The Use of Hemostatic Agents in General Plastic Surgery Procedures (AQA 2023 PDF)

Original Article Research The Use of Hemostatic Agents to Decrease Bleeding Complications in General Plastic Surgery Procedures Joshua A. Bloom, MD* Zachary Erlichma...

Original Article Research The Use of Hemostatic Agents to Decrease Bleeding Complications in General Plastic Surgery Procedures Joshua A. Bloom, MD* Zachary Erlichman, BS† Background: Within plastic surgery, hematomas and seromas are frequently Sina Foroutanjazi, BS† reported complications that can negatively impact wound healing and result in sig- Zhaneta Beqiraj, MA* nificant morbidity in patients. As a result, there has been considerable interest in Michael M. Jonczyk, MD, MSCTS* hemostatic agents to complement traditional methods of hemostasis. The purpose Sarah M. Persing, MD, MPH‡ of this study was to evaluate postoperative bleeding complications and duration of Abhishek Chatterjee, MD, MBA, Jackson-Pratt (JP) drain use in general plastic surgery procedures with and without FACS§ hemostatic agents. Methods: After obtaining institutional review board approval, a retrospective chart review was performed. Patients who underwent bilateral breast reduction, pan- niculectomy, or abdominoplasty were included. Data collected included indication for surgery, type of operation, use of hemostatic agent, specifically fibrin sealant (FS, EVICEL, Ethicon, USA) or combination powder (CP, HEMOBLAST Bellows, Biom’up, France), length of follow-up, time to JP drain removal, postoperative complications, and specimen weight. This was a consecutive experience where ini- tially no hemostatic agent was used, followed by use of FS, and then CP. Results: The use of a hemostatic agent resulted in reduced time duration for JP drain use and overall fewer recorded complications in the hemostatic agent groups. Although not significant, the hemostatic agent group (FS and CP) expe- rienced fewer hematomas and seromas compared with the nonhemostatic agent group. JP drain duration was significantly less among breast reduction (3.46 versus 6.92 days, P < 0.01) for CP when compared with FS. Conclusion: The use of hemostatic agents in general plastic surgery procedures may result in decreased postoperative complications and significantly reduce time to JP drain removal. (Plast Reconstr Surg Glob Open 2021;9:e3744; doi: 10.1097/ GOX.0000000000003744; Published online 19 August 2021.) INTRODUCTION tissue envelope, creating a new potential space with raw Common postoperative complications after plastic sur- surface area.1,2 Adequate intraoperative hemostasis is one gery procedures include hematomas and seromas. These of the tenets of meticulous surgical practice; however, post- complications can negatively impact wound healing and operative hematoma and seroma formation can often be result in significant morbidity in patients. This phenom- inevitable regardless of surgical technique. For example, enon is predominantly due to undermining of the soft in breast reduction operations, seromas and hematomas occur at a rate of 1.2% and 3.7%, respectively,3 whereas in abdominoplasty/panniculectomy operations, seromas From the *Department of Surgery, Tufts Medical Center, Boston, and hematomas occur at a rate of 10%4 and 1.1%,5 respec- Mass.; †Tufts University School of Medicine, Boston, Mass.; tively. Multiple devices and products (such as FSs or glues, ‡Division of Plastic and Reconstructive Surgery, Department of gelatin-based seals, adhesives, human fibrinogen, PEG Surgery, University of Southern California, Los Angeles, Calif.; hydrogel, adhesive dressings, and negative pressure wound and §Division of Plastic and Reconstructive Surgery, Department vacuum systems) have been developed to enhance surgi- of Surgery, Tufts Medical Center, Boston, Mass. cal hemostasis and to reduce the risk of hematoma and Received for publication April 1, 2021; accepted June 14, 2021. seroma formation through the perioperative period.6–9 Copyright © 2021 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The American Society of Plastic Surgeons. This is an open-access article distributed under the terms of the Creative Disclosure: Dr. Chatterjee is a consultant for Biom’Up. All Commons Attribution-Non Commercial-No Derivatives License 4.0 the other authors have no financial interest to declare in rela- (CCBY-NC-ND), where it is permissible to download and share the tion to the content of this article. This study was partially work provided it is properly cited. The work cannot be changed in supported by an Investigator Initiated Study grant from any way or used commercially without permission from the journal. Biom’Up. DOI: 10.1097/GOX.0000000000003744 www.PRSGlobalOpen.com 1  PRS Global Open 2021 A common method for early detection of hematoma t-test. Postoperative complications were compared using formation and preventing seroma formation is via place- Fisher exact test. Statistical significance was defined as a P ment of closed-suction drains, such as Jackson Pratt (JP) value less than 0.05. or Blake drains, intraoperatively.10 The duration of time Institutional review board approval was obtained. This until drain removal depends upon the drain’s output and study was conducted in accordance with the principles can range from a few days to weeks.11,12 The volume below outlined in the Declaration of Helsinki. which the suction drains are removed is typically 30 mL per day, although it can vary by surgeon’s preference. Earlier RESULTS removal of drains can be thought to correlate with a lower The use of a hemostatic agent resulted in reduced volume of serosanguinous drainage. Using this concept, the time duration for JP drain use and overall fewer recorded time-to-removal of drains can be used as a surrogate to deter- bleeding complications when compared with the nonhe- mine the efficacy of the hemostatic technique or product. mostatic agent group (Table 1). For the nonhemostatic Given that the role of such hemostatic agents in these agent group, there was a 6.6% incidence of seroma, 1.6% plastic surgery operations has been limited, the aim of this incidence of hematoma, and 1.6% incidence of cases for study was to (1) evaluate the frequency of postoperative return to OR for breast reductions (n = 61). The CP group bleeding complications, and (2) the duration of JP drain experienced no hematomas, seromas, or return to OR for use in general plastic surgery procedures with and without breast reduction (n = 26) procedures in contrast to the FS the use of hemostatic agent. group (n = 66) with a 4.5% seroma and 1.5% hematoma rate. These were without statistical significance. JP drain METHODS duration was statistically significantly decreased among A retrospective chart review was performed from breast reduction (3.46 versus 6.92 days, P < 0.01) for CP a single surgeon’s case database from January 2015 to when compared with FS (Fig. 1). September 2020. Patients were included who underwent For abdominoplasty and panniculectomy procedures bilateral breast reduction, panniculectomy, or abdomi- in the nonhemostatic agent group, there was a 6.6% noplasty. Those on anticoagulation and not undergoing incidence of seroma, 8.2% incidence of hematoma, and these procedures were excluded from the analysis. 4.9% incidence of cases for return to OR (n = 61). The CP group experienced no hematomas, seromas, or return to Surgical Technique OR for abdominoplasty/panniculectomy (n = 14) when We used the Caprini score to assess whether there was compared with the FS group (n = 4) with one instance a need for deep vein thrombosis prophylactic anticoagu- each of hematoma, seroma, and return to OR. Again, lation. Breast reductions were performed using a Wise these were without statistical significance. In general, the pattern incision and based upon either an inferior or vast majority of patients had a low Caprini score and did superomedial pedicle depending on the degree of ptosis. not receive deep vein thrombosis chemoprophylaxis. Abdominoplasties and panniculectomies were done in the standard fashion without the use of progressive tension sutures to help eliminate deadspace. DISCUSSION Of note, before operative closure of any incision site, Similar to most surgical disciplines, plastic surgery pro- lidocaine with epinephrine was injected for postoperative cedures are not without associated complications. Seromas analgesia, and the surgeon made sure that the patient was and hematomas are a relatively common complication due not hypotensive so as to minimize the chances of miss- to increased dead space created from the mobilization of ing vessels that would potentially bleed when the patient the overlying soft tissues. Therefore, the use of hemostatic became normotensive postoperatively. No tumescent fluid agents can greatly reduce these complications. Studies look- was used. ing at hemostatic agents in these types of common plastic Data were collected including the indication for sur- surgeries are rare, and our results are among the first to gery, type of operation, use of hemostatic agent, specifi- examine these agents within general plastic surgery and to cally FS (EVICEL, Ethicon, USA) or combination powder evaluate their efficacy. The importance of decreasing com- (CP, HEEMOBLAST Bellows, Biom’up, France), length of plications cannot be understated as it not only aligns with the follow-up, duration of time to JP drain removal, postop- goals of the surgeon in doing no harm, but it also improves a erative complications [seroma, hematoma, or operating patient’s experience and satisfaction13 and decreases finan- room (OR) takeback], and specimen weight. Specimen cial cost burden to both patients and society.14,15 weight was used to standardize the amount of deadspace This study evaluated two distinct categories of hemo- among patients with differing BMI. static agents. The first of these is EVICEL, a fibrin-sealant- This was a consecutive experience where initially no based product, which consists of BAC2 (human fibrinogen) hemostatic agent was used, followed by use of FS (begin- and thrombin, and is FDA approved for surgical hemosta- ning June 2017), and then CP (beginning August 2019). sis.16 The other product is HEMOBLAST Bellows, which These changes were motivated by an observed increase in has recently gained traction as a newer intraoperative bleeding complications. hemostatic agent. It contains human-derived thrombin JP drains were removed in the clinic when drain out- that works within the coagulation cascade and activates put was less than 30 cm3 per day for 2 consecutive days. JP the conversion of fibrinogen to fibrin. Additionally, the drain output was compared between groups using Welch porcine-derived collagen and the chondroitin sulfate in 2 Bloom et al. Hemostatic Agents in Plastic Surgery Table 1. Rates of Postoperative Complications, Time to JP Drain Removal, and Specimen Weight for General Plastic Surgery Procedures Using No Hemostatic Agent versus EVICEL (FS) and HEMOBLAST Bellows (CP) No Hemostatic Agent HEMOBLAST Bellows (CP) Breast Abdominoplasty/ Breast Abdominoplasty/ Reduction Panniculectomy Reduction Panniculectomy N 61 61 26 14 Avg F/u (wk) 11.3 13.17 6.27 7.21 Avg time with JP (d) 8.67 27.89 3.46 14.1 SD 3.75 14.27 3.96 6.63 P < 0.01 P < 0.01 Average specimen weight (kg) 1.54 2.58 1.25 2.02 SD 0.96 1.68 0.54 0.98 P = 0.08 P = 0.16 Seroma (%) 4 (6.6) 4 (6.6) 0 (0) 0 (0) P = 0.31 P = 0.67 Hematoma (%) 1 (1.6) 5 (8.2) 0 (0) 0 (0) P=1 P=1 OR takeback (%) 1 (1.6) 3 (4.9) 0 (0) 0 (0) P=1 P = 0.23 EVICEL (FS) HEMOBLAST Bellows (CP) Breast Abdominoplasty/ Breast Abdominoplasty/ Reduction Panniculectomy Reduction Panniculectomy N 66 4 26 14 Avg F/u (wk) 8.95 12.75 6.27 7.21 Avg time with JP (d) 6.92 18.25 3.46 14.1 SD 3.05 13.45 3.96 6.63 P < 0.01 P = 0.25 Average specimen weight (kg) 1.58 3.28 1.25 2.02 SD 0.84 2.23 0.54 0.98 P = 0.028 P = 0.43 Seroma (%) 3 (4.5) 1 (25) 0 (0) 0 (0) P = 0.56 P = 0.22 Hematoma (%) 1 (1.5) 1 (25) 0 (0) 0 (0) P=1 P = 0.22 OR takeback (%) 0 (0) 1 (25) 0 (0) 0 (0) P=1 P = 0.22 its formulation provide cohesion to the wound, which has with the traditional hemostatic matrix.17–19 Therefore, been shown to further enhance its hemostatic effect with based upon the multiple mechanisms of HEMOBLAST a similar safety profile.16 Previous studies have shown that Bellows, it may be preferable to EVICEL for use in surgical the combined powder used in the HEMOBLAST Bellows hemostasis. has a superior role in immediate hemostasis in cardio- Utilizing results from hundreds of patients, the thoracic, abdominal, and orthopedic surgery compared use of hemostatic agents (CP and FS) had a statistically Fig. 1. Duration of time to JP drain removal. *Statistically significant when compared with no hemo- static agent. †Statistically significant when compared with EVICEL (FS). 3  PRS Global Open 2021 significant reduction in time to JP drain removal and detailed and standardized data set incorporating many overall fewer bleeding complications, including seroma, institutions to analyze outcomes more precisely and hematoma, and OR takeback. This effect on time before accurately. JP drain removal was more pronounced in the CP group. It should be noted that the size of tissue excised was similar CONCLUSION between groups, increasing the robustness of the results. The use of hemostatic agents in general plastic surgery Therefore, the use of the agents may potentially improve procedures significantly shorten time to JP drain removal cosmetic outcomes and patient experience due to a reduc- and may decrease postoperative complications, including tion in complications and overall time with JP drains. seroma, hematoma, and OR takeback. Earlier removal of drains decreases patient discom- fort and theoretically prevents the chances of drain infec- Joshua A. Bloom, MD tions. It is interesting to note that even with statistically 800 Washington Street decreased drain times, the hemostatic agent groups Boston, MA 02111 E-mail: [email protected] showed a decrease in overall seromas supporting a mecha- nism for decreased postoperative seroma complications other than the presence of a drain. This is thought to be ACKNOWLEDGMENT secondary to the hemostatic agent collapsing and decreas- The authors thank all who helped make this project possible. ing deadspace.20 It should be noted that the American Society of Plastic REFERENCES Surgeons guidelines recommend against the routine use 1. Jordan SW, Khavanin N, Kim JYS. Seroma in prosthetic breast of drains in standard reduction mammaplasty (Level reconstruction. Plast Reconstr Surg. 2016;137:1104–1116. 1 evidence). In our practice, drain use has begun to be 2. Seth AK, Hirsch EM, Kim JY, et al. Hematoma after mastectomy phased out in most breast reductions. This is largely with immediate reconstruction: an analysis of risk factors in 883 patients. Ann Plast Surg. 2013;71:20–23. due to the routine use of hemostatic agents leading to 3. Cunningham BL, Gear AJ, Kerrigan CL, et al. Analysis of breast decreased bleeding complications and decreased length reduction complications derived from the BRAVO study. Plast of drain times. 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