Randomized clinical trial of a new cyanoacrylate flexible tissue adhesive (Adhflex) for repairing surgical wounds

Lloris‐Carsí, José Miguel; Ballester‐Álvaro, Jaime; Barrios, Carlos; Zaragozá‐Fernández, Cristobal; Cruz, Carlos Gómez‐De la; González‐Cuartero, Chelo; Prieto‐Moure, Beatriz; Cejalvo‐Lapeña, Dolores

doi:10.1111/wrr.12424

Cited by 11 publications

(13 citation statements)

References 47 publications

(54 reference statements)

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“…Cosmetic outcome was also evaluated at the 1-and 4-week visit by POSAS and MHCS (Table 2). Wounds were judged slightly better in the 11.43 (10)(11)(12)(13) .005…”

Section: Resultsmentioning

confidence: 98%

A randomised clinical trial to compare octyl cyanoacrylate with absorbable monofilament sutures for the closure of laparoscopic cholecystectomy port incisions

Safta

Marrakchi

Bouzidi

et al. 2019

International Wound Journal

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Tissue adhesives have gained increasing use as a possible method of wound closure. We compared the use of 2‐octyl cyanoacrylate (OCA) or subcuticular suture in incisions sutures for the closure of laparoscopic cholecystectomy port incisions. A prospective randomised controlled trial was performed. Patients were randomised to have closure of laparoscopic port sites using either OCA or sutures. Patients were reviewed at 24 hours and returned for follow‐up 1 week and 1 month after postoperatively. At these times, different wound characteristics were documented: Two tools were used to measure the cosmetic result using Hollander wound evaluation scale (HWES) and the patient and observer scar assessment scale (POSAS). A total of 70 patients, 35 in each group were enrolled. The wounds were closed significantly faster in the OCA group (mean 229.16 [±43.7] seconds versus 258.82 [±51.7] seconds, P = .01). Statistically significant difference in favour of using OCA was found for dehiscence (17.1% versus none in the suture group, P = .025) after 1 week. However, no difference was found for wound dehiscence after 1 month. OCA and suture groups did not differ significantly on patient satisfaction. There were no differences in the percentage of wounds achieving optimal scores on the HWES (suture 85.7% versus OCA 74.2%, P = .169). Nerveless, wound evolution was judged to be significantly better in the OCA group using POSAS. Patients' median POSAS was 9.45 (6–11) and 11.43 (10–13) in the OCA and suture groups, respectively (P = .005), and surgeon's median POSAS was 9.42 (6–11) and 11.48 (10–13) in the OCA and suture groups, respectively (P = .006). N‐butyl‐cyanoacrylate tissue adhesive is an acceptable technique for the closure of laparoscopic wounds with less operative time, and cosmetic results are comparable to suturing.

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“…Cosmetic outcome was also evaluated at the 1-and 4-week visit by POSAS and MHCS (Table 2). Wounds were judged slightly better in the 11.43 (10)(11)(12)(13) .005…”

Section: Resultsmentioning

confidence: 98%

A randomised clinical trial to compare octyl cyanoacrylate with absorbable monofilament sutures for the closure of laparoscopic cholecystectomy port incisions

Safta

Marrakchi

Bouzidi

et al. 2019

International Wound Journal

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“…The degradation process of both TachoSil and GelitaSpon does not entails generation of non-physiologic toxic products. However, the superior adhesiveness and clotting speed showed by Adhflex in previous studies as compared to conventional treatments, suggest that this new elastic cyanoacrylate should be considered a useful sealant substance [19,20]. …”

Section: Discussionmentioning

confidence: 99%

“…Additionally, a peritoneal perilesional inflammatory reaction was observed, preventing possible bleeding recurrences in the early stages of healing [19]. Therefore, considering renal trauma injuries as an emergency, any rapid sealant, such as Adhflex, should be considered as a treatment option [19, 20]. …”

Section: Discussionmentioning

confidence: 99%

The effect of biological sealants and adhesive treatments on matrix metalloproteinase expression during renal injury healing

et al. 2017

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BackgroundRenal injuries are relatively common in cases of abdominal trauma. Adhesives and sealants can be used to repair and preserve damaged organs. Using a rat model, this study explores the activity of different matrix metalloproteinases (MMP) during the healing of renal injuries treated by two biological adhesives (TachoSil and GelitaSpon) and a new synthetic elastic cyanoacrylate (Adhflex).MethodsRenal traumatic injuries were experimentally induced in 90 male Wistar rats by a Stiefel Biopsy Punch in the anterior aspect of the left kidney. Animals were divided into five groups: 1, sham non-injured (n = 3); 2, non-treated standard punch injury (n = 6); 3, punch injury treated with TachoSil (n = 27); 4, punch injury treated with GelitaSpon (n = 27); and, 5, punch injury treated with Adhflex (n = 27). Wound healing was evaluated 2, 6, and 18 days after injury by determining the expression of MMPs, and the histopathological evolution of lesions.FindingsHistologically, the wound size at 6 days post-injury was larger in Adhflex-treated samples than in the other treatments, but the scarring tissue was similar at 18 days post-injury. Only the MMPs subtypes 1, 2, 8, 9, and 13 were sufficiently expressed to be quantifiable. Both time since injury and treatment type had a significant influence on MMPs expression. Two days after injury, the expression of MMP8 and MMP9 was predominant. MMP2 expression was greater 6 days after injury. The Adhflex-treated group had a significantly higher MMPs expression than the other treatment groups at all healing stages.ConclusionsAll three sealant treatments induced almost similar expression of MMPs than untreated animals indicating a physiological healing process. Given that all renal trauma injuries must be considered emergencies, both biological and synthetic adhesives, such as Adhflex, should be considered as a treatment options.

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“…MMPs are a family of proteases that use zinc-dependent catalysis to break down ECM glycoprotein, which allows cells to move and tissue to reorganize [20]. Currently, there is strong evidence that MMPs play key roles in the healing process, especially during the inflammatory and proliferative phase [10][11][12][13].…”

Section: Introductionmentioning

confidence: 99%

Tracking the Healing Process of Experimental Liver Injuries Treated with Different Sealants and Adhesive Biomaterials: An Evaluation of Matrix Metalloproteinase

Lloris‐Carsí¹,

Barrios²,

Lloris-Cejalvo³

et al. 2018

Preprint

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This study examines the matrix metalloproteinase (MMP) activity in the healing of liver injuries treated with biological adhesives Tachosil® and GelitaSpon® and the elastic cyanoacrylate Adhflex®. Hepatic lesions were induced in male rats using a Stiefel biopsy punch. Healing was assessed 2, 6, and 18 days after injury by quantifying tissue levels of MMP1, 2, 8, 9, and 13. Histopathological repair was evaluated using hematoxylin-eosin, Masson’s trichrome, and Periodic Acid Schiff (PAS) staining and immunohistochemical markers CD31 and CD68. The sealants contributed to complete healing. Histopathology and MMP findings indicate that Adhflex® has slower degradation and a strong inflammatory reaction at the onset of healing. Early on, all MMPs showed higher levels in Adhflex® and Tachosil®-treated animals, and MMP2 and MMP9 expressions were significantly higher in the Adhflex-treated group at 18 days post-injury (T3). The Adhflex® group had significantly higher MMP8 and MPP13 levels than other treated groups and showed a sustained overexpression of all MMPs, even in the latest healing stages. Notably, the overexpression did not negatively influence the histological healing process. All hepatic trauma injuries should be treated as emergencies, and any easy-to-use and rapid sealant like Adhflex® could be considered as an option for treating liver trauma.

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Randomized clinical trial of a new cyanoacrylate flexible tissue adhesive (Adhflex) for repairing surgical wounds

Abstract: Eudra CT2012-002701-22.

Cited by 11 publications

References 47 publications

A randomised clinical trial to compare octyl cyanoacrylate with absorbable monofilament sutures for the closure of laparoscopic cholecystectomy port incisions

A randomised clinical trial to compare octyl cyanoacrylate with absorbable monofilament sutures for the closure of laparoscopic cholecystectomy port incisions

The effect of biological sealants and adhesive treatments on matrix metalloproteinase expression during renal injury healing

Tracking the Healing Process of Experimental Liver Injuries Treated with Different Sealants and Adhesive Biomaterials: An Evaluation of Matrix Metalloproteinase

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