Trial Outcomes & Findings for Suture Repair of Lacerations in the ED: Comparison Between Two Suture Materials (NCT NCT05281666)
NCT ID: NCT05281666
Last Updated: 2026-03-17
Results Overview
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.
TERMINATED
NA
6 participants
2 weeks post-laceration repair
2026-03-17
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Absorbable Surgical Gut Suture
n=4 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.
|
Non-absorbable Nylon Suture
n=2 Participants
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.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=4 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=4 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=4 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=6 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
2 participants
n=2 Participants
|
6 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 2 weeks post-laceration repairPatients 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.
Outcome measures
| Measure |
Absorbable Surgical Gut Suture
n=4 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.
|
Non-absorbable Nylon Suture
n=2 Participants
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.
|
|---|---|---|
|
Score in Wound Healing From Surgery to 2 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion
|
25 score on a scale
Standard Deviation 11.8
|
24 score on a scale
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: 6 weeks post-laceration repairPopulation: 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.
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.
Outcome measures
| Measure |
Absorbable Surgical Gut Suture
n=4 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.
|
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.
|
|---|---|---|
|
Score in Wound Healing From Surgery 6 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion
|
12 score on a scale
Standard Deviation 5.3
|
—
|
PRIMARY outcome
Timeframe: 12 weeks post-laceration repairPopulation: 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.
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.
Outcome measures
| Measure |
Absorbable Surgical Gut Suture
n=3 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.
|
Non-absorbable Nylon Suture
n=1 Participants
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.
|
|---|---|---|
|
Score in Wound Healing From Surgery 12 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion
|
9 score on a scale
Standard Deviation 4.4
|
9 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 2 weeks post-laceration repairPatients 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.
Outcome measures
| Measure |
Absorbable Surgical Gut Suture
n=4 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.
|
Non-absorbable Nylon Suture
n=2 Participants
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.
|
|---|---|---|
|
Score in Wound Healing From Surgery to 2 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Observer Portion
|
23 score on a scale
Standard Deviation 10.5
|
22.5 score on a scale
Standard Deviation 7.8
|
PRIMARY outcome
Timeframe: 6 weeks post-laceration repairPopulation: 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.
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.
Outcome measures
| Measure |
Absorbable Surgical Gut Suture
n=4 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.
|
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.
|
|---|---|---|
|
Score in Wound Healing From Surgery 6 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Observer Portion
|
13.3 score on a scale
Standard Deviation 7.5
|
—
|
PRIMARY outcome
Timeframe: 12 weeks post-laceration repairPopulation: 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.
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.
Outcome measures
| Measure |
Absorbable Surgical Gut Suture
n=3 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.
|
Non-absorbable Nylon Suture
n=1 Participants
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.
|
|---|---|---|
|
Score in Wound Healing From Surgery 12 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Observer Portion
|
14.3 score on a scale
Standard Deviation 13.6
|
12 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 2 weeks post-laceration repairPatients 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.
Outcome measures
| Measure |
Absorbable Surgical Gut Suture
n=4 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.
|
Non-absorbable Nylon Suture
n=2 Participants
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.
|
|---|---|---|
|
Patient Reported Pain Using the Visual Analog Scale (VAS) at 2-weeks
|
1.9 score on a scale
Standard Deviation 0.8
|
2.8 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 6 weeks post-laceration repairPopulation: 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
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.
Outcome measures
| Measure |
Absorbable Surgical Gut Suture
n=4 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.
|
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.
|
|---|---|---|
|
Patient Reported Pain Using the Visual Analog Scale (VAS) at 6-weeks
|
0.48 score on a scale
Standard Deviation 0.6
|
—
|
SECONDARY outcome
Timeframe: 12 weeks post-laceration repairPopulation: 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
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.
Outcome measures
| Measure |
Absorbable Surgical Gut Suture
n=3 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.
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Non-absorbable Nylon Suture
n=1 Participants
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.
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Patient Reported Pain Using the Visual Analog Scale (VAS) at 12-weeks
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0.033 score on a scale
Standard Deviation 0.06
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1 score on a scale
Standard Deviation 0
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Adverse Events
Absorbable Surgical Gut Suture
Non-absorbable Nylon Suture
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kenneth Taylor, MD
Penn State Milton S. Hershey Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place