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SurgiSeal USFDA Approved Topical Skin Adhesive With Patented Octylflex Technology

Author: Dr. Nagesh Mandapaka*, Dr. Sheng Zhang#

*MBBS, MS - General Surgery at IRIS Multispeciality Hospital, Kolkata, #PhD – Chemistry VP - R&D (Adhezion Biomedical)

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Traditionally, most incision was closed by sutures but in recent times topical skin adhesive are being used frequently. Surgiseal, a topical skin adhesive offers many characteristics of a ideal wound closure device that is easy to use, rapid wound healer, painless, result in excellent cosmesis, not require device removal, and is cost-effective. Surgiseal (2-octylcyanoacrylate) provides the optimal balance between strength and flexibility with patented OctylFlex Technology. Surgiseal can replace suture that are 5-O or smaller in diameter for incision or laceration repair and is designed to save time during wound repair.The formulation leads to the scarless surgery with desired cosmetic results.

Keywords: Skin Adhesive, Surgiseal, scarless, painless, rapid wound healer, 2-Octylcyamoacrylate


Every year there are over 7 million traumatic lacerations [1] and between 26 to 90 million surgical incisions which requires closure by surgeons, emergency physicians, and primary care practitioners [2] Conventionally, these wounds and incisions were closed with sutures, staples, or surgical tapes, but in recent times tissue adhesives are being used frequently. Ideally, a wound closure device should be easy to use, rapid wound healer, painless, result in excellent cosmesis, not require device removal, and be cost-effective. Although none of the presently available closure devices meet all of these needs, but the topical cyanoacrylate tissue adhesives offer many of the characteristics of this ideal wound closure device [3].

Cyanoacrylates was first manufactured in 1949. The first adhesives were found to have an extreme inflammatory effects on tissues. N-butyl-2-cyanoacrylate, which was developed in the 1970s, became the first adhesive to have negligible tissue toxicity and good bonding strength, as well as acceptable wound cosmesis [4].

Surgiseal (2-octylcyanoacrylate), the latest in cyanoacrylate technology, has comparatively less toxicity and almost four times the strength of N-butyl-2-cyanoacrylate [5]. It provides the optimal balance between strength and flexibility. Surgiseal can replace suture that are 5-O or smaller in diameter for incision or laceration repair and is designed to save time during wound repair.

Structure and Mechanical Properties

Generally, the strength and other physical properties of the cyanoacrylate adhesives are directly linked to the length and complexity of their alkyl side chain. Short, straight-chain derivatives (ethyl or butyl cyanoacrylate) form tight and stronger bonds compared with complex or long-chain derivatives (propoxypropyl cyanoacrylate and octylcyanoacrylate) [6].

Octyl cyanoacrylate (OCA) when applied topically degrade slowly, forming few toxic degradation products before the polymers slough off. In theory, the longer the chain (e.g., octyl), the slower the polymer degrades and thus the less probability of cytotoxicity or histotoxicity as the chain length increases.

The heat released during the polymerization of OCA is less as compared to that of BCA because of OCA’s slower rate of polymerization. While a polymer film of OCA is stronger and more flexible, OCA’s setting time is longer than BCA’s in general [7].

SurgiSeal was developed with the goal to improve and enhance 2-OCA’s characteristics as a tissue adhesive. Even though the active ingredient of both SurgiSeal and the leading competitor is 2-OCA, SurgiSeal integrates many innovations in formulation, manufacturing process and applicator design which makes the product stand out in terms of benefits and convenience.

SurgiSeal consists of more than 98% 2-OCA with a trace amount of polymerization accelerator. The 2-OCA is stabilized with a free radical inhibitor and an anionic inhibitor. For visual detection, a trace quantity of the colorant is also included. SurgiSeal is packaged in a user-friendly and single use plastic applicator containing 0.35mL of adhesive. SurgiSeal is sterilized inside the final packaging by a certified sterilization method. The plastic applicator seal is connected to a piece of sponge, allowing the adhesive to be easily dispensed onto the sponge once the sponge connection is folded. A uniform sealing film is formed by applying the adhesive-saturated sponge tip on the wound.

In addition to the chemical, physical and mechanical properties, another practical aspect of cyanoacrylate adhesive is ease of use, which is often related to the applicator design of the adhesive [8].

Medical Application Performances

Adhesive Strength and Flexibility

SurgiSeal has been evaluated for key adhesive properties, such as tensile strength, overlap shear strength, peel adhesive strength and impact strength. The leading competitor also has been evaluated for the same. All the tests were conducted according to the standard methods of ASTM (American Society for Testing and Materials).

SurgiSeal demonstrated strong adhesive strength in all testing. SurgiSeal is significantly stronger in the test of T-Peel loading and is comparable in the tests of Tensile loading, Lap shear tensile loading and Wound closure strength.

Flexibility was also tested using the mandrel bend technique according to ASTM D4338-97. Both SurgiSeal and the leading competitor passed the test and showed no signs of cracks, blistering, blushing, fractures or flaking.

To assess the efficacy of SurgiSeal for the application of incision wound closure, in vivo biomechanical evaluation was performed using the rat linear incision wound model. The average ultimate pressures applied at the wound site for SurgiSeal and the leading competitor were the same, indicating that SurgiSeal possesses bonding strength comparable to the leading competitor’s.

Setting Time

Setting time is also positively correlated to polymerization rate. In general, as per earlier discussion, OCA has a slower polymerization rate as compared to BCA and thus has a longer setting time. To achieve a shorter setting time, a trace amount of an accelerator is added in the formulation of SurgiSeal [9]. The setting time of SurgiSeal is slightly shorter than that of the leading competitor.

Surface Coverage

Applicator dispensing width is defined as the dispensed adhesive width of an individual stroke of an applicator, and the surface coverage area is measured by the applicator dispensing width and length. Both SurgiSeal and the leading competitor were tested on pig skin. The average dispensing width of SurgiSeal was 17.6mm, compared to the 7.7mm average dispensing width of the leading competitor. The average surface coverages of SurgiSeal and the leading competitor were 27.9 and 11.5 inch2, respectively. The tests demonstrate that SurgiSeal can provide much larger and wider coverage per applicator compared to the leading competitor [8].


Adhesives with a high Moisture Vapor Transmission Rate (MVTR) improve wound care [10]. For these tests, MVTR was determined using a Mocon Permatran-W101 Water Vapor Permeability Instrument in accordance with ASTM D-6701. SurgiSeal and the leading competitor were applied and cured on a 2” square collagen film. MVTRs for SurgiSeal and the leading competitor were 2180 and 918 g/m2/day, respectively. SurgiSeal film is more vapor permeable than the leading competitor’s film, which should contribute to better and rapid wound healing.

Ease of Use

The leading competitor’s product is stored in a glass vial that is crushed prior to application. The vial is then squeezed to apply the adhesive smoothly while avoiding dripping of the adhesive. A SurgiSeal applicator can be opened by simply folding the sponge connection thus it is more convenient to use [8].

Faster Wound Sealing

According to the Instruction for Use, the leading competitor requires at least three layers of application [11]. SurgiSeal requires at least two layers of applications on a wound incision. The second layer can be applied after the first layer dries, usually after 30 seconds.

SurgiSeal has a shorter setting time, a wider dispensing width and a larger coverage area, giving it faster wound sealing than the leading competitor [8].

Product Unique Feature

  1. OctylFlex™ Technology: SurgiSeal is manufactured using patented Octyl-Flex Technology. This unique formulation and process provides the optimal balance of the properties that matter most to physician – strength to preserve the integrity of the wound closure and unmatched flexibility for patient comfort and physician control.
  2. Precision Applicator: SurgiSeal patented applicator is designed to provide greater coverage. The self-contained applicator is designed to increase efficiency or to be used on multiple laceration, and to reduce waste.
  3. High Strength Formulation: SurgiSeal adhesive is made up of 2-Octyl Cyanoacrylate formulation which features a greater breaking strength and broader use in clinical application
  4. Microbial barrier/Protective Coating: As, a microbial barrier SurgiSeal adhesive can be used as an auxiliary sealant in conjunction with conventional suture, which can reduce post-operative infection rate
  5. High Moisture Vapor Transmission Rate: The formulation is designed to provide optimal permeability, increasing moisture and oxygen content transmission to the wound in order to gain rapid wound healing [12].

Figure 1: unique product features of SurgiSeal

Cyanoacrylate Adhesives as Topical Wound Dressing

Cyanoacrylate tissue adhesives have been studied extensively compared with sutures and other wound closure agents for topical wound closure and have consistently been shown to produce cosmetic results while improving the speed of closure and being overall less painful [13].

SurgiSeal being a topical skin adhesive has a wide application on various types of surface wounds. It can be effectively used for repairing laceration wound and superficial incision closures.

Lacerations are the wounds seen as a cut on the skin with a blunt, linear or irregular edges. These can be minor or can run upto deep dermal layers. The tension lines across the wound site makes the edges to spread and difficult to heal. Therefore, for proper healing the edges need to come into the close proximity leading to successful wound closure.

SurgiSeal being tissue adhesive in nature helps in keeps the wound edges in place relieving the tension across the wound site. This leads to faster healing, reducing extent of unpleasant scar formation and getting the desired cosmetic outcome. However, the deep dermal wounds require buried suturing to reduce tensile shear forces which may cause premature sloughing. Moreover, the SurgiSeal has smooth covering over the wound with wide area coverage forming the waterproof sealing and providing the antimicrobial barrier [14].

Proper Application of Tissue Adhesive for Topical Wound Closure

Proper wound preparation involves evaluating the patient and the wound for factors that may have an impact on wound healing and the eventual cosmetic outcome. The appropriate use of anesthetics, irrigation, and debridement as well as the method of wound repair can be determined from this evaluation [15].

For the superficial incision closures and repairing laceration wound, apply SurgiSeal as follows:

  1. Prior to use make sure the laceration or incision site is clean and hemostasis is achieved.
  2. For deep dermal wounds, do buried suturing as per the size and depth of wound to reduce the shear tensile forces acting over the wound edges.
  3. Make the patient lie-down and ensure wound is on a horizontal plane to avoid adhesive running into unwanted areas.
  4. Appose the wound edges with fingers, forceps, or skin hooks. Even steri-strips can be used to bring the edges together before applying adhesive. In doing so, they form strong topical bridges over the apposed skin edges of wound, holding them together for 7 to 14 days for normal healing to occur.
  5. Paint the adhesive over the approximated wound edges. Do not push the tip into the wound.
  6. Apply the adhesive in two to three coatings, allowing each coat to dry slightly before reapplying the next layer. Number of layers to be applied depends on clinical site and tension over the wound.
  7. Maintain apposition of the wound for 30 to 60 seconds. Drying of the adhesive usually occurs in 2 to 3 minutes. After polymerization, the wound can be seen under the transparent adhesive.


Figure 2: Method of application for SurgiSeal

Points to be taken care of during application of topical skin adhesive

Complications and poor outcomes with the use of tissue adhesive can be avoided by selecting the proper wounds for closure with adhesives, using dermal sutures where appropriate, and following the proper application techniques. Beside these there are following points to be noted during application [16]:

  1. Hemostasis: It is important in providing a neat, secure wound closure. This can be obtained with dermal sutures where appropriate, pressure on the wound, or the use of vasoconstrictor solutions.
  2. Avoid adhesive getting in the wound: Appose the edges tightly prior to application to ensure that the adhesive do not get inside the wound. If this happens the patient may end up with poor cosmetic results, and it will likely increase the wound infection and dehiscence rate as well.
  3. Avoiding heat: If one thick layer is applied, the heat from the exothermic polymerization may cause a burning discomfort to the patient and, in some cases, a minor thermal injury. The best way to avoid any discomfort caused by the heat is to apply the adhesive in thin layers with multiple strokes.
  4. Controlling the amount of adhesive and run-off: Adhesive being low in viscosity has the tendency to run-off and get into the unwanted areas such as eye.
  5. Erroneous application: If the adhesive gets to an unintended place, it can usually be wiped off before it sets. If it gets into the eye, it can be removed with ophthalmic ointment. On other areas, the adhesive can be removed with acetone; however, care should be taken since acetone should not be used on open wounds because of its histotoxicity.

After Care of the Topical Skin Adhesive

Octyl-cyanoacrylate topical skin adhesive has high tensile strength, it holds the wound edges together and provide microbial protection until the wound heals naturally. The adhesive remains in place for 5-10 days before naturally sloughing off the skin. Keep wounds clean because they are prone to infection for the first 24 to 48 hours after repair [17].

While the wound is healing, aftercare of the wound should be taken properly, as follows:

  1. Regularly check for the appearance of wound. As wound heals, it is common to experience swelling, redness or itching. Therefore, do not pick, scratch, or rub at the adhesive film. Contact doctor if the appearance changes or the wound reopen or edges separates. Protect your skin from injury until the skin has had sufficient time to heal.
  2. Patient may shower or bath immediately after surgery. However, do not soak or scrub the wound, as this can lead to premature sloughing off of the adhesive, leading to wound dehiscence. Do not swim, and avoid periods of heavy perspiration until the adhesive has naturally fallen off. Pat dry the wound area after bathing with soft towel [18]. If necessary, apply a clean, dry bandage over the wound to protect it.
  3. Use of ointments should be avoided. since they act as an emollient which can degrade tissue adhesives as well as cause skin maceration, leading to premature sloughing off of the adhesive.
  4. Avoid prolonged exposure to sunlight and tanning lamps while the film is in place to prevent hyperpigmentation and/or hypertrophic scar formation.
  5. Care should be taken while changing the dressing. Do not place tape over the adhesive film, as when the tape is removed adhesive film gets removed along with it.


Skin and tissue around the wound are sensitive any additional injury in this region leads to more damage. Earlier techniques of wound closure, like suturing and stapling, provides the wound closure but additionally leads the puncturing of the healthy tissues around the wound and also may lead to relocation of microbes on the surface to enter inside the skin. Furthermore, the puncturing of tissues may lead to additional marks and unwanted scar formation. Altogether, these techniques are painful and needs precise expertise to carry out the procedure.

SurgiSeal a topical skin adhesive holds the wound edges together and helps in natural healing of the wound. It also forms the waterproof layer and microbial barrier keeping the infections at check. Its application is painless, easy to learn and can effortlessly be incorporated into physicians practice. The high tensile strength of octyl-cyanoacrylate provides flexibility and freedom to move around. The formula leads to the minimum scar formation and the desired cosmetic results.


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