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Comparison of Soap and Antibiotic Solutions for Irrigation of Lower-Limb Open Fracture WoundsA Prospective, Randomized Study
Jeffrey O. Anglen, MD1
1 Department of Orthopaedics, Indiana University, 541 Clinical Drive, Suite 600, Indianapolis, IN 46202-5111. E-mail address: janglen@iupui.edu
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A commentary is available with the electronic versions of this article, on our web site (www.jbjs.org) and on our quarterly CD-ROM (call our subscription department, at 781-449-9780, to order the CD-ROM).
Note: The author thanks Dr. Eric Malicky and Dr. Jim Edwards for their help with the execution of this study; Paula Harrison, Tabitha Stith, Linda Landry, Kim Suppes, and Katy Goss for their data collection; Diane Anglen and Elena Penn for their work in organizing and executing the intraoperative components of the study; and Dr. Barry Gainor, Dr. Gordan Christensen, and Dr. W. Andrew Simpson for their collaboration in the laboratory investigations of surfactant irrigations.
Investigation performed at the Department of Orthopaedics, University of Missouri, Columbia, Missouri

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2005 Jul 01;87(7):1415-1422. doi: 10.2106/JBJS.D.02615
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Abstract

Background: Irrigation of open fracture wounds is a commonly performed procedure, and irrigation additives have been used in an attempt to reduce the risk of infection. In vitro and animal studies have suggested that irrigation with detergent solution is more effective than irrigation with a solution containing antibiotic additives. This study was performed to compare the efficacy of those two solutions in the treatment of open fractures in humans.

Methods: Adult patients with an open fracture of the lower extremity were prospectively randomized to receive irrigation with either a bacitracin solution or a nonsterile castile soap solution. The patients were followed clinically to assess for the development of infection, healing of the soft-tissue wound, and union of the fracture.

Results: Between 1995 and 2002, 400 patients with a total of 458 open fractures of the lower extremity were entered into the study. One hundred and ninety-two patients were assigned to the bacitracin group (B), and 208 were assigned to the castile soap group (C). Outcomes were available for 171 patients with a total of 199 fractures in group B and 180 patients with a total of 199 fractures in group C. The mean duration of follow-up was 500 days. There was no difference between groups B and C in terms of gender, the Gustilo-Anderson grade of the open fracture, the time between the injury and the irrigation, smoking, or alcohol use. There were significant differences in the mean age (thirty-eight compared with forty-two years, p = 0.01), duration of follow-up (560 compared with 444 days, p = 0.01), prevalence of hypotension (23% compared with 14%, p = 0.04), and duration of treatment with intravenous antibiotics (eleven compared with nine days, p = 0.02). An infection developed at thirty-five (18%) of the 199 fracture sites in group B and at twenty-six (13%) of the 199 fracture sites in group C. This difference was not significant (p = 0.2). Bone-healing was delayed for forty-nine (25%) of the 199 group-B fractures and forty-six (23%) of the 199 group-C fractures (p = 0.72). Wound-healing problems occurred in association with nineteen group-B fractures (9.5%) and eight group-C fractures (4%). This difference was significant (p = 0.03).

Conclusions: Irrigation of open fracture wounds with antibiotic solution offers no advantages over the use of a nonsterile soap solution, and it may increase the risk of wound-healing problems.

Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

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    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Jeffrey O. Anglen, M.D.
    Posted on December 02, 2005
    Dr. Anglen responds to Dr. John
    Indiana University, Dept. of Orthopaeidcs, 541 Clinical Drive, Suite, 600, Indianapolis, IN 46202

    I thank Dr. John for his interest in the paper, and I agree that the pathogenesis of infection in any particular case is multifactorial. I am not sure, however, that I agree with his opinion that the "single most important factor" in preventing infection after open fracture is irrigation with copious amounts of fluid. Certainly our study did not address that issue in quite that fashion - both groups received the same amount of fluid by protocol. Personally, I think adequate sharp tissue debridement is as important as irrigation, and the case could be made for the use of antibiotics as well. Certainly all components are important, and the absence of any aspect of open fracture treatment (irrigation, debridement, antibiotics, stability) increased the risk of infection.

    Joby John
    Posted on November 17, 2005
    Comparison of Soap & Antibiotic Solutions for Irrigation of Lower-Limb Open Fracture Wounds.
    Royal Shrewsbury Hospital, UK

    To The Editor:

    I read with great interest the article by Anglen (1)on the use of antibiotics and antiseptics in washing open fractures. The effect of a single variable when infection is multivariate in pathogenesis is very difficult to assess. Amidst all the intricacies and questions concerning the conclusions reached by the author, I believe that the most important message is that the single most important factor that decreases infections in open fracture is dilution with copious amounts of fluid.

    The message is especially important in disadvantaged regions of the world where the cost implications of preparing irrigating fluids is enormous. I believe the authors must be heartily congratulated for presenting this universal and abiding message.

    References:

    1.Jeffrey O. Anglen Comparison of Soap and Antibiotic Solutions for Irrigation of Lower-Limb Open Fracture Wounds. A Prospective, Randomized Study J Bone Joint Surg Am 2005; 87: 1415-1422 ]

    Imre Loefler
    Posted on August 30, 2005
    Plain Water for Irrigation of Open Wounds
    The Nairobi Hospital Proceedings, Nairobi, KENYA

    To the Editor:

    Doctor Anglen's study(1) should be repeated comparing tap water with soap, or, for that matter, any other solution.

    Tap water, in quantities delivered from a hose or a showerhead, and followed by soaking, is the best method available for debriding and cleaning open wounds of any kind. My patients with open wounds are treated with copious tap water irrigation; the wounds heal or can be sutured, reconstructed, and grafted.

    I have used this method in many hospitals in East African countries by preference and not only in situations where I had no alternative.

    I recognize that a tap water study in a first world country would have to take cognizance of an important confounder--chlorine in the water supply. However, I have used tap water in African towns and water from boreholes or wells from the Nile,the Zambezi, and the Great Lakes, and I believe I have pretty well excluded confounders with respect to whatever those waters may contain.

    Finally, I would point out that The International Red Cross recommends soaking of wounds and hosing with plain water.

    Sincerely, Imre Loefler References: <_1 /> Anglen,J.O., "COMPARISON OF SOAP AND ANTIBIOTIC SOLUTIONS FOR IRRIGATION OF LOWER-LIMB OPEN FRACTURE WOUNDS," JBJS-A,2005;87:1415-1422.

    Jeff O. Anglen
    Posted on August 01, 2005
    Dr. Anglen responds to Dr. Todkar
    Indiana University Department of Orthopaedics

    I thank Dr. Todkar for his interest in my paper and this topic. I agree entirely with his opinion that some antiseptics, such as hydrogen peroxide, may be detrimental to open fracture wound healing. I would caution against use of any antiseptic solution in open fracture wounds, because of the damage done to host tissues and immune cells. I also agree that irrigation of open fracture wounds is a poor method of antibiotic delivery, and for that reason, the practice doesn't make much sense.

    It is perhaps a mistake to state that I concluded that "wounds heal better with soap solutions that with antibiotic solutions". What I did was to report the observation that, in this particular group of randomized patients with open fractures of the lower extremity, patients irrigated with soap solution had a statistically significant reduction in wound healing problems compared with those who recieved antibiotic solution irrigation. Whether or not this finding will hold true for all wounds in all settings is unknown and we will have to await further research.

    Jeff Anglen, M.D.

    Jeff O. Anglen
    Posted on July 24, 2005
    Dr. Anglen responds to Drs. Sambandam and Gul
    Indiana University, Indianapolis, IN 46202-5111

    I thank Drs. Sambandam and Gul for their kind comments regarding my paper and for the attention and interest they have given to the work. I will try to respond to their comments.

    They have stated in their letter that I “derived a statistical conclusion that the antibiotic irrigation is the causative factor for poor wound healing”. That is not exactly correct. What I did was to report the observation that wound healing problems were significantly more frequent in patients randomized to the antibiotic irrigation. This association does not prove causation.

    There are at least 4 possible explanations. First, despite the low p value, there is some chance, although unlikely, that the difference between the groups occurred randomly, and does not reflect a true difference. Larger studies will be needed to confirm that the difference is real.

    Second, there is the possibility that antibiotic solution was detrimental to wound healing. As all clinicians know, antibiotics do have substantial toxicities, as in the well-known nephrotoxicity of aminoglycosides. During the first World War, it is reported that wounds sprinkled with sulfanilamide powder suffered necrosis and higher infection rates due to caustic toxicity of the antibiotic.

    Third, there exists the possibility that the soap solution was somehow beneficial to wound healing. Fourth, it is possible that despite randomization and despite the fact that no clinically significant differences between the two groups were found, they did actually differ in some way that would predispose the antibiotic group to wound problems. Further study may clarify the causation of the observed association.

    Because causation of this effect is not clear, I carefully stated the conclusion in the abstract: “Irrigation of open fracture wounds with antibiotic solution offers no advantages over the use of a nonsterile soap solution, and it MAY increase the risk of wound-healing problems.” In the paper, I conclude that “the use of a nonsterile liquid soap additive to irrigate open fracture wounds is at least as effective as the use of bacitracin.”

    The correspondents suggest that I have not “tried to find out the correlation (either pearson or chi square) between poor wound healing and other contributing factors.” I would refer them to the 3rd paragraph under Outcomes in the Results section where it states: “Wound-healing problems were associated with skin loss (p = 0.007) but not with the Gustilo-Anderson grade (p = 0.166), gross contamination (p = 0.146), muscle (p = 0.282) or bone (p = 0.512) loss, age group (p = 0.343), hypotension (p = 0.189), or tobacco use (p = 0.107).” These p values were generated with the use of a Pearson test as mentioned in the Materials section.

    Yours truly,

    Jeffrey Anglen

    MANOJ TODKAR
    Posted on July 08, 2005
    IRRIGATION OF OPEN FRACTURE WOUNDS
    NUFFIELD ORTHOPAEDIC CENTRE,OXFORD, UK

    To the Editor:

    I read the article by Dr. Anglen, "Comparison of Soap and Antibiotic Solutions for Irrigation of Lower-Limb Open Fracture Wounds. A Prospective, Randomized Study" with great interest. The topic is of interest to all the orthopaedic surgeons dealing with open fractures in their practice.

    We have used a number of different solutions - saline, soap, antibiotic, chlorhexidine, betadine, hydrogen peroxide, etc. The most important factor, in my view, is use of copious pulse lavage which mechanically removes the debris and bacteria in an open wound. It has been suggested that at least a few litres of saline should be used for irrigation rather than hydrogen peroxide because in some open wounds, debris is driven deep into tissues with the foaming action of hydrogen peroxide.

    As the antibiotic solutions are in contact with the tissues for a very short time during irrigation, it is difficult to ascertain their efficacy. The author has concluded that wounds healed better with soap solutions rather than antibiotic solutions. It is, in fact, very difficult to draw such conclusions as a large number of factors determine the healing of wounds associated with open fractures.

    Senthil Nathan Sambandam
    Posted on July 05, 2005
    Antibiotic irrigation increases wound complications. Is it a valid statistical conclusion?
    University Hospital of North Staffordshire

    To the Editor:

    We would like to make some comment about the article titled, "COMPARISON OF SOAP AND ANTIBIOTIC SOLUTIONS FOR IRRIGATION OF LOWER-LIMB OPEN FRACTURE WOUNDS". First, we would like to congratulate the author for this excellent prospective randomised study. The author has even stratified the confounding variables like the grade of open injury before randomising. Hence, we think this article presents an important level of evidence in the wound management of open fracture. However, there are some areas in the article which we would ask the author to clarify so that readers will acquire even more valuable information.

    The study compared group B and group C and found that there was no significant difference between both groups with regards to most of the variables that can possibly contribute to poor wound healing. The author also compared the cohort of poor wound healing in group B to the cohort of poor wound healing in group C. On the basis of univariate analysis the author says there was no significant difference between these cohorts with respect to age, level of fracture, grade of open fracture and other contributing variables. Since all contributing factors, except the method of wound irrigation, were same in both cohorts, the author has derived a statistical conclusion that the antibiotic irrigation is the causative factor for poor wound healing. We believe this statistical conclusion is not clinically valid. Further the author has neither conducted a multivariate analysis, nor tried to find out the correlation (either pearson or chi square), between poor wound healing and other contributing factors. Hence, we would ask the author to provide these additional details on variables like age, Gustilo- Anderson grade, location, mean time from injury to irrigation, wound management and smoking.

    Sincerely yours,

    Mr. Senthil Nathan Sambandam

    Mr. Arif Gul

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