Not provided
Not provided
Not provided
Not provided
Not provided
Study closed due to recruitment problems
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Reported Pain Using the Visual Analog Scale (VAS) at 2-weeks | 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 VAS Analog Scale. The VAS is a validated, subjective tool for measuring pain intensity, typically consisting of a 10-cm (100-mm) horizontal line anchored by "no pain"(0) and "worst possible pain" (10). Adults mark their pain level on this line, and the distance from the left is measured to determine the score. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenneth Taylor, MD | Penn State Health Milton S Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15253184 | Background | 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. | |
| 9348057 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were recruited during their clinical encounter in the Emergency Room at an academic medical center. The first participant was enrolled on 8/23/2022 and the final patient enrolled on 9/24/2022. The study was kept open for enrollment until 2025 when PI decided to close it due to lack of enrollment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Absorbable Surgical Gut Suture | 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. Absorbable Surgical Gut Suture material: 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. |
| FG001 | Non-absorbable Nylon Suture | 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. Non-absorbable Nylon Suture Material: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Absorbable Surgical Gut Suture | 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. Absorbable Surgical Gut Suture material: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks post-laceration repair |
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Absorbable Surgical Gut Suture | 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. Absorbable Surgical Gut Suture material: 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. |
Not provided
Not provided
Early termination leading to small numbers of subjects enrolled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Taylor, MD | Penn State Milton S. Hershey Medical Center | 717-531-2948 | ktaylor3@pennstatehealth.psu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2024 | Feb 12, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 6, 2024 | Feb 12, 2026 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D022125 | Lacerations |
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Participants will be randomly assigned to either absorbable versus nonabsorbable sutures and compared
Not provided
Not provided
No masking. Both participant and care providers will know group assignment
Not provided
|
| 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. |
|
| 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 |
| 2 weeks post-laceration repair |
| Patient Reported Pain Using the Visual Analog Scale (VAS) at 6-weeks | 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 VAS Analog Scale. The VAS is a validated, subjective tool for measuring pain intensity, typically consisting of a 10-cm (100-mm) horizontal line anchored by "no pain"(0) and "worst possible pain" (10). Adults mark their pain level on this line, and the distance from the left is measured to determine the score. | 6 weeks post-laceration repair |
| Patient Reported Pain Using the Visual Analog Scale (VAS) at 12-weeks | 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 VAS Analog Scale. The VAS is a validated, subjective tool for measuring pain intensity, typically consisting of a 10-cm (100-mm) horizontal line anchored by "no pain"(0) and "worst possible pain" (10). Adults mark their pain level on this line, and the distance from the left is measured to determine the score. | 12 weeks post-laceration repair |
| 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. |
| 15620502 | 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. |
| 15368623 | 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. |
| 11281671 | 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. |
| 19995253 | 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. |
| 22879647 | 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. |
| 30211353 | 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. |
| BG001 | Non-absorbable Nylon Suture | 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. Non-absorbable Nylon Suture Material: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
Absorbable Surgical Gut Suture material: 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.
| OG001 | Non-absorbable Nylon Suture | 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. Non-absorbable Nylon Suture Material: 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 | 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. | 2 subjects from the non-absorbable nylon suture arm did not return for the 6 week appointment despite repeated attempts at contact by the study team. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks post-laceration repair |
|
|
|
| Primary | 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. | 1 subject from the absorbable suture arm and 1 subject from the non-absorbable nylon suture arm did not return for the 12 week follow up appointment despite repeated attempts from the study team. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks post-laceration repair |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks post-laceration repair |
|
|
|
| Primary | 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. | 2 subjects from the non-absorbable nylon suture arm did not return for the 6 week appointment despite repeated attempts at contact by the study team. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks post-laceration repair |
|
|
|
| Primary | 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. | 1 subject from the absorbable suture arm and 1 subject from the non-absorbable suture arm did not return for the 12 week follow up appointment despite repeated calls from the study team. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks post-laceration repair |
|
|
|
| Secondary | Patient Reported Pain Using the Visual Analog Scale (VAS) at 2-weeks | 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 VAS Analog Scale. The VAS is a validated, subjective tool for measuring pain intensity, typically consisting of a 10-cm (100-mm) horizontal line anchored by "no pain"(0) and "worst possible pain" (10). Adults mark their pain level on this line, and the distance from the left is measured to determine the score. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks post-laceration repair |
|
|
|
| Secondary | Patient Reported Pain Using the Visual Analog Scale (VAS) at 6-weeks | 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 VAS Analog Scale. The VAS is a validated, subjective tool for measuring pain intensity, typically consisting of a 10-cm (100-mm) horizontal line anchored by "no pain"(0) and "worst possible pain" (10). Adults mark their pain level on this line, and the distance from the left is measured to determine the score. | 2 subjects from the non-absorbable nylon suture arm did not return for the 6 week follow-up appointment despite repeated efforts by the study team | Posted | Mean | Standard Deviation | score on a scale | 6 weeks post-laceration repair |
|
|
|
| Secondary | Patient Reported Pain Using the Visual Analog Scale (VAS) at 12-weeks | 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 VAS Analog Scale. The VAS is a validated, subjective tool for measuring pain intensity, typically consisting of a 10-cm (100-mm) horizontal line anchored by "no pain"(0) and "worst possible pain" (10). Adults mark their pain level on this line, and the distance from the left is measured to determine the score. | 1 subject from the absorbable Gut suture arm and 1 subject from the non-absorbable nylon suture arm did not return for the 12 week follow-up despite repeated efforts by the study team | Posted | Mean | Standard Deviation | score on a scale | 12 weeks post-laceration repair |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Non-absorbable Nylon Suture | 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. Non-absorbable Nylon Suture Material: 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. | 0 | 2 | 0 | 2 | 0 | 2 |
Not provided
Not provided
Not provided