Study Summary
This trial will compare the outcomes of using Vicryl Rapide suture to nonabsorbable suture for repairing lacerations on the trunk or extremities of adults.
Eligible Conditions
- Traumatic Lacerations
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 3-Month
3-Month
The two treatments will be compared by a noninferiority test
30-days
Percentage of patients needing further treatment
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
Absorbable
1 of 2
Nonabsorbable
1 of 2
Active Control
96 Total Participants · 2 Treatment Groups
Primary Treatment: Absorbable · No Placebo Group · N/A
Absorbable
Device
ActiveComparator Group · 1 Intervention: Vicryl Rapide absorbable suture · Intervention Types: DeviceNonabsorbableNoIntervention Group · 1 Intervention: Nonabsorbable · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3-month
Who is running the clinical trial?
Central California Faculty Medical GroupOTHER
2 Previous Clinical Trials
547 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,347 Previous Clinical Trials
11,783,016 Total Patients Enrolled
Brian Chinnock, MDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
929 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have one cut on your body or limb that needs stitches to close.
Your cut is longer than 2 centimeters.
The wound can be closed using basic stitches.
References
- Holger, Joel S, Steve C Wandersee, and David B Hale. 2004. “Cosmetic Outcomes of Facial Lacerations Repaired with Tissue-adhesive, Absorbable, and Nonabsorbable Sutures”. The American Journal of Emergency Medicine. Elsevier BV. doi:10.1016/j.ajem.2004.02.009.
- Sajid, M.S., U. Parampalli, M.K. Baig, and M.R. McFall. 2011. “A Systematic Review on the Effectiveness of Slowly-absorbable Versus Non-absorbable Sutures for Abdominal Fascial Closure Following Laparotomy”. International Journal of Surgery. Elsevier BV. doi:10.1016/j.ijsu.2011.09.006.
- Quinn, J.V, A.E Drzewiecki, I.G Stiell, and T.J Elmslie. 1995. “Appearance Scales to Measure Cosmetic Outcomes of Healed Lacerations”. The American Journal of Emergency Medicine. Elsevier BV. doi:10.1016/0735-6757(95)90100-0.
- Singer, Adam J.. 1998. “Clinical Wound Evaluation Scales”. Academic Emergency Medicine. Wiley. doi:10.1111/j.1553-2712.1998.tb02461.x.
- Karounis, Helen, Serge Gouin, Harley Eisman, Dominic Chalut, Helene Pelletier, and Bruce Williams. 2004. “A Randomized, Controlled Trial Comparing Long-term Cosmetic Outcomes of Traumatic Pediatric Lacerations Repaired with Absorbable Plain Gut Versus Nonabsorbable Nylon Sutures”. Academic Emergency Medicine. Wiley. doi:10.1197/j.aem.2003.12.029.
- Brown, J. Kristine, Brendan T. Campbell, Robert A. Drongowski, Amy K. Alderman, James D. Geiger, Daniel H. Teitelbaum, James Quinn, Arnold G. Coran, and Ronald B. Hirschl. 2009. “A Prospective, Randomized Comparison of Skin Adhesive and Subcuticular Suture for Closure of Pediatric Hernia Incisions: Cost and Cosmetic Considerations”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1016/j.jpedsurg.2009.02.051.
- Luck, Raemma, Trevor Tredway, James Gerard, Dalit Eyal, Lauren Krug, and Robert Flood. 2013. “Comparison of Cosmetic Outcomes of Absorbable Versus Nonabsorbable Sutures in Pediatric Facial Lacerations”. Pediatric Emergency Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/pec.0b013e3182948f26.
- Murphy, Paul G., Ezzat Tadros, Simon Cross, Dermot Hehir, Paul E. Burke, Patrick Kent, Stephen J. Sheehan, Mary Paula Colgan, Dermot J. Moore, and Gregor D. Shanik. 1995. “Skin Closure and the Incidence of Groin Wound Infection: A Prospective Study”. Annals of Vascular Surgery. Elsevier BV. doi:10.1007/bf02143863.
- Quinn, James V., and George A. Wells. 1998. “An Assessment of Clinical Wound Evaluation Scales”. Academic Emergency Medicine. Wiley. doi:10.1111/j.1553-2712.1998.tb02465.x.
- Luck, Raemma P., Robert Flood, Dalit Eyal, John Saludades, Ciana Hayes, and John Gaughan. 2008. “Cosmetic Outcomes of Absorbable Versus Nonabsorbable Sutures in Pediatric Facial Lacerations”. Pediatric Emergency Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/pec.0b013e3181666f87.
- Mouzas, G L, and A Yeadon. 1975. “Does the Choice of Suture Material Affect the Incidence of Wound Infection? A Comparison of Dexon (polyglycolic Acid) Sutures with Other Commonly Used Sutures in an Accident and Emergency Department”. British Journal of Surgery. Oxford University Press (OUP). doi:10.1002/bjs.1800621207.
- Tejani, Cena, Adam B. Sivitz, Micheal D. Rosen, Albert K. Nakanishi, Robert G. Flood, Mathew A. Clott, Paul G. Saccone, and Raemma P. Luck. 2014. “A Comparison of Cosmetic Outcomes of Lacerations on the Extremities and Trunk Using Absorbable Versus Nonabsorbable Sutures”. Edited by Shahriar Zehtabchi. Academic Emergency Medicine. Wiley. doi:10.1111/acem.12387.
- Quinn JV, Drzewiecki AE, Stiell IG, Elmslie TJ. Appearance scales to measure cosmetic outcomes of healed lacerations. Am J Emerg Med. 1995 Mar;13(2):229-31. doi: 10.1016/0735-6757(95)90100-0.
- Murphy PG, Tadros E, Cross S, Hehir D, Burke PE, Kent P, Sheehan SJ, Colgan MP, Moore DJ, Shanik GD. Skin closure and the incidence of groin wound infection: a prospective study. Ann Vasc Surg. 1995 Sep;9(5):480-2. doi: 10.1007/BF02143863.
- Holger JS, Wandersee SC, Hale DB. Cosmetic outcomes of facial lacerations repaired with tissue-adhesive, absorbable, and nonabsorbable sutures. Am J Emerg Med. 2004 Jul;22(4):254-7. doi: 10.1016/j.ajem.2004.02.009.
- Karounis H, Gouin S, Eisman H, Chalut D, Pelletier H, Williams B. A randomized, controlled trial comparing long-term cosmetic outcomes of traumatic pediatric lacerations repaired with absorbable plain gut versus nonabsorbable nylon sutures. Acad Emerg Med. 2004 Jul;11(7):730-5. doi: 10.1197/j.aem.2003.12.029.
- Mouzas GL, Yeadon A. Does the choice of suture material affect the incidence of wound infection? A comparison of dexon (polyglycolic acid) sutures with other commonly used sutures in an accident and emergency department. Br J Surg. 1975 Dec;62(12):952-5. doi: 10.1002/bjs.1800621207.
- Singer AJ. Clinical wound evaluation scales. Acad Emerg Med. 1998 Jun;5(6):564-6. doi: 10.1111/j.1553-2712.1998.tb02461.x. No abstract available.
- Quinn JV, Wells GA. An assessment of clinical wound evaluation scales. Acad Emerg Med. 1998 Jun;5(6):583-6. doi: 10.1111/j.1553-2712.1998.tb02465.x.
- Lundblad R, Simensen HV, Wiig JN, Niels Gruner OP. [Skin closure. A prospective randomized study]. Tidsskr Nor Laegeforen. 1989 Apr 30;109(12):1307-9. Norwegian.
- 2019. "Vicryl Rapide Versus Nonabsorbable Suture". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04056013.
Frequently Asked Questions
Are applications still being received for this research endeavor?
"Affirmative. According to records available on clinicaltrials.gov, this investigation was published on September 26th 2019 and is currently looking for 96 volunteers from 2 locations. It has been recently updated as of March 28th 2022." - Anonymous Online Contributor
Unverified Answer
What is the cap on participants for this clinical research?
"Affirmative. According to clinicaltrials.gov, this clinical trial is currently enrolling subjects for participation. It was first posted on September 26th 2019 and the most recent update happened on March 28th 2022; 96 patients are needed between two sites in total." - Anonymous Online Contributor
Unverified Answer