aSrinivas Sai A. Kondapalli, MD; b,cCraig N. Czyz, DO, FACS; dAndrew W. Stacey, MD; c,eKenneth V. Cahill, MD, FACS; b,c,eJill A. Foster, MD, FACS aDepartment of Ophthalmology, Loyola University Medical Center, Maywood, Illinois; bDivision of Ophthalmology, Section Oculofacial Plastic and Reconstructive Surgery, Ohio University/OhioHealth Doctor’s Hospital, Columbus, Ohio; cDepartment of Ophthalmology, Oral and Maxillofacial Surgery, Grant Medical Center, Columbus, Ohio; dDepartment of Ophthalmology, University of Michigan, Ann Arbor, Michigan; eDepartment of Ophthalmology, The Ohio State University, Columbus, Ohio
Disclosure: The authors report no relevant conflicts of interest.
Purpose: Kaolin is a mineral shown to be effective in controlling hemorrhage when combined with standard gauze and applied to wounds. This study investigates the application of kaolin to control intraoperative bleeding and promote wound healing in eyelid surgery. Methods: This prospective, randomized, double-blind study recruited patients who underwent eyelid surgery. Following skin incision, kaolin-impregnated gauze was placed in one eyelid wound bed and cotton gauze in the other, then removed. Distinct, individual areas of bleeding were recorded. Standardized photographs were obtained postoperatively on Day 1, 4, and 7. Photographs were graded for edema and ecchymosis by four blinded observers. Patients also completed a survey inquiring which side had more bruising, swelling, and pain at each return visit. Results: A total of 46 patients completed the study. The number of intraoperative bleeding sites for kaolin versus plain gauze was not significantly different (p=0.96). Photographic grading by blinded observers did not identify any statistically significant differences in postoperative edema at any time point between lids. There was a statistically significant difference for ecchymosis at postoperative Day 4 (p=0.009) and Day 7 (p=0.016). Patient surveys did not show any difference in perceived edema, ecchymosis, or pain between lids. Conclusion: Intraoperative hemostasis was not affected by the use of kaolin-impregnated gauze. The effectiveness of kaolin in wound healing showed improved ecchymosis at Days 4 and 7 when assessed by blinded observers. Patients did not notice any improvement in postoperative edema, ecchymosis, or pain. (J Clin Aesthet Dermatol. 2016;9(6):51–55.)
Upper eyelid surgery involves incisions, excision of skin, and often a portion of the orbicularis muscle. The procedural variables, including incisional modality and the patients’ hemodynamic profiles, result in unpredictable hemostasis. The eyelids have relatively small caliber vessels, but a rich plexus of vascularity. Hemostasis is a critical component of a successful eyelid surgery and postoperative safety. In the case of eyelid surgery, orbital hemorrhage with vision loss is estimated to happen 1 in 2,000 to 1 in 25,000 cases.
Hemostasis can be achieved by mechanical, thermal, and/or pharmacological means. Mechanical methods include placing direct pressure over the wound or suture ligation of distinct vessels. Mechanical methods are beneficial in obtaining hemostasis, but may prolong surgical time and induce unwanted effects. Ligation sutures introduce foreign material and may alter wound healing.
Thermal-based methods employ the use of heat to denature hemorrhaging tissues and to seal vessels. Risks of thermal modalities include patient injuries, user injuries, fire, and electromagnetic interference with other medical equipment. By causing local tissue destruction, thermal-based modalities may alter wound healing, causing a reduced functional and/or cosmetic result. Moreover, devitalized tissue may increase risk of infection.
Pharmacological agents, such as epinephrine, vitamin K, and protamine, have been used to improve hemostasis. Systemic effects of pharmacological agents may discourage their use. Without proper hemostasis, a hemorrhage and/or hematoma may develop, resulting in wound dehiscence, further surgery, or other unwanted sequalae.
Kaolin is a naturally occurring aluminum silicate mineral derived from clay. It has been used homeopathically to promote wound healing and reduce scar formation for centuries. Kaolin activates clotting factor XII (Hageman factor) when exposed to plasma, thus activating Factors XII, XI, and prekallikrein. A novel hemostatic dressing called QuickClot® Combat Gauze (Z-Medica, Wallingford, Connecticut) is a non-woven medical gauze of 50 percent polyester and 50 percent rayon impregnated with kaolin. The gauze is impregnated with the inert kaolin mineral without use of animal or human proteins; no allergic reactions have been reported.
Kaolin-impregnated gauze has been shown to be efficacious in stabilizing arterial hemorrhages in swine models. In addition, studies show kaolin-impregnated gauze to be safe and effective in controlling hemorrhage in extremity and abdominal sites.[5–8] Most recently, kaolin-impregnated gauze has been shown to achieve hemostasis in femoral artery access sites during percutaneous coronary interventions. Kaolin-impregnated gauze is the “only approved hemostatic agent for all the United States Armed Forces,” and is given to the frontline soldiers in first aid kits. Intrigued by its applications in situations requiring hemostasis at various body sites, this study was conceived to examine the application of kaolin-impregnated gauze to control intraoperative bleeding and promote wound healing in eyelid surgery. While excessive bleeding is uncommon in eyelid surgery, the rare catastrophic outcome of visual loss motivates us to search for modifiable features to improve hemostasis without compromising surgical outcomes. Further, improved immediate postoperative cosmesis is something patients routinely seek, but is difficult for surgeons to provide.
This prospective, randomized, double-blind study was conducted following Institutional Review Board approval. Written consent was obtained and the Health Insurance Portability and Accountability Act of 1996 guidelines were followed. Patients undergoing primary bilateral upper lid blepharoplasty were recruited to participate. Study exclusion criteria was age less than 18 years of age and/or previous blepharoplasty. Patients were asked to refrain from using anticoagulant medications and supplements, if medically able, 10 days prior to surgery. Three different surgeons performed the operations in an identical surgical setting using the same operative equipment and technique.
Prior to patient, surgeon, and first assistant arrival into the operating room, the scrub technician and research coordinator determined to which side—left versus right—the kaolin-impregnated gauze would be applied. Each patient received 3cc’s of local anesthetic in the preoperative area (2% lidocaine with 1:100,000 epinephrine mixed 50/50 with 0.75% Marcaine and 10 units of hyaluronidase). The local was injected via a single transcutaneous puncture into each upper lid with a 30-gauge needle. The injections were given 10 to 15 minutes prior to skin incision.
The skin incisions were performed with a #15 Bard-Parker blade. The skin and orbicularis muscle were then excised with Westcott scissors (Figure 1). A 4x4cm piece of sterilized kaolin-impregnated gauze was placed on one wound bed, and a 4x4cm piece of cotton gauze on the other. The gauze was held in place with gentle digital pressure by the first assistant for four and a half minutes (Figure 2). After the allotted time, the gauze was gently rolled off the wound. Individual areas of bleeding were counted, recorded, and addressed with electrocautery (Figure 3). The remainder of the surgery proceeded in a standard fashion. Intraoperative complications and the use of additional local anesthetic were noted if they occurred. Standard postoperative and wound care instructions were provided to all patients.
Patients returned for standardized postoperative photographs on Day 1, 4, and 7. The photographs were taken in the frontal, three-fourths, and lateral perspective. Photographs were compiled, randomized, and then graded for edema and ecchymosis by four blinded surgeons. Each side was compared to the contralateral side providing built-in control and standardization. Observers were given the grading choices of 1) right greater than left, 2) left greater than right, 3) no difference between sides, and 4) absence of findings for both sides. At each postoperative visit, patients completed a three-question survey inquiring which side, left versus right, had more bruising, swelling, and pain. The patients also had the option of choosing no difference between the sides or a lack of findings on both sides.
Statistical analysis was conducted with SPSS 20 (IBM Corporation, Somers, New York). It was determined the use of multiple comparison correction was not required for the data set prior to analysis. Nonparametric categorical data was analyzed with Fisher’s exact test. Scaled data was analyzed with an unpaired t-test. Intraclass correlation coefficient (ICC) for observer grading was not calculated due to data type. All statistical testing was two-tailed and conducted at the 0.05 alpha level. Post hoc power analysis showed all tests were powered at a minimum of 95%.
Forty-nine patients were enrolled in the study with three patients being unable to complete the entire follow-up. Patient age ranged from 51 to 91 with a mean of 65 years old (SD=8.8). There were eight males and 38 females who completed the study.
Intraoperatively, an average of 4.7 (range 0–9, SD=1.9) distinct areas of bleeding were noted in the wound beds treated with kaolin-impregnated gauze versus 4.7 (range 0–13, SD=1.8) in the wounds treated with standard gauze, as illustrated in Table 1 . Statistical analysis showed no difference between the gauze treatments (CI 1.22 to 1.14, p=0.96). No postoperative complications of infection or hemorrhage were documented. The use of additional local anesthetic was not required for hemostasis in any case.
On postoperative Days 1, 4, and 7, patients responded to survey questions about bruising, swelling, and pain. Results of the survey are shown in Table 2. There was no statistically significant difference between standard and kaolin gauze sides for any category at any time point.
The grading results of the blinded surgeon observers for edema and ecchymosis is displayed in Table 3 and Table 4 . There was no statistically significant difference between groups for either of the variables other than ecchymosis at postoperative Days 4 (p=0.009) and 7 (0.016).
The increased prevalence of the use of anticoagulant medications and dietary supplements has made intraoperative hemostasis during eyelid surgery more challenging. In 2007 alone, the number of outpatient prescriptions for warfarin was close to 31 million. This does not take into account other anticoagulants, such as aspirin, clopidogrel, or fish oil. Despite the advent of new anticoagulant medications, there have been few advances in modalities for controlling intraoperative hemorrhaging. Further, with the rise of patients seeking cosmetic surgical rejuvenation with minimal “downtime,” decreasing postoperative edema and ecchymosis is a significant issue.
The use of kaolin-impregnated gauze for improved hemostasis during eyelid surgery showed no intraoperative benefit (Table 1). It was anecdotally noted that while using kaolin gauze, intraoperative time was prolonged, due to the time required to apply the gauze and allow sufficient time for it to act. While immediate effects of the gauze could not be quantified, there did appear to be some postoperative benefit. Initial (Day 1) blinded observer graded postoperative ecchymosis was not improved by kaolin. However, on postoperative Days 4 and 7, lids for which kaolin-impregnated gauze was used intraoperatively were found to have less postoperative ecchymosis (Table 3).
The surgeon observers did not note any differences in postoperative edema between the gauze modalities (Table 4). This finding was supported by the patient self-evaluations, where no differences in edema or ecchymosis were noted (Table 2). The disparate results of surgeon graded edema and ecchymosis may not detract from the results as much as perceived. Postoperative edema and ecchymosis are related entities, rarely occurring in isolation from one another. A significant amount of ecchymosis can potentially obscure the identification of mild-to-moderate edema. Similarly, the evaluation of a three-dimensional finding (i.e., edema) using a two-dimensional photographic image can reduce the sensitivity of the results. Further, it is highly possible that the procedure under study simply does not produce significant postoperative edema absent of complication.
There are some additional considerations and limitations of this study. Initial studies utilizing kaolin-impregnated gauze for controlling hemorrhage in swine models suggested greater efficacy with repeated applications. Repeated applications of the compound may produce improved results, but ultimately lengthen operative time. In addition, previous models and studies employed kaolin-impregnated gauze for high-flow arterial and venous wounds. The incisions and resultant wounds in eyelid surgery are often superficial and lack large vessel blood flow. Without this flow, kaolin may be unable to assert its effect on the clotting cascade. Similarly, the military applications for kaolin gauze are those in which tourniquets or direct pressure is insufficient to control bleeding. Bleeding encountered during eyelid surgery rarely meets these criteria. The clinical scenarios where kaolin is helpful may not occur in eyelid surgery, limiting its usefulness for this application.
Kaolin-impregnated gauze for hemostasis in eyelid surgery showed limited benefit. There was no quantifiable change in intraoperative hemostasis. The postoperative effects on lid edema and ecchymosis were only noted in the later stages of healing by surgeons, but not patients. The lack of clear evidence of hemostasis improvement suggests that the time and cost of using kaolin-impregnated gauze should be evaluated on a patient-by-patient basis. In instances where a shortened recovery period and improved cosmetic outcome is desired, kaolin may be of benefit.
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