Laceration of Forearm, Laceration of Hand
Conditions
Keywords
laceration, wound, absorbable, non-absorbable, hand, forearm
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.
Interventions
DEVICEAbsorbable 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.
DEVICENon-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.
Sponsors
Kenneth Taylor, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking. Both participant and care providers will know group assignment
Intervention model description
Participants will be randomly assigned to either absorbable versus nonabsorbable sutures and compared
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score in Wound Healing From Surgery to 2 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion | 2 weeks post-laceration repair | 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. |
| Score in Wound Healing From Surgery 6 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion | 6 weeks post-laceration repair | 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. |
| Score in Wound Healing From Surgery 12 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion | 12 weeks post-laceration repair | 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. |
| Score in Wound Healing From Surgery to 2 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Observer Portion | 2 weeks post-laceration repair | 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. |
| Score in Wound Healing From Surgery 6 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Observer Portion | 6 weeks post-laceration repair | 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. |
| Score in Wound Healing From Surgery 12 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Observer Portion | 12 weeks post-laceration repair | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Pain Using the Visual Analog Scale (VAS) at 2-weeks | 2 weeks post-laceration repair | 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. |
| Patient Reported Pain Using the Visual Analog Scale (VAS) at 6-weeks | 6 weeks post-laceration repair | 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. |
| Patient Reported Pain Using the Visual Analog Scale (VAS) at 12-weeks | 12 weeks post-laceration repair | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKenneth Taylor, MD
Penn State Health Milton S Hershey Medical Center
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 2 |
| other Total, other adverse events | 0 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 4 | 0 / 2 |
Outcome results
None listed