Clinical trial NCT05281666: Suture Repair of Lacerations in the ED: Comparison Between Two Suture Materials
Official title: Suture Repair of Lacerations in the Emergency Department: Comparison Between Absorbable and Non-absorbable Suture Material
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Laceration of Hand
Laceration of Forearm
Keywords: laceration
wound
absorbable
non-absorbable
hand
forearm
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either absorbable versus non-absorbable sutures and compared
Primary purpose: TREATMENT

Brief summary: This study aims to determine whether the use of non-absorbable (i.e. nylon) versus absorbable (i.e. chromic gut) sutures in traumatic hand lacerations affects wound healing, patient perception, and development of complications.

Detailed description: There has been limited data published on suture type in traumatic hand wounds. The only study we found in our literature review was a retrospective study comparing vicryl vs. nylon suture and found no difference in scar appearance, tenderness, retraction, or complications as far as 6 months after repair (2). There have been no prospective studies on this topic. The theoretical advantage of absorbable suture for these wounds is they do not require suture removal, thereby removing the discomfort of suture removal as well potentially decreasing the burden of follow-up.

At the Penn State Health Hershey Medical Center, either suture choice included in this study is considered standard of care and is routinely used. Selection as to whether absorbable or non-absorbable suture is used is based on the preference and discretion of the resident and attending surgeon involved in the patient care. As such, if a patient were to present to the emergency department with a forearm or hand laceration and hand surgery were consulted, regardless of whether the patient opts to participate in this research study, their laceration would be repaired with either absorbable or non-absorbable suture depending on provider preference and the patient would be scheduled follow-up.

There have been multiple prospective clinical trials on suture type in the context of planned surgical incisions, specifically carpal tunnel release, with variable outcomes. One clinical trial looking at a total of 40 incisions found no difference in pain, tenderness, inflammation, or outcomes postoperatively (3). Certain clinical trials favored non-absorbable sutures, reporting a higher rate of infection (4) or inflammation (5) with vicryl suture as compared to non-braided, non-absorbable sutures. On the other hand, other clinical trials favored absorbable sutures, describing reduction in pain scores (6) and pain associated with absorbable suture removal in the setting of other equivalent outcomes (7).

The purpose of the study is to evaluate the use of absorbable and non-absorbable suture material in hand lacerations repaired in the Penn State Health Milton S. Hershey Emergency Department.

Eligibility criteria: Inclusion Criteria:

* Subject seen in PSHMC Emergency Department for hand or forearm lacerations (i.e. laceration below the level of the elbow) that require suture repair, in which Hand Surgery is consulted
* CDC surgical wound classification grades I-IV
* Age \>18 years of age
* Gender: male or female (non-pregnant)
* Fluent in written and spoken English
* Subject is able to provide voluntary, written informed consent
* Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits
* Non-Prisoners

Exclusion Criteria:

* Known allergy to suture material
* History of immunosuppression (i.e. concurrent chemotherapy, steroid use or immunomodulatory therapy)
* History of diabetes mellitus
* Pregnancy
* Current Tobacco use
* Age \< 18 years old
* Previous skin laceration at same location
* History of previous hypertrophic or keloid scar
* Concurrent tendon, nerve or bone injury requiring trip to the operating room
* Non-English speaking patients
* Cognitive impairment
* Prisoners

Primary outcomes:
measure: Change in wound healing using the Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient reported pain using the Visual Analog Scale (VAS)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State Health Milton S Hershey Medical Center
name: Kenneth Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.
citation: Shetty PC, Dicksheet S, Scalea TM. Emergency department repair of hand lacerations using absorbable vicryl sutures. J Emerg Med. 1997 Sep-Oct;15(5):673-4. doi: 10.1016/s0736-4679(97)00147-9.
citation: Kharwadkar N, Naique S, Molitor PJ. Prospective randomized trial comparing absorbable and non-absorbable sutures in open carpal tunnel release. J Hand Surg Br. 2005 Feb;30(1):92-5. doi: 10.1016/j.jhsb.2004.10.009.
citation: Menovsky T, Bartels RH, van Lindert EL, Grotenhuis JA. Skin closure in carpal tunnel surgery: a prospective comparative study between nylon, polyglactin 910 and stainless steel sutures. Hand Surg. 2004 Jul;9(1):35-8. doi: 10.1142/s0218810404002017.
citation: Erel E, Pleasance PI, Ahmed O, Hart NB. Absorbable versus non-absorbable suture in carpal tunnel decompression. J Hand Surg Br. 2001 Apr;26(2):157-8. doi: 10.1054/jhsb.2000.0545.
citation: Hansen TB, Kirkeby L, Fisker H, Larsen K. Randomised controlled study of two different techniques of skin suture in endoscopic release of carpal tunnel. Scand J Plast Reconstr Surg Hand Surg. 2009;43(6):335-8. doi: 10.1080/02844310902955763.
citation: Freshwater MF. 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: 350-3. J Hand Surg Eur Vol. 2012 Sep;37(7):705; author reply 705-6. doi: 10.1177/1753193412454501. No abstract available.
citation: Onyekwelu I, Yakkanti R, Protzer L, Pinkston CM, Tucker C, Seligson D. Surgical Wound Classification and Surgical Site Infections in the Orthopaedic Patient. J Am Acad Orthop Surg Glob Res Rev. 2017 Jun 13;1(3):e022. doi: 10.5435/JAAOSGlobal-D-17-00022. eCollection 2017 Jun.