Board Advisory Member for Irrimax Corporation. The author was not a board member during the course of data collection.
Informed patient consent
Retrospective data collection granted IRB exemption via Advarra.
References
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Dawson L.K.
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Baumhauer J.F.
Randomized, prospective study of the order of preoperative preparation solutions for patients undergoing foot and ankle orthopedic surgery.
Postoperative infection in a double-occupancy operating room. A prospective study of two thousand four hundred and fifty-eight procedures on the extremities.
Similar periprosthetic joint infection rates after and before a national infection control program: a study of 45,438 primary total knee arthroplasties.
Bacterial skin contamination before and after surgical preparation of the foot, ankle, and lower leg in patients with diabetes and intact skin versus patients with diabetes and ulceration: a prospective controlled therapeutic study.
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