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Suture Repair of Lacerations in the ED: Comparison Between Two Suture Materials

Primary Purpose

Laceration of Hand, Laceration of Forearm

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Absorbable Surgical Gut Suture material
Non-absorbable Nylon Suture Material
Sponsored by
Kenneth Taylor, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laceration of Hand focused on measuring laceration, wound, absorbable, non-absorbable, hand, forearm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Health Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Absorbable Surgical Gut Suture

Non-absorbable Nylon Suture

Arm Description

Ethicon Chromic Surgical Gut Suture Is an absorbable, sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) Intestines. Surgical Gut Suture is Indicated for use In general soft tissue approximation and/or ligation, including use In ophthalmic procedures, but not for use in cardiovascular and neurologic tissues.

Ethicon ETHILON* nylon suture is a nonabsorbab\e, sterile surgical monofi\ament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. ETHILON sutures are dyed black or green to enhance visibility in tissue. The suture is also available undyed (clear). ETHILON suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Outcomes

Primary Outcome Measures

Change in wound healing using the Patient and Observer Scar Assessment Scale (POSAS)
Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department

Secondary Outcome Measures

Patient reported pain using the Visual Analog Scale (VAS)
Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department

Full Information

First Posted
March 7, 2022
Last Updated
June 6, 2023
Sponsor
Kenneth Taylor, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT05281666
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Taylor, M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laceration of Hand, Laceration of Forearm
Keywords
laceration, wound, absorbable, non-absorbable, hand, forearm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to either absorbable versus non-absorbable sutures and compared
Masking
None (Open Label)
Masking Description
No masking. Both participant and care providers will know group assignment
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Absorbable Surgical Gut Suture
Arm Type
Active Comparator
Arm Description
Ethicon Chromic Surgical Gut Suture Is an absorbable, sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) Intestines. Surgical Gut Suture is Indicated for use In general soft tissue approximation and/or ligation, including use In ophthalmic procedures, but not for use in cardiovascular and neurologic tissues.
Arm Title
Non-absorbable Nylon Suture
Arm Type
Active Comparator
Arm Description
Ethicon ETHILON* nylon suture is a nonabsorbab\e, sterile surgical monofi\ament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. ETHILON sutures are dyed black or green to enhance visibility in tissue. The suture is also available undyed (clear). ETHILON suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Intervention Type
Device
Intervention Name(s)
Absorbable Surgical Gut Suture material
Intervention Description
Participants with lacerations below the level of the forearm that meet inclusion criteria and are consented and randomized to this group will undergo washout and laceration repair using absorbable surgical gut suture material. They will be sent home with antibiotics. They will be asked to return to the outpatient hand clinic at 2, 6, and 12 weeks follow-up. Their wound will be assessed by a single observer, utilizing the POSAS and VAS.
Intervention Type
Device
Intervention Name(s)
Non-absorbable Nylon Suture Material
Intervention Description
Participants with lacerations below the level of the forearm that meet inclusion criteria and are consented and randomized to this group will undergo washout and laceration repair using non-absorbable nylon gut suture material. They will be sent home with antibiotics. They will be asked to return to the outpatient hand clinic at 2, 6, and 12 weeks follow-up. Their sutures will be removed at the 2-week follow-up visit. Their wound will be assessed by a single observer, utilizing the POSAS and VAS.
Primary Outcome Measure Information:
Title
Change in wound healing using the Patient and Observer Scar Assessment Scale (POSAS)
Description
Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Patient reported pain using the Visual Analog Scale (VAS)
Description
Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Taylor, MD
Organizational Affiliation
Penn State Health Milton S Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15253184
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.
Results Reference
background
PubMed Identifier
9348057
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.
Results Reference
background
PubMed Identifier
15620502
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.
Results Reference
background
PubMed Identifier
15368623
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.
Results Reference
background
PubMed Identifier
11281671
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.
Results Reference
background
PubMed Identifier
19995253
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.
Results Reference
background
PubMed Identifier
22879647
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.
Results Reference
background
PubMed Identifier
30211353
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.
Results Reference
background

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Suture Repair of Lacerations in the ED: Comparison Between Two Suture Materials

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