Skin Sealant Research Articles

“I will take glue with stitches”: A comparison of skin closure techniques in pancreaticoduodenectomy

Background: Surgical site complications are one of the most closely monitored and prevalent post-operative problems, occurring in as many as 15 to 28% of patients that undergo pancreaticoduodenectomy. Wound complications not only affect patient recovery and quality of life, but also negatively impact quality metrics like cost and hospital length of stay. With many closure techniques available, we sought to determine if any closure method (subcuticular stitch vs. subcuticular stitch + skin sealant vs. staples) provided a benefit of reduced post-pancreatoduodenectomy wound complications. Methods: All patients that underwent open pancreatoduodenectomy from June 2015 to June 2018 were reviewed and grouped based on wound closure (subcuticular stitch vs. subcuticular stitch + skin sealant vs. staples). We performed a retrospective review of our institution’s prospective ACS-NSQIP database and augmented it through medical record review for wound closure method and superficial surgical site complications (SSSC). These included cellulitis, seroma, abscess, fat necrosis, and other. Closure groups were compared using independent samples t-test/analysis of variance and chi-square test for continuous and categorical variables respectively. Univariable analysis and multivariable regression models were used to examine the effect of wound closure method on the various post-operative outcomes, while controlling for pre-operative and peri-operative covariables. Results: A total of 418 pancreatoduodenectomies were included on study (N=74 subcuticular stitch, N= 205 subcuticular stitch + skin sealant, N=139 stapled). Operative time did not differ between groups. There was a significant difference in the incidence of SSSC between wound closure methods. Patients with subcuticular stitch + skin sealant (9.8%) were significantly less likely to develop a SSSC compared to patients with stapled closure (20.1%) on univariable (p=0.009) and multivariable analyses (p=0.016; OR 0.37). A similar though insignificant trend was seen for patients with subcuticular stitch + skin sealant (9.8%) compared to suture alone closure (16.2%) on univariable (p=0.142) analysis. Unadjusted length of stay was significantly longer for stapled closure (11.9 days) compared to subcuticular stich + skin sealant (9.6 days) and subcuticular stitch alone (9.8 days) (p<0.05), but did not reach significance on multivariable analysis. Conclusion: Subcuticular suture with skin sealant after pancreaticoduodenectomy appears to be the preferred method for skin closure to reduce the risk of superficial surgical site complications. A change of practice and prospective study of this technique is warranted in light of this data.

Preliminary Report of the Use of Skin Sealant to Prevent Surgical Site Infection in Respiratory Surgery

Preliminary Report of the Use of Skin Sealant to Prevent Surgical Site Infection in Respiratory Surgery

Prevention of surgical site sternal infections in cardiac surgery: a two-centre prospective randomized controlled study.

Surgical site infection (SSI) of the sternum is a devastating complication in cardiac surgery. The aim of this prospective randomized controlled two-centre clinical study was to compare the use of a gentamicin-collagen sponge (Genta-Coll® resorb) and of a cyanoacrylate-based microbial skin sealant (InteguSeal®) on the SSI rate of the sternum. We analysed data from 996 consecutive patients following isolated coronary artery bypass grafting between 2012 and 2014. The patients were randomized into three groups: standard group (S-group), Genta-Coll group (G-group) and InteguSeal group (I-group). The primary study end-point was to analyse the incidence of superficial and deep sternal SSI. The secondary study end-point was to determine independent risk factors for an increased SSI rate. Of the 996 patients investigated, 332 patients were in S-group, 336 patients in G-group and 328 patients in I-group. The mean age was 67.7 ± 9.4 years, 18.6% were women and the overall SSI rate was 6.2% with 2.2% deep sternal wound infections. SSI rates were 8.3% (S-group), 5.4% (G-group) and 4.9% (I-group) (P 0.16). Multiple regression analysis demonstrated a preoperative body mass index (BMI) of >30 kg/m2 (P 0.047), re-thoracotomy for postoperative bleeding (P < 0.001) and sternum instability (P < 0.001) as independent predictors for an increased SSI rate. The application of InteguSeal® or Genta-Coll® resorb had no significant influence on the incidence of the sternal SSI rate in 996 consecutive cardiac surgery patients but demonstrated a trend towards a benefit from using these prophylactic approaches. Multiple regression analysis demonstrated a preoperative BMI of >30 kg/m2, re-thoracotomy for bleeding and sternum instability as independent predictors for an increased sternal SSI rate.

Influence of preoperative skin sealing with cyanoacrylate on microbial contamination of surgical wounds following trauma surgery: a prospective, blinded, controlled observational study

Intraoperative bacterial contamination is a risk factor for surgical site infections (SSIs). This prospective, randomized, blinded, controlled trial (Reg. No. BB08/12) investigated the effect of a cyanoacrylate-based skin sealant (InteguSeal) on intraoperative wound contamination during trauma surgery. A total of 128 patients undergoing trauma surgery were assigned randomly to an intervention (n=62) or a control group (n=66). Surgical sites were investigated at three locations: maximum incision depth (base), wound margin prior to wound closure (margin), and the surgical sutures (suture). Colony-forming units (CFU) were counted after 48h of incubation. Overall, significantly lower CFU counts were obtained for samples from the intervention group at all three sample sites compared to the control group. The difference, however, was only significant for the suture site (p=0.040). Preoperative sealing reduced microbial contamination on sutures during surgery, while the overall wound contamination remained unchanged. Hence, prevention of the clinically more relevant deep SSIs may not be expected. However, this study was not designed to detect differences in the rate of SSI. The role of the reduction in suture contamination with regard to the prevention of SSI remains to be evaluated.

Bacterial growth and wound infection following saphenous vein harvesting in cardiac surgery: a randomized controlled trial of the impact of microbial skin sealant.

The aim of the present study was to compare microbial skin sealant versus bare skin on the leg regarding intraoperative bacterial presence in the surgical wound and time to recolonization of the adjacent skin at the saphenous vein harvesting site. A second aim was to evaluate the incidence of leg wound infection 2 months after surgery. In this randomized controlled trial, 140 patients undergoing coronary artery bypass grafting (CABG) between May 2010 and October 2011 were enrolled. Bacterial samples were taken preoperatively and intraoperatively at multiple time points and locations. OF the patients, 125 (92.6 %) were followed up 2 months postoperatively regarding wound infection. Intraoperative bacterial growth did not differ between the bare skin (n = 68) and the microbial skin sealant group (n = 67) at any time point. At 2 months postoperatively, 7/61 patients (11.5 %) in the skin sealant versus 14/64 (21.9 %) in the bare skin group (p = 0.120) had been treated with antibiotics for a verified or suspected surgical site infection (SSI) at the harvest site. We found almost no intraoperative bacterial presence on the skin or in the subcutaneous tissue, irrespective of microbial skin sealant use. In contrast, we observed a relatively high incidence of late wound infection, indicating that wound contamination occurred postoperatively. Further research is necessary to determine whether the use of microbial skin sealant reduces the incidence of leg wound infection at the saphenous vein harvest site.

Cyanoacrylate Skin Microsealant for Preventing Surgical Site Infection after Vascular Surgery: A Discontinued Randomized Clinical Trial

Surgical site infections (SSI) after vascular surgery are related to substantial morbidity. Restriction of bacterial access to the site of surgery with a cyanoacrylate sealant is a new concept. We performed a randomized clinical trial to assess the effect of the sealing of skin with a cyanoacrylate preparation at the site of surgery on the incidence of SSI after arterial reconstruction. Patients scheduled for vascular reconstruction in or distal to the groin were randomized into a treatment and a control group. Standard measures for preventing contamination of the surgical field were taken in the control group, whereas cyanoacrylate was used as a skin sealant at the surgical site in the patients in the treatment group. We hypothesized that the incidence of SSI with the use of cyanoacrylate would be two-thirds (67%) lower than that with standard preparation of the surgical site, and performed an interim analysis of 50 patients to assess this. Risk factors among the 50 patients in the study included smoking (28%), hypertension (77%), diabetes mellitus (36%), and hypercholesterolemia (74%). Indications for surgery were invalidating claudication (Fontaine IIb), pain at rest, or tissue necrosis. The overall incidence of SSI was 3/47 (6%), without differences between groups; 9% SSIs in the control group versus 4% SSIs in the intervention group. We could not confirm a reduction in the incidence of SSI after inguinal vascular surgery with the use of a cyanoacrylate skin sealant as compared with conventional means for preparing the surgical site.

Impact of antimicrobial skin sealants on surgical site infections.

Surgical site infections (SSIs) after cardiac surgery remains a substantial cause of morbidity and mortality, with increasing costs due to expensive treatment and prolonged hospitalization. Because co-morbidity and bacterial resistance against appropriate antibiotic therapy increases with patient age, new prophylactic innovative strategies are needed. This article provides an overview of the current literature on the impact of microbial skin sealant to prevent SSIs. A comprehensive review of the literature reporting on microbial skin sealing to prevent surgical site infections was performed. Experimental studies showed that cyanoacrylate microbial sealant decreased skin flora contamination. Additional studies showed that cyanoacrylate not only immobilizes bacteria but also actively prohibits bacterial growth. Randomized clinical studies showed significant quantitative reduction of skin microbes at the surgical site. This results in a decrease of SSIs, which in some studies was statistically significant. Several studies on "real world" patients also showed statistically significant reduction of SSIs. Cyanoacrylate skin sealant can prohibit endogenous bacteria migration and actively reduce bacterial growth, which makes it an attractive option to reduce SSIs.

Test Taking

Test Taking

Effectiveness of N-Butyl Cyanoacrylate-Based Microbial Skin Sealant on the Prevention of Surgical Site Infections

Surgical site infections (SSIs) are a serious concern in health care, and wound contamination by endogenous skin flora is a major factor in the development of SSIs. Despite preventive tactics in pre-operative skin care, antibiotic prophylaxis, surgical technique, and post-operative incision care, complete sterilization of the skin is not possible. Recently developed microbial skin sealant forms a continuous but breathable barrier that prevents migration of endogenous skin flora into the incision. The skin sealant closes dermal microabrasions, preventing re-colonization of potential pathogens at the incision. The purpose of this study was to determine the effect of an N-butyl cyanoacrylate-based microbial skin sealant in reducing the occurrence of SSIs in an experimental rodent model. This was a randomized, controlled animal trial. Forty-eight Wistar albino rats were divided into six groups of eight rats each. Three groups received application of sealant against specific bacteria, and three matched control groups received only the bacteria without the sealant. Group one underwent pre-operative hair removal, followed by application of skin sealant, then abdominal incision and closure. Group two (control) simply underwent hair removal, followed by incision and closure, with no skin sealant applied. Group three received an application of cage swabs (containing a mixture of urine, stool and sawdust from the animals' cages) before application of skin sealant, and group four (control) received cage swabs without subsequent skin sealant. Group five received methicillin-resistant Staphylococcus aureus (MRSA) followed by skin sealant, and group six (control) received MRSA without skin sealant. Seven days after surgery, the animals were sacrificed. Samples were taken from the abdomen of each rat and placed in culture medium. Proliferation of the following bacteria were observed: Coagulase-negative staphylococci (CoNS), gram-positive bacilli (GPB), Pseudomonas aeruginosa, and MRSA. There was a statistically significant difference between the median number of GPB in the group that received cage swabs+sealant and the group that received cage swabs without sealant (median, GPB count 29,430 colony-forming units [CFU]/g vs 359,100 colony-forming units [CFU]/g; p<0.05). The study results showed that microbial skin sealant was not as effective in preventing CoNS or MRSA contamination as it was in preventing GPB contamination. Use of a microbial skin sealant before surgery can lower the rate of SSIs by reducing the migration of some specific bacterial agents. Additional data are needed to validate its use in clinical practice.

The Impact of a Microbial Sealant to Reduce Surgical Site Infections in High Risk Cardiac Surgery Patients

Introduction: Post-sternotomy infection is a serious cause for morbidity and mortality after cardiac surgery. The goal of this study was to evaluate the impact of a microbial sealant on post-sternotomy infections in high risk patients undergoing cardiac surgery. Methods: Between January 2006 and July 2008 a total of 291 consecutive patients underwent cardiac surgery with a Fowler score of at least 10, which indicates high risk patients to develop surgical site infection (SSI). Patients were divided into a control group (n=132) receiving standard institutional preoperative care and a microbial sealant group (n=159) received additionally a microbial skin sealant. Pre- and peri-operative characteristics were examined for both groups. The clinical end-point of this study was freedom of post-sternotomy infection. Results: Follow up was 100% completed. The preoperative risk score of the control and the microbial sealant group were similar, respectively 15.5 ± 4.0 and 15.2 ± 3.8 (p=0.513). Comparing pre- and peri-operative characteristics of both groups, significant higher rates of carotid artery disease (p=0.022) and diabetics (p=0.046) were found in the microbial sealant group. All other pre- and peri-operative characteristics were similar for both groups. The clinical end-point however, showed a significant decrease of SSI in the microbial sealant group 2.5% (n=4) versus the control group 7.6% (n=10), (p=0.045). Conclusions: This study showed that the additional use of a microbial sealant to standard institutional preoperative preparation reduces statistically significant the risk for surgical site infection in high risk patients undergoing cardiac surgery.

Minimally Invasive Posterior Hamstring Harvest

Autogenous hamstring harvesting for knee ligament reconstruction is a well-established standard. Minimally invasive posterior hamstring harvest is a simple, efficient, reproducible technique for harvest of the semitendinosus or gracilis tendon or both medial hamstring tendons. A 2- to 3-cm longitudinal incision from the popliteal crease proximally, in line with the semitendinosus tendon, is sufficient. The deep fascia is bluntly penetrated, and the tendon or tendons are identified. Adhesions are dissected. Then, an open tendon stripper is used to release the tendon or tendons proximally; a closed, sharp tendon stripper is used to release the tendon or tendons from the pes. Layered, absorbable skin closure is performed, and the skin is covered with a skin sealant, bolster dressing, and plastic adhesive bandage for 2 weeks.

Surgical site infections and their prevention

Recent studies have assessed interventions and bundles of interventions to prevent surgical site infections (SSIs). We reviewed numerous studies to identify those with the strongest evidence supporting interventions for preventing SSIs. Bundles that included more than one intervention to decrease the risk of Staphylococcus aureus wound contamination, such as chlorhexidine bathing and nasal application of mupirocin, had the strongest supporting evidence. However, bundles should be tested to ensure that their components are not antagonistic. Vancomycin prophylaxis and extended antimicrobial prophylaxis should not be used routinely, but should be reserved for high-risk populations such as patients who carry methicillin-resistant S. aureus (MRSA). Novel interventions to prevent SSIs (e.g., topical or oral antimicrobial agents, skin sealant, and antimicrobial sutures) need further evaluation before surgeons implement them routinely. There is some evidence that bundled interventions can reduce SSIs. However, more research should be done evaluating the effectiveness of these interventions. Future studies of bundles should use robust methodologies, such as randomized controlled trials, cluster randomized trials, or quasi-experimental studies analyzed by time series analysis.

Skin sealant InteguSeal® has no impact on prevention of postoperative mediastinitis after cardiac surgery

Surgical site infections (SSIs) after median sternotomy represent a serious complication and a high potential risk for adverse clinical outcome after cardiac surgery. The antimicrobial skin sealant InteguSeal® was introduced as a novel tool in preventing development of SSI. This single-centre investigation used two prospective registries to evaluate the prophylactic effect of a cyanoacrylate-based antimicrobial skin sealant (InteguSeal®) on the incidence of postoperative mediastinitis or any other form of chest skin incision SSI after elective cardiac surgery. Between October 2010 and April 2011 a total of 998 patients underwent elective cardiac surgical procedures with median sternotomy in our centre. In 496 patients InteguSeal® was included in standard preoperative preparation procedures before chest skin incision (group 1). In 502 patients standard preoperative skin preparation procedures were used without InteguSeal® (group 2). Freedom from mediastinitis and from any other form of SSI within 30 postoperative days were the primary and secondary endpoints, respectively. A total of 983 patients were eligible for inclusion in per-protocol analysis (488 vs 495 patients). The incidence of postoperative mediastinitis was 2.3% in group 1 vs 3.2% in group 2 (not significant). The incidence of any form of SSI was 10.9% in group 1 vs 11.5% in group 2 (not significant). Perioperative patient characteristics, complexity of surgical procedures performed and length of hospitalization were similar in both groups. The use of InteguSeal® has no influence on the incidence of postoperative SSI and mediastinitis after cardiac surgery with median sternotomy.

Skin sealant InteguSeal® has no impact on prevention of postoperative mediastinitis after cardiac surgery

Objective: Surgical Site Infections (SSI) after median sternotomy represent a serious complication and a high potential risk for adverse clinical outcome after cardiac surgery. This single-center investigation uses two prospective registries to evaluate the prophylactic effect of a cyanoacrylate-based anti-microbial skin sealant (InteguSeal®) on the incidence of postoperative mediastinitis or any other form of chest skin incision SSI after elective cardiac surgery.

Use of an Antimicrobial Skin Sealant Reduces Surgical Site Infection in Patients Undergoing Routine Cardiac Surgery

With high morbidity and potentially devastating consequences, surgical site infections (SSIs) after cardiac surgery add substantially to the healthcare burden. Inhibiting migration of skin microbes is likely to reduce contamination of the surgical incision by endogenous potential pathogens. We studied the effect of treatment with a cyanoacrylate-based antimicrobial skin sealant (INTEGUSEAL®) on the SSI rate in cardiac surgery patients. In a consecutive series of 910 prospective patients undergoing routine cardiac surgery, standard pre-operative preparation was performed on 721 patients of whom 189 also received antimicrobial skin sealant. A further 189 consecutive patients who received only standard pre-operative care were studied retrospectively. The primary study endpoint was occurrence of superficial or deep SSI according to the definitions of the U.S. Centers for Disease Control and Prevention. The mean (standard deviation) SSI risk score based on combined pre-operative and intra-operative factors according to the Society of Thoracic Surgeons risk scoring system was significantly higher for the skin sealant group (9.1±1.0) than for the prospective (7.1±3.2; p<0.001) and retrospective (8.7±0.8; p<0.001) control groups. Surgical site infections occurred in two patients (1.1%) in the sealant group, 33 patients (4.6%) in the prospective control group (p<0.025), and nine patients (4.8%) in the retrospective control group (p<0.032). When added to existing pre-operative measures to reduce bacterial contamination of surgical incisions that are employed routinely at this cardiovascular surgery unit, use of antimicrobial skin sealant decreased the incidence of SSI in cardiac surgery patients.

Evaluation of a Cyanoacrylate Dressing to Manage Peristomal Skin Alterations Under Ostomy Skin Barrier Wafers

Peristomal skin alterations under ostomy barrier wafers are a commonly reported problem. While a number of interventions to manage this issue have been reported, the use of a topically applied cyanoacrylate has received little attention. This case series describes the use of a topical cyanoacrylate for the management of peristomal skin alterations in persons living with an ostomy. Using a convenience sample, the topical cyanoacrylate dressing was applied to 11 patients with peristomal skin disruption under ostomy wafers in acute care and outpatient settings. The causes of barrier function interruption were also addressed to enhance outcomes. Patients were assessed for wound discomfort using a Likert Scale, time to healing, and number of appliance changes. Patient satisfaction was also examined. Average reported discomfort levels were 9.5 out of 10 at the initial peristomal irritation assessment visit decreased to 3.5 at the first wafer change and were absent by the second wafer change. Wafers had increasing wear time between changes in both settings with acute care patients responding faster. Epidermal resurfacing occurred within 10.2 days in outpatients and within 7 days in acute care patients. Because of the skin sealant action of this dressing, immediate adherence of the wafer was reported at all pouch changes.

A Randomized Trial of a Skin Sealant to Reduce the Risk of Incision Contamination in Cardiac Surgery

Immobilizing skin microbes is a rational approach to reducing contamination of surgical sites by endogenous microorganisms. This randomized, controlled, parallel-group, multicenter, open-label clinical trial (ClinicalTrials.gov NCT00467857) enrolled 300 adults scheduled for elective coronary artery bypass graft surgery. Patients received iodine-based skin preparations followed by a cyanoacrylate-based skin sealant or skin preparations alone. Microbiological samples collected from sternal and graft incision sites immediately before any skin preparation, at the wound border after skin incision, and at the incision after fascial closure were evaluated quantitatively. In evaluable patients, mean microbial counts in collected samples increased at the sternal site after fascial closure compared with after skin incision by 0.37 log10 colony-forming units (CFU)/mL in the skin sealant group (n=120) and by 0.57 log10 CFU/mL in the control group (n=132) (p=0.047, Wilcoxon rank sum test). At the graft site, mean microbial counts increased by 0.09 (n=119) and 0.27 (n=127) log10 CFU/mL, respectively (p=0.037). There was a 35.3% relative risk reduction in surgical site infection (SSI) occurring in the skin sealant group (9 of 146 patients, 6.2%) versus the control group (14 of 147 patients, 9.5%). In obese patients (body mass index [BMI]>30.0 to ≤37.0 kg/m2), the relative risk reduction for SSI associated with skin sealant was 83.3%. Pretreatment with skin sealant protects against contamination of the surgical incision by migration of skin microbes. Further data are needed to confirm the impact of this technology on SSI rates in clinical practice.

A retrospective non-randomized study on the impact of INTEGUSEAL, a preoperative microbial skin sealant, on the rate of surgical site infections after cardiac surgery

Surgical site infection (SSI) remains a serious potential complication after cardiac surgery. This study evaluated the impact of a cyanoacrylate microbial skin sealant (INTEGUSEAL) on the rate of SSI in cardiac surgery patients. Between January 2006 and July 2008, 580 patients underwent cardiac surgery by a single surgeon (PMD). Standard preoperative skin preparation was performed in 280 patients (control group), and 300 patients (microbial skin sealant group) received microbial skin sealant in addition to standard preoperative preparation. Patient characteristics and preoperative and combined pre/intraoperative risk scores were evaluated. The primary study endpoint was freedom from SSI within 30 days. Both groups were established in a 15-month period. Carotid artery disease, diabetes mellitus, congestive heart failure, previous cardiac surgery, and bilateral internal mammary artery use were significantly more common in the skin sealant group. Preoperative risk scores for the development of SSI in the two groups were similar. In the skin sealant group, the combined operative risk score for SSI was significantly higher (9.8±4.0 vs. 8.7±3.7; p<0.001) nevertheless the incidence of SSI was significantly lower (2.3% vs. 6.8%; p=0.011) than in the control group. Changing a surgeon's standard preoperative practice by including a microbial skin sealant pretreatment significantly reduced the rate of SSI.

Reduction of Surgical Site Infection Using a Microbial Sealant: A Randomised Controlled Trial

Reduction of Surgical Site Infection Using a Microbial Sealant: A Randomised Controlled Trial

Reduction of surgical site infection using a microbial sealant: A randomized trial

Surgical site infection is a major cause of mortality and morbidity. We have explored the use of a microbial sealant applied before the surgical incision to reduce surgical site infection. We conducted a prospective, randomized, controlled clinical trial to determine the efficacy of a cyanoacrylate sealant in patients undergoing coronary artery bypass grafting. Both left and right long saphenous veins were harvested in individual patients below the knee if 3 or more lengths of vein were required. The sealant (Kimberly-Clark InteguSeal, Roswell, Ga) was applied to 1 leg chosen randomly, and the other leg was prepared in a conventional fashion. Microbiological swabs from the leg wounds were taken at 5 days, and wounds were assessed according to the Southampton score at 30 days by 2 blinded observers. The baseline characteristics of the treated and untreated legs were similar because the procedure was conducted on each individual patient. The study was terminated at 47 patients after review. Patients in whom the sealant was used had 1 (2.1%) wound infection, and there were 12 (25.5%) wound infections in the conventionally prepared leg (P=.001). There were 13 positive cultures from the treated leg and 22 positive cultures from the untreated site. The microbial skin sealant applied immediately before the incision significantly reduced the rate of surgical site infection. There was no sensitivity or adverse reaction after application. The treatment was easily integrated with existing routine preoperative procedures. Microbial sealant may thus be a useful addition to a multimodal approach to minimize surgical site infection.