Wound Closure Device Research Articles

Tough Adhesive Puncture Sealing Sutures with Swelling Triggered Bioadhesion for Enhanced Wound Closure

AbstractSurgical sutures are gold‐standard wound closure devices. However, they are unable to form a tight seal with surrounding tissues, raising the risks of body fluid leakage and surgical site infection. Additionally, the use of sutures can result in cracking at suture roots, damage and micro‐trauma to soft tissues due to the slicing and compression of suture fibers after their placement. Bioadhesives capable of mimicking natural biological interfaces are appealing alternatives, but they cannot achieve the same level of strength as conventional surgical sutures. Here, a tough adhesive puncture sealing (TAPS) suture, featuring swelling‐triggered bioadhesion to mend the gap between the suture and the surrounding tissues with a soft yet tough adhesive interface is reported. This unique design principle of TAPS sutures is applicable to diverse soft tissues of various defect sizes and can be controlled by modulating the hydrogel swelling kinetics. The advantages of the TAPS sutures for meniscal tear repair and intestine tissue sealing ex vivo, corroborates their favorable applications in managing mechanically active musculoskeletal and gastrointestinal tissues are demonstrated. The design and performance of the TAPS sutures offer extensive possibilities for redesigning surgical tools and developing next‐generation medical devices for wound management and tissue repair.

Superiority of a Silk Surgical Site Wound Closure Device Over Synthetic Dressings

Background: Silk fibroin is an emerging biomaterial with enhanced properties of cellular regeneration, growth and proliferation. The use of a silk fibroin wound dressing has the potential to decrease the incidence of wound healing complications and to improve patient outcomes compared to synthetic dressing alternatives. Methods: A prospective, randomized, single-blinded clinical trial was conducted on 50 patients who were dressed with a silk fibroin dressing on one side of their body and on the contralateral side with 3M Steri-Strips® after undergoing abdominoplasty, reduction mammaplasty, or brachioplasty procedures. Data was collected over 5 postoperative visits using photographs and an investigator administered questionnaire to monitor erythema, skin irritation, skin discomfort, the need for pharmaceutical intervention, wound dehiscence and mechanical skin injury. A comprehensive 75 patient statistical analysis was conducted combining the results with a previously published study comparing Dermabond® Prineo® to the silk dressing. Results: 20.8% (10/48) of patients were assessed by surgeons as having skin erythema (7-10) on the Steri-Strip® control side and 0% (0/48) on the silk dressing side (p=0.002). The frequency of breast triple point separation in 43 cases was 30.2% (13/43) on the Steri-Strip® side and 9.3% (4/43) on the silk side (p=0.012). 75% (36/48) of patients had partial or total detachment of Steri-Strips® while 0% (0/48) had total detachment of the silk dressing and 18.8% (9/48) had partial detachment of the silk dressing within the first two weeks (p<0.001). Conclusion: A silk fibroin wound dressing significantly reduces the incidence of wound healing complications throughout the postoperative period. Clinical Relevance Statement: The adoption of a silk fibroin wound dressing into clinical practice has the potential to improve patient outcomes, decrease medical adhesive related skin injuries and reduce the rate of wound healing complications.

Endoscopic closure of a refractory urethroanal fistula using an innovative wound closure device.

Endoscopic closure of a refractory urethroanal fistula using an innovative wound closure device.

Endoscopic closure of a refractory urethroanal fistula using an innovative wound closure device.

Endoscopic closure of a refractory urethroanal fistula using an innovative wound closure device.

Closure of Long Surgical Incisions with Hemostatic Tissue Adhesive in a Porcine Skin Model.

Skin adhesives offer many advantages over traditional wound-closure devices. Recently, the current research group reported on tissue adhesives composed of natural polymers (gelatin and alginate), which are biocompatible with mechanical properties suitable for tissue adhesion. The objective of the present study was to conduct clinical and histologic assessment of this hemostatic bioadhesive in the healing of long skin incisions (≥4 cm) in comparison with traditional and commercially available methods. Researchers created 24 long incisions on the ventral side of two domestic pigs to compare four different treatment modalities: two topical bioadhesives based on gelatin and alginate combined with the hemostatic agent kaolin, nylon sutures, and commercial tissue adhesive N-butyl-2-cyanoacrylate. The bioadhesive compounds were spread on the incision surface and then mixed either manually or with a double-headed syringe. After 14 days, clinical and histologic measurements were performed to evaluate the healing phase of the wounds. The bioadhesive formulation that contained a relatively low crosslinker concentration demonstrated superior results to the formulation that contained a standard crosslinker concentration. However, no significant statistical differences were observed compared with the control incisions (sutures and commercial adhesive N-butyl-2-cyanoacrylate). This was verified by immunohistochemical analysis for epithelial integrity and scar formation as well as by clinical assessment. This newly developed bioadhesive demonstrated suitable properties for the closure of long incisions in a porcine skin model.

Tension Reduction With Force Modulating Tissue Bridges Reduces Wounds in Breast Surgery.

Tension on healing wounds increases the risk of dehiscence and poor or pathologic scar formation. Force modulating tissue bridges (FMTBs) represent a new class of wound closure and support devices designed to offload tension on healing wounds to improve wound healing and scar outcomes. The study was undertaken to assess the efficacy of FMTBs to reduce the risk of wound healing complications in elective breast surgery. One hundred twenty-two consecutive patients undergoing bilateral aesthetic breast surgery underwent intraoperative placement of FMTBs on the vertical limb closure site. A matched case-control cohort of 121 consecutive patients was established for comparison. Wounds were considered significant if larger than 3 mm in diameter. The primary outcome of breast wounds >3 mm was reported with a relative risk, and all outcomes were framed with number needed to treat. The control and intervention cohorts had similar demographics, comorbidities, type of operation, and incision pattern utilized. Within the FMTB group, 96.7% (n = 118) patients completed treatment per protocol. Significant wounds occurred in 1.7% (n = 2) of patients in the tissue bridge vs 15.2% (n = 19) in controls on a per patient/per protocol basis (89% reduction, P < .001). Statistically significant improvements were maintained on sensitivity analyses with intention to treat, even when minor wounds were included. There were no complications noted related to FMTBs. FMTBs are safe and highly effective at reducing the risk of wound formation in elective breast surgery. Results are consistent with sensitivity analyses based on clinical and methodological factors. Further research will assess long-term scar outcomes.

Evaluation of microMend wound closure device in repairing skin lacerations

BackgroundmicroMend, a novel microstaple skin closure device, may be able to close simple lacerations. This study aimed to evaluate the feasibility and acceptability of using microMend to close these wounds...

A Review of Barbed Sutures-Evolution, Applications and Clinical Significance.

Surgical ligatures are a critical component of any surgical procedure since they are the device that provides immediate post-surgical tissue apposition. There have been several studies to improve the design and use of these wound closure devices for different surgical procedures. Yet, there is no standardized technique or device that can be used for any specific application. Over the last two decades, there has been an increased focus on the innovative surgical sutures known as knotless or barbed sutures, along with studies focusing on their advantages and disadvantages in clinical environments. Barbed sutures were invented to reduce the localized stress on the approximated tissues as well as facilitating the surgical technique and improving the clinical outcome for the patient. This review article discusses how barbed sutures evolved from the first patent published in 1964 and how these barbed sutures influence the surgical outcomes in different procedures ranging from cosmetic surgery to orthopedic surgery performed on both human patients and animals.

Mussel Foot Protein Inspired Tape-Type Adhesive with Water-Responsive, High Conformal, Tough, and On-Demand Detachable Adhesion to Wet Tissue.

Wet adhesion is highly demanded in noninvasive wound closure, tissue repair, and biomedical devices, but it is still a big challenge for developing biosafe and tough wet bioadhesives due to low or even nonadhesion in the wet state for conventional adhesives. Inspired by the wet-adhesion-contributing factors of mussel foot proteins, a water-responsive dry robust tissue adhesive PAGU tape is made with thickness of <0.5mm through fast UV-initiated copolymerization of acrylic acid (AA), gelatin (Gel), and hexadecenyl-1,2-catechol (UH). The tape shows strong cohesive mechanical properties and strong interfacial adhesion bonds. Upon application onto wet tissue, the adhesive tape can conform to the tissue, quickly dry tissue surface through absorbing surface/interfacial water and then allows formation of interfacial bonding with a high interfacial toughness of ≈818Jm-2 . Furthermore, it can be readily detached by treating with aq. urea solution. A highly efficient avenue is provided here for producing conformable, tough, and easy detachable wet bioadhesive tapes.

Influence of ECAP process on mechanical, corrosion and bacterial properties of Zn-2Ag alloy for wound closure devices

Actual polymeric wound closure devices are not optimal for load-bearing applications due to the low mechanical properties and the risk of inflammation and bacterial infection mainly produced by multifilament and braided configurations. Biodegradable metallic Zn alloys are promising materials candidates; however, mechanical performance, corrosion behaviour, and biological response should be controlled in order to inhibit the risk of inflammation and bacterial infection. To this end, a Zn-2Ag (2 wt% Ag) alloy was processed by ECAP to evaluate the concurrent combined effect of grain refinement and Ag alloying on biodegradation and antibacterial activity. Two ECAP cycles were successfully applied to a Zn-2Ag alloy obtaining a homogeneous ultra-fine-grained structure in which nanoindentation maps suggested isotropic mechanical properties. Lower UTS and YS with higher elongation was reported after ECAP with similar corrosion rates as before processing. ECAP processed samples showed a homogeneous Ag+ release below the minimum inhibitory concentration for S. Aureus and no antibacterial effect was observed by diffusion. As expected, the presence of Ag in Zn-Ag alloys reduced bacterial attachment. Nevertheless, ECAP processed Zn-2Ag provided an excellent antibacterial activity after 3 h probably caused by the uniformly degraded and thus, non– stable, surface observed after bacterial adhesion.

A Prospective, Randomized, Controlled Comparison of Adhesive Wound Closure Devices in an Orthopaedic Patient.

Introduction:The objective of this study was to compare Zip and Clozex with a typical closure using a running 3-0 Prolene suture.Methods:A prospective, randomized, controlled trial was conducted in patients aged 18 years and older undergoing elective orthopaedic surgical procedures between 2019 and 2021. Patients were randomized to undergo skin closure using a running 3-0 Prolene suture, Zip, or Clozex. The length and location of incision, time to close, surgeon satisfaction, and complications were recorded. The Stony Brook Scar Evaluation Scale (SBSES) was used to assess cosmesis at 2 weeks and 3 months postoperatively. Patient satisfaction and adverse events were also recorded.Results:Thirty-two patients were included in the analysis. Suture closure time was longer than Zip (266 vs 123 seconds; P = 0.02) and Clozex (266 vs 91 seconds; P = 0.005). SBSES scores were greater for Clozex at 2 weeks compared with suture (4.09 vs 2.8; P = 0.005). At 3 months, Clozex maintained greater scores compared with suture (3.82 vs 2.85; P = 0.023) and Zip (3.82 vs 3.0; P = 0.046).No differences were observed in patient satisfaction at any time points.Discussion:Although patient satisfaction was similar across groups, wound closure times, SBSES scores, and total cost favor Clozex compared with Prolene suture or Zip.ClinicalTrials.gov Registration Number:NCT05251064

Blending with transition metals improves bioresorbable zinc as better medical implants.

Zinc (Zn) is a new class of bioresorbable metal that has potential for cardiovascular stent material, orthopedic implants, wound closure devices, etc. However, pure Zn is not ideal for these applications due to its low mechanical strength and localized degradation behavior. Alloying is the most common/effective way to overcome this limitation. Still, the choice of alloying element is crucial to ensure the resulting alloy possesses sufficient mechanical strength, suitable degradation rate, and acceptable biocompatibility. Hereby, we proposed to blend selective transition metals (i.e., vanadium-V, chromium-Cr, and zirconium-Zr) to improve Zn's properties. These selected transition metals have similar properties to Zn and thus are beneficial for the metallurgy process and mechanical property. Furthermore, the biosafety of these elements is of less concern as they all have been used as regulatory approved medical implants or a component of an implant such as Ti6Al4V, CoCr, or Zr-based dental implants. Our study showed the first evidence that blending with transition metals V, Cr, or Zr can improve Zn's properties as bioresorbable medical implants. In addition, three in vivo implantation models were explored in rats: subcutaneous, aorta, and femoral implantations, to target the potential clinical applications of bioresorbable Zn implants.

Influence of Ecap Process on Mechanical, Corrosion and Bacterial Properties of Zn-2ag Alloy for Wound Closure Devices

Influence of Ecap Process on Mechanical, Corrosion and Bacterial Properties of Zn-2ag Alloy for Wound Closure Devices

ITClamp-Mediated Wound Closure Speeds Control of Arterial Hemorrhage With or Without Additional Hemostatic Agents.

Exsanguination is the leading cause of preventable posttraumatic death, especially in the prehospital arena. Traditional hemorrhage control methods involve packing the wound with hemostatic agents, providing manual pressure, and then applying a pressure dressing to stabilize the treatment. This is a lengthy process that frequently destabilizes upon patient transport. Conversely, the iTClamp, a compact wound closure device, is designed to rapidly seal wound edges mechanically, expediting clot formation at the site of injury. To determine the efficacy of the iTClamp with and without wound packing in the control of a lethal junction hemorrhage. Given the limited available information regarding the efficacy of the iTClamp in conjunction with traditional hemostatic agents, this study used a swine model of severe junctional hemorrhage. The goal was to compare a multiagent strategy using the iTClamp in conjunction with XSTAT to the traditional method of Combat Gauze packing with pressure dressing application. Readouts include application time, blood loss, and rebleed occurrence. Mean application times of the iTClamp treatment alone or in conjunction with other hemostatic agents were at least 75% faster than the application time of Combat Gauze with pressure dressing. Percent blood loss was not significantly different between groups but trended the highest for Combat Gauze treated swine, followed by iTClamp plus XSTAT, iTClamp alone and finally iTClamp plus Combat Gauze. The results from this study demonstrate that the iTClamp can be effectively utilized in conjunction with hemostatic packing to control junctional hemorrhages.

A Single-Center Randomized Prospective Study Investigating the Efficacy of Various Wound Closure Devices in Reducing Postoperative Wound Complications

BackgroundSutures and staples are the mainstay wound closure techniques in total joint arthroplasty. Newer techniques such as zipper devices and novel skin adhesives have emerged because of their potential to decrease operative time and possibly minimize complications. The aim of this study is to compare these newer techniques against conventional sutures with respect to wound complications, closure time, and costs. MethodsA single-center randomized control trial was conducted on 160 patients (52 zipper, 55 suture, 53 mesh) who underwent primary total hip or knee arthroplasty between February 2017 and May 2018. Patients were divided into 3 closure groups: zipper device, monofilament suture plus adhesive, and monofilament plus polyester mesh with adhesive. The primary endpoint was closure time (superficial skin layer). Secondarily we collected perioperative complication rates, including infection, persistent (14-day) wound drainage, 90-day readmission, and emergency room visit rates as well as compared material costs. ResultsThere were no differences in baseline characteristics between groups for age, body mass index, and American Society of Anesthesiologists classification. There was a trend toward decreased time to closure for the suture group. There were no significant differences between groups for our secondary endpoint, complications. ConclusionsOur study shows that the suture group trended toward shorter closure time but suggests that each of the closure methods after total joint arthroplasty has equivalent complication rates. With small differences in closure time and no significant differences in complications, the decision to use one wound closure device or technique over another should be driven by institutional costs and provider familiarity.

Prolonged Usage of an Adhesive Wound Closure Device in Postoperative Facial Scar Management: A Split-Wound Randomized Controlled Trial.

Background: Additional skin support is promising in scar management, especially for wounds under high tension. Options for effective skin support are limited. This study aimed to determine whether prolonged use of an adhesive wound closure (AWC) device prevents scar spread and improves final appearance. Patients and Methods: This is a split-wound randomized evaluator-blinded study of 14 patients with facial wounds under high tension. After surgical closure, one half of each wound was randomly allocated to receive either standard care or additional 3-month treatment with an AWC device. Scar width, scar scale, and side effects were evaluated 12 months after surgery. Results: A significant difference was observed in scar width between the treated and nontreated sites at 12-month, with a mean difference of 1.024 (95% confidence interval, 0.347-1.700) mm in favor of the treated group. Scar widths in both groups increased rapidly in the first month after surgery and gradually increased until the sixth month. Scale for vascularization and relief were significantly lower in the treated sites. No significant differences were found in complications between two groups. Conclusions and Relevance: Prolonged usage of the AWC device prevented scar spread at 12 months and improved final scar scores in vascularization and relief. Clinical Trial Registration number: ChiCTR1900027155.

The Management of Abdominal Evisceration in Tactical Combat Casualty Care: TCCC Guideline Change 20-02.

Historically, about 20% of hospitalized combat injured patients have an abdominal injury. Abdominal evisceration may be expected to complicate as many as one-third of battle-related abdominal wounds. The outcomes for casualties with eviscerating injuries may be significantly improved with appropriate prehospital management. While not as extensively studied as other forms of combat injury, abdominal evisceration management recommendations extend back to at least World War I, when it was recognized as a significant cause of morbidity and was especially associated with bayonet injury. More recently, abdominal evisceration has been noted as a frequent result of penetrating, ballistic trauma. Initial management of abdominal evisceration for prehospital providers consists of assessing for and controlling associated hemorrhage, assessing for bowel content leakage, covering the eviscerated abdominal contents with a moist, sterile barrier, and carefully reassessing the patient. Mortality in abdominal evisceration is more likely to be secondary to associated injuries than to the evisceration itself. Attempting to establish education, training, and a standard of care for nonmedical and medical first responders and to leverage current wound management technologies, the Committee on Tactical Combat Casualty Care (CoTCCC) conducted a systematic review of historical Service guidelines and recent medical studies that include abdominal evisceration. For abdominal evisceration injuries, the following principles of management apply: (1) Control any associated bleeding visible in the wound. (2) If there is no evidence of spinal cord injury, allow the patient to take the position of most comfort. (3) Rinse the eviscerated bowel with clean fluid to reduce gross contamination. (4) Cover exposed bowel with a moist, sterile dressing or a sterile water-impermeable covering. It is important to keep the wound moist; irrigate the dressing with warm water if available. (4) For reduction in wounds that do not have a substantial loss of abdominal wall, a brief attempt may be made to replace/reduce the eviscerated abdominal contents. If the external contents do not easily go back into the abdominal cavity, do not force or spend more than 60 seconds attempting to reduce contents. If reduction of eviscerated contents is successful, reapproximate the skin using available material, preferably an adhesive dressing like a chest seal (other examples include safety pins, suture, staples, wound closure devices, etc.). Do not attempt to reduce bowel that is actively bleeding or leaking enteric contents. (6) If unable to reduce, cover the eviscerated organs with water-impermeable, nonadhesive material (transparent preferred to allow ability to reassess for ongoing bleeding; examples include a bowel bag, IV bag, clear food wrap, etc.), and then secure the impermeable dressing to the patient using an adhesive dressing (e.g., Ioban, chest seal). (7) Do NOT FORCE contents back into abdomen or actively bleeding viscera. (8) Death in the abdominally eviscerated patient is typically from associated injuries, such as concomitant solid organ or vascular injury, rather than from the evisceration itself. (9) Antibiotics should be administered for any open wounds, including abdominal eviscerating injuries. Parenteral ertapenem is the preferred antibiotic for these injuries.

112 Evaluation of MicroMend Wound Closure Device in Repairing Skin Lacerations

112 Evaluation of MicroMend Wound Closure Device in Repairing Skin Lacerations

A novel zipper device versus sutures for wound closure after surgery: a systematic review and meta-analysis.

We performed an updated meta-analysis to compare the efficacy of the zipper device and sutures for wound closure after surgery. A computerised literature search was performed for published trials in PubMed, Web of Science, the Cochrane Library, and Google Scholar. Two reviewers independently scrutinised the trials, extracted data, and assessed the quality of trials. The primary outcome was surgical site infections (SSI). The secondary outcomes were wound dehiscence, total wound complications, wound closure time, and scar score. Statistical analysis was performed in the Stata 12.0. Of the 130 citations, eight trials (1207 participants) met eligibility criteria and were included. The zipper device achieved a lower SSI rate (RR: 0.63, [95% CI: 0.41-0.96, P = 0.032]), a shorter wound closure time (SMD: -8.53 [95% CI: -11.93 to -5.13, P = 0.000]) and a better scar score (SMD: 0.42 [95% CI: 0.22-0.62, P = 0.000]) than sutures. No significant difference was shown in the incidence of wound dehiscence and total wound complications. Therefore, the zipper device provides the advantages of anti-infection, time-saving, and cosmesis for wound closure.

Noninvasive Wound Closure in the Emergency Department.

Emergency department (ED) providers spend a significant amount of time treating low-acuity medical conditions, such as simple laceration repairs. Lacerations account for 5% of all ED visits in the United States (). An extended period of time by the provider is required for traditional wound repair, and there is perceived pain reported by patients (). The closure devices (Zip Closure device) are a latex-free, noninvasive alternative to staples, sutures, and glue and make wound closure an easy, fast process, allowing patients to remove the device after the wound has healed. The purpose/aim of this quality improvement project was to implement and evaluate the effectiveness of a noninvasive wound closure technique in the ED. The specific aims were to determine whether the Zip Closure device resulted in cost savings for the facility by decreasing the provider time that was needed for the laceration repair and determine whether there was an improved patient satisfaction compared with traditional wound closure methods. Following provider education regarding the use of the Zip Closure device, the device was available to providers over a 4-month period of time for use with patients in the ED. There were 63 lacerations seen in the ED during the 4 months of the quality improvement project, and an evaluation note was completed by a provider on all wounds. Six subjects were treated with the Zip Closure device, and 5 expressed satisfaction with the device. Providers stated that barriers to using the product on more wounds were that the lacerations were nonlinear, complex, high tension, and superficial or involved the finger, hand, scalp, face, or mouth; therefore, the device was inappropriate for treatment of the laceration. This was preliminary work of the noninvasive wound closure device. It is recommended that the study be repeated in a larger ED setting.