Prospective international multicenter observational study of Novosyn® Quick for skin closures in adults and children (SKINNOQ)

Stefan Gfroerer, Petra Baumann, Anne-Kathrin Schwalbach, Alexandre Smirnoff, Stefan Gfroerer, Petra Baumann, Anne-Kathrin Schwalbach, Alexandre Smirnoff

Abstract

Background: This clinical trial evaluated the performance of a newly released fast-absorbable braided synthetic suture (Novosyn® Quick) in adults and paediatric patients undergoing elective skin closures.

Methods: This was a prospective international multicentre observational study. Two centres enrolled 100 patients, of which 50 were adults (visceral surgery, France) and 50 were paediatric patients (paediatric surgery, Germany). Surgeons used a 5-point Likert scale to assess handling characteristics of the suture. Patients and professionals used the Patient-Observer-Scar-Assessment-Scale (POSAS) to rate scar quality. Adverse events were monitored until 3 months postoperatively.

Results: Handling characteristics of Novosyn® Quick were in median rated very good by both general surgeons and paediatric surgeons. Patient components of POSAS (six questions; ten-level Likert scale; best possible score six) scored in median (range) 8.5 (6-28) in the paediatric group versus 12 (6-38) in the adult group, P = 0.01. Patients` overall opinions of POSAS were similar in both groups [mean (SD), 1.86 (0.99) in the paediatric group versus 2.08 (1.35) in the adult group, P = 0.3536]. Observer component of POSAS (six parameters; ten-level numeric rating scale, best possible score six) scored comparably in both groups [median (range), 8 (6-29) in the paediatric group versus 10 (6-28) in the adult group, P = 0.1403]. Observers overall opinion of POSAS favoured the paediatric patients group [mean (SD), 1.48 (0.61) versus 1.92 (1.06) in the adult group, P = 0.0131]. Adverse events in relation to wound healing were not observed in both patient groups.

Conclusions: Our findings indicate, that Novosyn® Quick is safe and reliable for skin closure in adults and paediatric patients and can be regarded as a viable alternative to Vicryl® Rapide.

Trial registration: This trial was registered prospectively with ClinicalTrials.gov under the registration number NCT02680886 on 5 February 2016. The trial was approved by the Institutional Review Boards of both study locations (France: CCTIRS N° 16-103 and CNIL:MMS/CWR/AR163920; Germany: 398/15).

Keywords: Fast-absorbable braided suture; Paediatric; Skin closure.

Conflict of interest statement

Stefan Gfroerer, Anne-Kathrin Schwalbach and Alexandre Smirnoff declare that they have no competing interests. Petra Baumann is an employee of Aesculap AG.

Figures

Fig. 1
Fig. 1
Adult patients and paediatric patients flow diagram
Fig. 2
Fig. 2
Box plot of intraoperative handling characteristics of Novosyn® Quick
Fig. 3
Fig. 3
a Exemplary photodocumentation of an adult patient´ scar (62 year old patient, inguinal hernia repair) and b paediatric patient´ scar (5½ months old infant, inguinal hernia repair) at 3 months postoperative assessment

References

    1. Matsumine H, Takeuchi M. Usefulness of irradiated Polyglactin 910 (Vicryl Rapide) for skin suturing during surgery for lateral ray polydactyly of the toes in children. Plast Reconstr Surg Glob Open. 2013;1:e42. doi: 10.1097/GOX.0b013e3182a85b13.
    1. Tejani C, Sivitz AB, Rosen MD, Nakanishi AK, Flood RG, Clott MA, Saccone PG, Luck RP. A comparison of cosmetic outcomes of lacerations on the extremities and trunk using absorbable versus nonabsorbable sutures. Acad Emerg Med. 2014;21:637–643. doi: 10.1111/acem.12387.
    1. Theopold C, Potter S, Dempsey M, O'Shaughnessy M. A randomised controlled trial of absorbable versus non-absorbable sutures for skin closure after open carpal tunnel release. J Hand Surg Eur. 2012;37:350–353. doi: 10.1177/1753193411422334.
    1. Tandon SC, Kelly J, Turtle M, Irwin ST. Irradiated polyglactin 910: a new synthetic absorbable suture. J R Coll Surg Edinb. 1995;40:185–187.
    1. Aderriotis D, Sàndor GK. Outcomes of irradiated polyglactin 910 Vicryl Rapide fast-absorbing suture in oral and scalp wounds. J Can Dent Assoc. 1999;65:345–347.
    1. Sidebottom AJ, Grogan J, May P, Richardson D. Prospective comparison of methods of closure of the coronal flap after craniofacial surgery in children. Br J Oral Maxillofac Surg. 2003;41:309–311. doi: 10.1016/S0266-4356(03)00143-8.
    1. Ekerot L. Correction of syndactyly: advantages with a non-grafting technique and the use of absorbable skin sutures. Scand J Plast Reconstr Surg Hand Surg. 1999;33:427–431. doi: 10.1080/02844319950159154.
    1. Niessen FB, Spauwen PH, Kon M. The role of suture material in hypertrophic scar formation: Monocryl vs. Vicryl-rapide. Ann Plast Surg. 1997;39:254–260. doi: 10.1097/00000637-199709000-00006.
    1. Al-Qattan MM. Vicryl Rapide versus Vicryl suture in skin closure of the hand in children: a randomized prospective study. J Hand Surg Br. 2005;30:90–91. doi: 10.1016/J.JHSB.2004.08.005.
    1. Parell GJ, Becker GD. Comparison of absorbable with nonabsorbable sutures in closure of facial skin wounds. Arch Facial Plast Surg. 2003;5:488–490. doi: 10.1001/archfaci.5.6.488.
    1. Brackeen AR, Wells MJ, Freed JM. Irradiated polyglactin 910 (Vicryl Rapide) for placement of full-thickness skin grafts. Dermatol Surg. 2005;31:1707–1709.
    1. Howard K, Simison AJ, Morris A, Bhalaik V. A prospective randomised trial of absorbable versus non-absorbable sutures for wound closure after fasciectomy for Dupuytren's contracture. J Hand Surg Eur Vol. 2009;34:618–620. doi: 10.1177/1753193409105728.
    1. Duprez K, Bilweis J, Duprez A, Merle M. Experimental and clinical study of fast absorption cutaneous suture material. Ann Chir Main. 1988;7:91–96. doi: 10.1016/S0753-9053(88)80077-2.
    1. Canarelli JP, Ricard J, Collet LM, Marasse E. Use of fast absorption material for skin closure in young children. Int Surg. 1988;73:151–152.
    1. Martelli H, Catena D, Rahon H, Boukheloua B, Wicart F, Pellerin D. Skin sutures in pediatric surgery. Use of a fast-resorption synthetic thread. Presse Med. 1991;20:2194–2198.
    1. Szabó S, István G. Skin closure in inguinal hernia repair with rapidly absorbing Polyglactin910/370 (Vicryl-Rapide) suture material. Magy Seb. 2002;55:77–80.
    1. Missori P, Polli FM, Fontana E, Delfini R. Closure of skin or scalp with absorbable sutures. Plast Reconstr Surg. 2003;112:924–925. doi: 10.1097/01.PRS.0000074497.87004.2D.
    1. Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004;113:1960–1965. doi: 10.1097/01.PRS.0000122207.28773.56.
    1. van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the patient and observer scar assessment scale. Plast Reconstr Surg. 2005;116:514–522. doi: 10.1097/01.prs.0000172982.43599.d6.
    1. Truong PT, Lee JC, Soer B, Gaul CA, Olivotto IA. Reliability and validity testing of the patient and observer scar assessment scale in evaluating linear scars after breast cancer surgery. Plast Reconstr Surg. 2007;119:487–494. doi: 10.1097/01.prs.0000252949.77525.bc.
    1. Vercelli S, Ferriero G, Sartorio F, Stissi V, Franchignoni F. How to assess postsurgical scars: a review of outcome measures. Disabil Rehabil. 2009;31:2055–2063. doi: 10.3109/09638280902874196a.
    1. Falder S, Browne A, Edgar D, Staples E, Fong J, Rea S, Wood F. Core outcomes for adult burn survivors: a clinical overview. Burns. 2009;35:618–641. doi: 10.1016/j.burns.2008.09.002.
    1. Idriss N, Maibach HI. Scar assessment scales: a dermatologic overview. Skin Res Technol. 2009;15:1–5. doi: 10.1111/j.1600-0846.2008.00327.x.

Source: PubMed

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