Surgical WoundNCT05261425
Suture Closure Trial
A study testing Monocryl buried and Nylon (FDA Approved) not buried in people with Surgical Wound and Upper Extremity Injury, run by Emory University at 3 sites in United States.
Trial summary
Closure of surgical incisions in orthopedic procedures contributes to patient postoperative pain and risk of complication. As the focus on improving orthopedic surgery outcomes shifts to best practices in postoperative pain management, it is important to consider suture types and techniques. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Surgical Wound, Upper Extremity Injury
- What is being tested?
- Monocryl buried and Nylon (FDA Approved) not buried
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Feb 2024to 5 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing surgery for upper extremity injury (finger, hand, wrist, elbow, shoulder)
- Patients aged 18 to 99-years-old who are willing and able to provide informed consent
Who cannot join
- Adults unable to give consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory Orthopedic and Spine Hospital
Atlanta, Georgia, 30084
Emory Executive Park
Atlanta, Georgia, 30329
Emory Orthopaedics and Spine Center
Atlanta, Georgia, 30329
About this study
Official title: Incision Closure for Orthopedic Procedures
Closure of surgical incisions in orthopedic procedures contributes to patient postoperative pain and risk of complication. As the focus on improving orthopedic surgery outcomes shifts to best practices in postoperative pain management, it is important to consider suture types and techniques.
This study specifically would focus on comparing different suture types and techniques and their efficacy. This will be a randomized controlled trial comparing currently used, standard of care suture types and currently used, standard of care suture techniques to identify differences, if any exist, in postoperative pain scores and wound healing as assessed by exam and postoperative patient surveys. Patients will be identified by the Emory Upper Extremity/Hand Surgeons as they are identified as a candidate for surgery. Participants will then be informed of the study and spoken to about the specifics of the study. The research team will consent and recruit patients either in The Emory Clinic or in the preoperative area prior to surgery. All surgical operations will take place at the ambulatory surgical center in The Emory Clinic or at the Emory University Orthopaedic and Spine Hospital. Patients will not be compensated for participation in this study. No specimens/data/samples will be collected and stored for later use, and there are no optional substudies. This proposed study will address the lack of published literature regarding the suture technique in hand and wrist surgery in particular. Combined with examining various suture materials, the proposal has the potential to provide a valuable and actionable base of knowledge to the current body of literature.
Read the detailed description
The purpose of this study is to evaluate the efficacy of different standard-of-care FDA Approved suture types and techniques.
The use of sutures in primary closure of surgical incisions is standard of care for all surgical specialties, including surgery of the hand and wrist. When controlling for type of wound, wound depth, and desired tension, the type of suture selected and technique in which it is applied may vary depending on factors such as surgeon preference and training background.
Addressing different suture types: A variety of suture types are currently in use as the standard of care for the closure of surgical incisions. These are primarily categorized by the composition of absorbable and non-absorbable materials, and further by subtype into braided (vicryl and vicryl Rapide absorbable; ethibond and silk non-absorbable) versus monofilament suture structure (monocryl, polydioxanone, and gut absorbable; ethilon and prolene non-absorbable), or alternatively by synthetic versus natural material composition. As suture types vary in their elasticity, plasticity, memory, and tensile strength, there have been multiple studies assessing the difference in various outcomes between the use of absorbable and non-absorbable suture materials for incision closure after wrist and hand surgery, predominantly after carpal tunnel release. Addressing different suture techniques: There is significantly less evidence regarding different suturing techniques for incision closure after upper extremity surgery. In fact, there exist no studies assessing outcomes from different suture techniques for hand or wrist surgery at all. This proposed study will address the lack of published literature regarding the suture technique in hand and wrist surgery in particular. Combined with examining various suture materials, the proposal has the potential to provide a valuable and actionable base of knowledge to the current body of literature. The research team will randomize patients at each endpoint into cohorts for their orthopedic upper extremity surgical procedure. The PI/Co-Investigators will provide primary closure via suture in the operating room with the cooperation of their surgical team to the normal standard of care for wound closure. The research team will coordinate with scrub technicians and nursing staff to ensure that each patient receives the correctly randomized suture or technique for closure by the surgeon. The patient will then be asked questionnaires to evaluate their satisfaction with their wound closure and will be assessed by the surgeon as well.
The study device sutures will continue to be stored in the operating room and will only be accessed at the time of surgery following standard of care operating protocols
- Conditions
- Surgical Wound, Upper Extremity Injury
- Being tested
- Monocryl buried, Nylon (FDA Approved) not buried
- Keywords
- Sutures, surgical technique
- Medical subject headings
- Surgical Wound, Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monocryl buriedDevice
Participants randomized to this group will receive the Monocryl (suture) buried (technique). The surgeon will utilize the randomized material and technique, and the research team will utilize two surveys postoperatively to assess wound healing and appearance. Participants will fill out these surveys at each of their clinical follow-up visits.
Nylon (FDA Approved) not buriedDevice
Participants randomized to this group will receive the Nylon (FDA Approved) (suture), not buried (technique). The surgeon will utilize the randomized material and technique, and the research team will utilize two surveys postoperatively to assess wound healing and appearance. Participants will fill out these surveys at each of their clinical follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Monocryl buried | Active comparator | Upper extremity primary surgical wound closure via suture with Monocryl buried Receives: Device: Monocryl buried |
| Nylon (FDA Approved) not buried | Active comparator | Upper extremity primary surgical wound closure via suture with Nylon(FDA Approved) not buried Receives: Device: Nylon (FDA Approved) not buried |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in participant's pain score
Participants will be asked to complete questionnaires to evaluate their pain at each follow-up visit. The Visual Analog Scale will be the subjective measurement to evaluate changes in pain scores, with values ranging from 0 (no pain) to 10 (very severe pain). A higher score indicates worse pain.
Measured: Post-operative follow-up up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start5 Feb 2024
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Wagner, Emory University
- Investigators
- Eric R Wagner, MD, MS, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261425
- Sponsor's protocol ID
- STUDY00002251
- Other IDs
- 2025P013345
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2022
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incision Closure for Orthopedic Procedures
- ClinicalTrials.gov ID
- NCT05261425
- Acronym / sponsor ID
- STUDY00002251
- Conditions
- Surgical Wound, Upper Extremity Injury
- Keywords
- Sutures, surgical technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Closure of surgical incisions in orthopedic procedures contributes to patient postoperative pain and risk of complication. As the focus on improving orthopedic surgery outcomes shifts to best practices in postoperative pain management, it is important to consider suture types and techniques.
This study specifically would focus on comparing different suture types and techniques and their efficacy. This will be a randomized controlled trial comparing currently used, standard of care suture types and currently used, standard of care suture techniques to identify differences, if any exist, in postoperative pain scores and wound healing as assessed by exam and postoperative patient surveys. Patients will be identified by the Emory Upper Extremity/Hand Surgeons as they are identified as a candidate for surgery. Participants will then be informed of the study and spoken to about the specifics of the study. The research team will consent and recruit patients either in The Emory Clinic or in the preoperative area prior to surgery. All surgical operations will take place at the ambulatory surgical center in The Emory Clinic or at the Emory University Orthopaedic and Spine Hospital. Patients will not be compensated for participation in this study. No specimens/data/samples will be collected and stored for later use, and there are no optional substudies. This proposed study will address the lack of published literature regarding the suture technique in hand and wrist surgery in particular. Combined with examining various suture materials, the proposal has the potential to provide a valuable and actionable base of knowledge to the current body of literature.
Detailed description
The purpose of this study is to evaluate the efficacy of different standard-of-care FDA Approved suture types and techniques.
The use of sutures in primary closure of surgical incisions is standard of care for all surgical specialties, including surgery of the hand and wrist. When controlling for type of wound, wound depth, and desired tension, the type of suture selected and technique in which it is applied may vary depending on factors such as surgeon preference and training background.
Addressing different suture types: A variety of suture types are currently in use as the standard of care for the closure of surgical incisions. These are primarily categorized by the composition of absorbable and non-absorbable materials, and further by subtype into braided (vicryl and vicryl Rapide absorbable; ethibond and silk non-absorbable) versus monofilament suture structure (monocryl, polydioxanone, and gut absorbable; ethilon and prolene non-absorbable), or alternatively by synthetic versus natural material composition. As suture types vary in their elasticity, plasticity, memory, and tensile strength, there have been multiple studies assessing the difference in various outcomes between the use of absorbable and non-absorbable suture materials for incision closure after wrist and hand surgery, predominantly after carpal tunnel release. Addressing different suture techniques: There is significantly less evidence regarding different suturing techniques for incision closure after upper extremity surgery. In fact, there exist no studies assessing outcomes from different suture techniques for hand or wrist surgery at all. This proposed study will address the lack of published literature regarding the suture technique in hand and wrist surgery in particular. Combined with examining various suture materials, the proposal has the potential to provide a valuable and actionable base of knowledge to the current body of literature. The research team will randomize patients at each endpoint into cohorts for their orthopedic upper extremity surgical procedure. The PI/Co-Investigators will provide primary closure via suture in the operating room with the cooperation of their surgical team to the normal standard of care for wound closure. The research team will coordinate with scrub technicians and nursing staff to ensure that each patient receives the correctly randomized suture or technique for closure by the surgeon. The patient will then be asked questionnaires to evaluate their satisfaction with their wound closure and will be assessed by the surgeon as well.
The study device sutures will continue to be stored in the operating room and will only be accessed at the time of surgery following standard of care operating protocols
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monocryl buried | Active comparator | Device: Monocryl buriedUpper extremity primary surgical wound closure via suture with Monocryl buried |
| Nylon (FDA Approved) not buried | Active comparator | Device: Nylon (FDA Approved) not buriedUpper extremity primary surgical wound closure via suture with Nylon(FDA Approved) not buried |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing surgery for upper extremity injury (finger, hand, wrist, elbow, shoulder)
- Patients aged 18 to 99-years-old who are willing and able to provide informed consent
Key exclusion criteria (4 listed)
- Adults unable to give consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monocryl buriedParticipants randomized to this group will receive the Monocryl (suture) buried (technique). The surgeon will utilize the randomized material and technique, and the research team will utilize two surveys postoperatively to assess wound healing and appearance. Participants will fill out these surveys at each of their clinical follow-up visits. | Device | Monocryl buried |
| Nylon (FDA Approved) not buriedParticipants randomized to this group will receive the Nylon (FDA Approved) (suture), not buried (technique). The surgeon will utilize the randomized material and technique, and the research team will utilize two surveys postoperatively to assess wound healing and appearance. Participants will fill out these surveys at each of their clinical follow-up visits. | Device | Nylon (FDA Approved) not buried |
Primary outcome
Change in participant's pain score
Time frame: Post-operative follow-up up to 3 months
Participants will be asked to complete questionnaires to evaluate their pain at each follow-up visit. The Visual Analog Scale will be the subjective measurement to evaluate changes in pain scores, with values ranging from 0 (no pain) to 10 (very severe pain). A higher score indicates worse pain.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Surgical Wound
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
Not yet recruitingPhase 4
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
Surgical Wound Infection, Neck Infection
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Not yet recruitingObservational study
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
Acute Kidney Injury, Intra-Abdominal Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric R Wagner, MD, MS principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monocryl buried and Nylon (FDA Approved) not buried in people with Surgical Wound and Upper Extremity Injury, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participant's pain score (time frame: Post-operative follow-up up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.