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

NCT05281666 | Terminated Results FDA Device

• 1 other identifier: STUDY00019465
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Laceration of Hand; Laceration of Forearm

Keywords

laceration; wound; absorbable; non-absorbable; hand; forearm

Outcome Measures

Primary Outcomes (6)

• Score in Wound Healing From Surgery to 2 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion

  Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department and complete the Patient and Observer Scar Assessment Scale (POSAS). The assigned blinded observer also completes this survey. Scores are obtained from both the subject and observer at 2 weeks, 6 weeks, and 12 weeks. The Patient and Observer Scar Assessment Scale (POSAS) evaluates scars and consists of two 6-item, 10-point scales (1 = normal skin, 10 = worst scar imaginable) for both patients and observers. Scores for each scale range from 6 to 60, where higher scores indicate poorer scar quality. Both scales include an overall opinion item, which is not included in the sum score.

  2 weeks post-laceration repair

• Score in Wound Healing From Surgery 6 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion

  Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department and complete the Patient and Observer Scar Assessment Scale (POSAS). The assigned blinded observer also completes this survey. Scores are obtained from both the subject and observer at 2 weeks, 6 weeks, and 12 weeks. The Patient and Observer Scar Assessment Scale (POSAS) evaluates scars and consists of two 6-item, 10-point scales (1 = normal skin, 10 = worst scar imaginable) for both patients and observers. Scores for each scale range from 6 to 60, where higher scores indicate poorer scar quality. Both scales include an overall opinion item, which is not included in the sum score.

  6 weeks post-laceration repair

• Score in Wound Healing From Surgery 12 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion

  Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department and complete the Patient and Observer Scar Assessment Scale (POSAS). The assigned blinded observer also completes this survey. Scores are obtained from both the subject and observer at 2 weeks, 6 weeks, and 12 weeks. The Patient and Observer Scar Assessment Scale (POSAS) evaluates scars and consists of two 6-item, 10-point scales (1 = normal skin, 10 = worst scar imaginable) for both patients and observers. Scores for each scale range from 6 to 60, where higher scores indicate poorer scar quality. Both scales include an overall opinion item, which is not included in the sum score.

  12 weeks post-laceration repair

• Score in Wound Healing From Surgery to 2 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Observer Portion

  Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department and complete the Patient and Observer Scar Assessment Scale (POSAS). The assigned blinded observer also completes this survey. Scores are obtained from both the subject and observer at 2 weeks, 6 weeks, and 12 weeks. The Patient and Observer Scar Assessment Scale (POSAS) evaluates scars and consists of two 6-item, 10-point scales (1 = normal skin, 10 = worst scar imaginable) for both patients and observers. Scores for each scale range from 6 to 60, where higher scores indicate poorer scar quality. Both scales include an overall opinion item, which is not included in the sum score.

  2 weeks post-laceration repair

• Score in Wound Healing From Surgery 6 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Observer Portion

  Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department and complete the Patient and Observer Scar Assessment Scale (POSAS). The assigned blinded observer also completes this survey. Scores are obtained from both the subject and observer at 2 weeks, 6 weeks, and 12 weeks. The Patient and Observer Scar Assessment Scale (POSAS) evaluates scars and consists of two 6-item, 10-point scales (1 = normal skin, 10 = worst scar imaginable) for both patients and observers. Scores for each scale range from 6 to 60, where higher scores indicate poorer scar quality. Both scales include an overall opinion item, which is not included in the sum score.

  6 weeks post-laceration repair

• Score in Wound Healing From Surgery 12 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Observer Portion

  Patients return to the practice site at 2 weeks, 6 weeks, and 12 weeks after their initial visit to the Emergency Department and complete the Patient and Observer Scar Assessment Scale (POSAS). The assigned blinded observer also completes this survey. Scores are obtained from both the subject and observer at 2 weeks, 6 weeks, and 12 weeks. The Patient and Observer Scar Assessment Scale (POSAS) evaluates scars and consists of two 6-item, 10-point scales (1 = normal skin, 10 = worst scar imaginable) for both patients and observers. Scores for each scale range from 6 to 60, where higher scores indicate poorer scar quality. Both scales include an overall opinion item, which is not included in the sum score.

  12 weeks post-laceration repair

Secondary Outcomes (3)

• Patient Reported Pain Using the Visual Analog Scale (VAS) at 2-weeks

  2 weeks post-laceration repair

• Patient Reported Pain Using the Visual Analog Scale (VAS) at 6-weeks

  6 weeks post-laceration repair

• Patient Reported Pain Using the Visual Analog Scale (VAS) at 12-weeks

  12 weeks post-laceration repair

Study Arms (2)

Absorbable Surgical Gut Suture

ACTIVE COMPARATOR

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.

Device: Absorbable Surgical Gut Suture material

Non-absorbable Nylon Suture

ACTIVE COMPARATOR

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.

Device: Non-absorbable Nylon Suture Material

Interventions

Absorbable Surgical Gut Suture material DEVICE

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.

Absorbable Surgical Gut Suture

Non-absorbable Nylon Suture Material DEVICE

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.

Non-absorbable Nylon Suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kenneth Taylor, M.D.: lead

Study Sites (1)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (8)

• 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.

  PMID: 15253184 BACKGROUND

• 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.

  PMID: 9348057 BACKGROUND

• 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.

  PMID: 15620502 BACKGROUND

• 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.

  PMID: 15368623 BACKGROUND

• 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.

  PMID: 11281671 BACKGROUND

• 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.

  PMID: 19995253 BACKGROUND

• 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.

  PMID: 22879647 BACKGROUND

• 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.

  PMID: 30211353 BACKGROUND

MeSH Terms

Conditions

Lacerations; Wounds and Injuries

Limitations and Caveats

Early termination leading to small numbers of subjects enrolled.

Results Point of Contact

• Title: Kenneth Taylor, MD
• Organization: Penn State Milton S. Hershey Medical Center

ktaylor3@pennstatehealth.psu.edu

717-531-2948

Study Officials

• Kenneth Taylor, MD

  Penn State Health Milton S Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking. Both participant and care providers will know group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Orthopaedics and Rehabilitation

Model Details: Participants will be randomly assigned to either absorbable versus nonabsorbable sutures and compared

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: August 23, 2022
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: March 17, 2026
• Results First Posted: March 17, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)