Arch Hand Microsurg.  2018 Jun;23(2):126-137. 10.12790/ahm.2018.23.2.126.

Effects of a Temperature-sensitive, Anti-adhesive Agent on the Clinical Outcome of Carpal Tunnel Release Surgery

• Cha SM
• Shin HD

• KMID: 2412483
• DOI: http://doi.org/10.12790/ahm.2018.23.2.126

Abstract

PURPOSE
We investigated the anti-adhesive effects of a temperature-sensitive poloxamer/alginate mixture (Guardix-SG®; Hanmi Medicare Inc., Korea) through a prospective randomized controlled study for carpal tunnel release surgery.
METHODS
The 47 patients who received the infusion were classified as Group 1, and the 51 patients who did not were classified as Group 2. Basic demographic factors and preoperative clinical status were evaluated. At the postoperative 18 months, the degree of clinical recovery and adhesion around the median nerve for both groups were evaluated and compared using sonography.
RESULTS
The clinical outcomes, which were assessed using the six-item carpal tunnel symptoms scale, were not significantly different between the groups. However, sonography showed that adhesions around the median nerve were significantly less common in the infusion group.
CONCLUSION
Although the anti-adhesive effects of the temperature-sensitive Guardix-SG® were apparent upon radiological investigation, its use was not associated with a significant difference in clinical outcome on the short-term period follow-up.

Keyword

Carpal tunnel syndrome; Transverse carpal ligament; Anti-adhesive agent

MeSH Terms

Carpal Tunnel Syndrome
Demography
Follow-Up Studies
Humans
Median Nerve
Medicare
Prospective Studies

Figure

• 

  Fig.1. Flow diagram for our randomized controlled study.

• 

  Fig.2. Measurement of the distance between the median nerve and the centre of the scaphoid tubercle. First, we identified the floor of the carpal tunnel made by the carpal bones on the images and found the view with the maximal contour of the tubercle of the scaphoid and pisiform. This view was defined as the adequate image for evaluation of the median nerve mobility. (A) The maximal distance between the median nerve and the scaphoid tubercle was measured with the wrist deviated radially and all fingers extended, in this patient. (B) The minimal distance between the median nerve and the scaphoid tubercle was checked with the wrist held in a neutral position while all four fingers and the thumb were maximally flexed. The differences between the measurements were taken as median nerve movement.

Reference

1.Atroshi I., Gummesson C., Johnsson R., Ornstein E., Rans-tam J., Rosén I. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999. 282:153–8.

2.Mintalucci DJ., Leinberry CF Jr. Open versus endoscopic carpal tunnel release. Orthop Clin North Am. 2012. 43:431–7.

3.Zavala-Rodriguez JM., Correa Rovelo JM., Martinez-Mo-rales N, et al. Oxychlorine species suppress postsurgical adhesions in rats. J Surg Res. 2014. 186:164–9.

4.DiFazio FA., Nichols JB., Pope MH., Frymoyer JW. The use of expanded polytetrafluoroethylene as an interpositional membrane after lumbar laminectomy. Spine (Phila Pa 1976). 1995. 20:986–91.

5.Hellebrekers BW., Trimbos-Kemper TC., Trimbos JB., Emeis JJ., Kooistra T. Use of fibrinolytic agents in the prevention of postoperative adhesion formation. Fertil Steril. 2000. 74:203–12.

6.Liu S., Boutrand JP., Bittoun J., Tadie M. A collagen-based sealant to prevent in vivo reformation of epidural scar adhesions in an adult rat laminectomy model. J Neurosurg. 2002. 97(1 Suppl):69–74.

7.Doig GS., Simpson F. Randomization and allocation con-cealment: a practical guide for researchers. J Crit Care. 2005. 20:187–91. discussion 191-3.

8.Graham B., Regehr G., Naglie G., Wright JG. Development and validation of diagnostic criteria for carpal tunnel syndrome. J Hand Surg Am. 2006. 31:919–24.

9.Bland JD. Treatment of carpal tunnel syndrome. Muscle Nerve. 2007. 36:167–71.

10.Cha SM., Shin HD., Ahn JS., Beom JW., Kim DY. Differences in the postoperative outcomes according to the primary treatment options chosen by patients with carpal tunnel syndrome: conservative versus operative treatment. Ann Plast Surg. 2016. 77:80–4.

11.Wang Y., Zhao C., Passe SM, et al. Transverse ultrasound assessment of median nerve deformation and displace-ment in the human carpal tunnel during wrist movements. Ultrasound Med Biol. 2014. 40:53–61.

12.Park D. Ultrasonography of the transverse movement and deformation of the median nerve and its relationships with electrophysiological severity in the early stages of carpal tunnel syndrome. PM R. 2017. 9:1085–94.

13.Shrout PE., Fleiss JL. Intraclass correlations: uses in as-sessing rater reliability. Psychol Bull. 1979. 86:420–8.

14.Fleiss JL., Cohen J. The equivalence of weighted kappa and the intraclass correlation coefficient as measures of reliability. Educ Psychol Meas. 1973. 33:613–9.

15.Yaacobi Y., Hamed LM., Kaul KS., Fanous MM. Reduction of postoperative adhesions secondary to strabismus surgery in rabbits. Ophthalmic Surg. 1992. 23:123–8.

16.Naito Y., Shin’oka T., Hibino N., Matsumura G., Kurosawa H. A novel method to reduce pericardial adhesion: a com-bination technique with hyaluronic acid biocompatible membrane. J Thorac Cardiovasc Surg. 2008. 135:850–6.

17.Hong JH., Choe JW., Kwon GY, et al. The effects of barrier materials on reduction of pericardial adhesion formation in rabbits: a comparative study of a hyaluronan-based so-lution and a temperature sensitive poloxamer solution/gel material. J Surg Res. 2011. 166:206–13.

18.Manni M., Bisaccia M., Rinonapoli G, et al. Reliability, feasibility and value of ecography in clinical-functional results in patients affected by carpal tunnel syndrome: is there a correlation? Acta Inform Med. 2017. 25:44–8.

19.Shih HN., Fang JF., Chen JH, et al. Reduction in experi-mental peridural adhesion with the use of a crosslinked hyaluronate/collagen membrane. J Biomed Mater Res B Appl Biomater. 2004. 71:421–8.

20.Kim JK., Koh YD., Kim JO., Choi SW. Changes in clinical symptoms, functions, and the median nerve cross-section-al area at the carpal tunnel inlet after open carpal tunnel release. Clin Orthop Surg. 2016. 8:298–302.

21.Park JW., Bak KH., Cho TK., Chun HJ., Ryu JI. Effects of a temperature-sensitive, antiadhesive agent on the reduction of adhesion in a rabbit laminectomy model. J Korean Neurosurg Soc. 2016. 59:250–8.

22.Temel SG., Ozturk C., Temiz A., Ersozlu S., Aydinli U. A new material for prevention of epidural fibrosis after laminectomy: oxidized regenerated cellulose (interceed), an absorbable barrier. J Spinal Disord Tech. 2006. 19:270–5.

23.Park SO., Han J., Minn KW., Jin US. Prevention of capsular contracture with Guardix-SG(®) after silicone implant in-sertion. Aesthetic Plast Surg. 2013. 37:543–8.

24.Moufarrege R., Beauregard G., Bosse JP., Papillon J., Perras C. Outcome of mammary capsulotomies. Ann Plast Surg. 1987. 19:62–4.

25.Leach RE., Burns JW., Dawe EJ., SmithBarbour MD., Dia-mond MP. Reduction of postsurgical adhesion formation in the rabbit uterine horn model with use of hyaluronate/carboxymethylcellulose gel. Fertil Steril. 1998. 69:415–8.

26.Knightly JJ., Agostino D., Cliffton EE. The effect of fibri-nolysin and heparin on the formation of peritoneal adhesions. Surgery. 1962. 52:250–8.

27.Oncel M., Remzi FH., Senagore AJ., Connor JT., Fazio VW. Liquid antiadhesive product (Adcon-p) prevents postoperative adhesions within the intra-abdominal organs in a rat model. Int J Colorectal Dis. 2003. 18:514–7.

28.Presazzi A., Bortolotto C., Zacchino M., Madonia L., Draghi F. Carpal tunnel: Normal anatomy, anatomical variants and ultrasound technique. J Ultrasound. 2011. 14:40–6.