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A Prospective, Randomized, Multicenter Trial Assessing a Novel Lysine-Derived Urethane Adhesive in a Large Flap Surgical Procedure without Drains.

ABSTRACT: To evaluate the safety and effectiveness of a lysine-derived urethane adhesive as a noninvasive alternative to closed suction drains in a commonly performed large flap surgical procedure.One hundred thirty subjects undergoing abdominoplasty at five centers were prospectively randomized to standard flap closure with surgical drains (Control group) or a lysine-derived urethane adhesive (Treatment group) without drains. The primary outcome measured was the number of post-operative procedures, including drain removals (as the event marking the use of a surgical drain) and needle aspirations. Secondary endpoints included total wound drainage, cumulative days of treatment, and days to drain removal. A patient questionnaire evaluating quality of life measures was also administered.Subjects in the Treatment group required significantly fewer post-operative procedures compared to the Control group (1.8 ± 3.8 vs. 2.4 ± 1.2 procedures; p < 0.0001) and fewer cumulative days of treatment (1.6 ± 0.4 vs. 7.3 ± 3.3; p < 0.0001). A procedure to address fluid accumulation was required for only 27.3 % of the subjects in the Treatment group versus 100 % of Control group, which by study design required the use of drains. The mean duration of use of indwelling surgical drains for the Control group was 6.9 ± 3.3 days. All fluid collections treated with percutaneous aspiration were resolved and there were no unanticipated adverse events.The results of the study support that the use of a lysine-derived urethane adhesive is a safe and effective alternative to drains in patients undergoing a common large flap surgical procedure.

SUBMITTER: Hunstad JP

PROVIDER: S-EPMC4503854 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

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A Prospective, Randomized, Multicenter Trial Assessing a Novel Lysine-Derived Urethane Adhesive in a Large Flap Surgical Procedure without Drains.

Hunstad Joseph P JP Michaels Joseph J Burns A Jay AJ Slezak Sheri S Stevens W Grant WG Clower Dottie M DM Rubin J Peter JP

Aesthetic plastic surgery 20150605 4

<h4>Objective</h4>To evaluate the safety and effectiveness of a lysine-derived urethane adhesive as a noninvasive alternative to closed suction drains in a commonly performed large flap surgical procedure.<h4>Methods</h4>One hundred thirty subjects undergoing abdominoplasty at five centers were prospectively randomized to standard flap closure with surgical drains (Control group) or a lysine-derived urethane adhesive (Treatment group) without drains. The primary outcome measured was the number o ...[more]

PMID: 26044391

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Project description:ObjectiveTitanium plates and screws (TPS) are the current standard of care for fixation of cranial bone flaps. These materials have been used for decades but have known potential complications, including flap migration, bone resorption/incomplete osseous union, hardware protrusion, cosmetic deformity, wound infection/dehiscence, and cerebrospinal fluid (CSF) leakage. This study evaluated the efficacy of a novel mineral-organic bone adhesive (Tetranite) for cranial bone flap fixation.MethodsCraniotomy bone flaps created in human cadaveric skulls were tested under quasistatic and impact loading in the following conditions: 1) uncut skull; 2) bone flaps fixated with TPS alone; and 3) bone flaps fixated with bone adhesive alone. All fixative surgical procedures were performed by a group of 16 neurosurgeons in a simulated surgical environment. The position of adhesive-fixated cranial bone flaps was measured using computed tomography and compared with their original native location. The resistance of adhesive-fixated cranial bone flaps to simulated CSF leakage was also evaluated. Because there was a gap around the circumference of the TPS-fixated specimens that was visible to the naked eye, pressurized CSF leak testing was not attempted on them.ResultsAdhesive-fixated bone flaps showed significantly stiffer and stronger quasistatic responses than TPS-fixated specimens. The strength and stiffness of the adhesive-fixated specimens were not significantly different from those of the uncut native skulls. Total and plastic deflections under 6-J impact were significantly less for adhesive-fixed bone flaps than TPS. There were no significant differences in any subthreshold impact metrics between the adhesive-fixed and native specimens at both 6-J and 12-J impact levels, with 1 exception. Plastic deflection at 6-J impact was significantly less in adhesive-fixated bone flaps than in native specimens. The energy to failure of the adhesive-fixated specimens was not significantly different from that of the native specimens. Time since fixation (20 minutes vs 10 days) did not significantly affect the impact failure properties of the adhesive-fixated specimens. Of the 16 adhesive-fixated craniotomy specimens tested, 14 did not leak at pressures as high as 40 mm Hg.ConclusionsThe neurosurgeons in this study had no prior exposure or experience with the bone adhesive. Despite this, improved resistance to CSF egress, superior mechanical properties, and better cosmetic outcomes were demonstrated with bone adhesive compared with TPS.

Dataset Information

A Prospective, Randomized, Multicenter Trial Assessing a Novel Lysine-Derived Urethane Adhesive in a Large Flap Surgical Procedure without Drains.

Publications

A Prospective, Randomized, Multicenter Trial Assessing a Novel Lysine-Derived Urethane Adhesive in a Large Flap Surgical Procedure without Drains.

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