Wound Complication Hand SurgeryNCT04812275
Absorbable or Non Absorbable Sutures in Hand Surgery
A study testing Skin closure in people with Wound Complication Hand Surgery, run by Department of Hand surgery Södersjukhuset at 1 site in Sweden.
Trial summary
After all surgical procedures, the skin must be closed with some form of stitch, in healthcare called suture. According to the tradition of hand surgery, sutures that must be removed by caregivers, ie non-resorbable thread, have been used extensively, and the frequency of complications in the form of wound rupture and… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Wound Complication Hand Surgery
- What is being tested?
- Skin closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSweden
- Study dates
- 19 Apr 2021to 11 Nov 2023
- 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 consecutive patients> 18 years of age who are operated on at the hand surgery clinic Södersjukhuset for elective or emergency surgery that do not meet any of the exclusion criteria.
Who cannot join
- -The researcher has an age <18 years.
- Patients with known healing problems in the past, for example patients with burns or during cortisone treatment.
- Patients undergoing surgery where skin grafting occurs.
- Patients with acute injuries that include a traumatic wound-ie what is usually referred to as "open injuries" -where the risk of infection is higher from the beginning.
Trial locations and contacts
1 site in 1 country.
About this study
After all surgical procedures, the skin must be closed with some form of stitch, in healthcare called suture. According to the tradition of hand surgery, sutures that must be removed by caregivers, ie non-resorbable thread, have been used extensively, and the frequency of complications in the form of wound rupture and infection is low. For many procedures, however, it can be an advantage to avoid removing the stitches, as it is both painful for the patient and time-consuming and resource-consuming for both the patient and the healthcare system. You can then use a thread that the body itself breaks down and absorbs, ie resorbable suture. In the project, we will compare resorbable and non-resorbable suture with the primary outcome of superficial infection in the surgical area sometime day 1-20 after surgery. Secondary outcomes are the occurrence of wound rupture, pain VAS (Visual Analog Scale) when changing 2 weeks postoperatively, patient satisfaction VAS at 2 weeks and time spent in minutes for changing at 2 weeks postoperatively. The project will include all consecutive patients> 18 years of age who are operated on at the hand surgery clinic Södersjukhuset for elective or emergency surgery that do not meet the exclusion criteria. The project will include 270 patients.
- Conditions
- Wound Complication Hand Surgery
- Being tested
- Skin closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin closureProcedure or surgery
Skin closure
| Study group | Role | What they receive |
|---|---|---|
| Non absorbable suture | Active comparator | Wound closure with non absorbale suture. Dimension and brand at the discretion of the surgeon. Receives: Procedure: Skin closure |
| Absorbable suture | Experimental | Wound closure with absorbale suture. Dimension and brand at the discretion of the surgeon. Receives: Procedure: Skin closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection
Signs of superficial infection after surgery. Redness, pus, swelling.
Measured: 2 weeks
Secondary outcomes (3)
Rupture
The prevalens of wound rupture after hand surgery
Measured: 2 weeks
VAS
Visual analog scale
Measured: 2 weeks
Time
Time consumption removal of sutures
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start19 Apr 2021
- Primary completion10 Nov 2023
- Study completion11 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound Complication Hand SurgeryStudies of the same condition, open and under way.
- 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
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Hand surgery Södersjukhuset
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirjam Hägg, Department of Hand surgery Södersjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812275
- Sponsor's protocol ID
- 2020-06004
- Status last verified
- Dec 2023
- First submitted
- 26 Feb 2021
- Last updated
- 15 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hagg M, Mellstrand Navarro C, von Kieseritzky J. Absorbable sutures reduce pain without compromising wound healing in open clinic hand surgery. J Orthop Surg Res. 2026 Aug 22;21(1):536. doi: 10.1186/s13018-026-07159-7.
PubMed 42702723
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorbable or Non Absorbable Sutures in Hand Surgery
- ClinicalTrials.gov ID
- NCT04812275
- Acronym / sponsor ID
- 2020-06004
- Conditions
- Wound Complication Hand Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Department of Hand surgery SödersjukhusetUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 11 Nov 2023 (actual)
- First posted
- 23 Mar 2021 (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.
After all surgical procedures, the skin must be closed with some form of stitch, in healthcare called suture. According to the tradition of hand surgery, sutures that must be removed by caregivers, ie non-resorbable thread, have been used extensively, and the frequency of complications in the form of wound rupture and infection is low. For many procedures, however, it can be an advantage to avoid removing the stitches, as it is both painful for the patient and time-consuming and resource-consuming for both the patient and the healthcare system. You can then use a thread that the body itself breaks down and absorbs, ie resorbable suture. In the project, we will compare resorbable and non-resorbable suture with the primary outcome of superficial infection in the surgical area sometime day 1-20 after surgery. Secondary outcomes are the occurrence of wound rupture, pain VAS (Visual Analog Scale) when changing 2 weeks postoperatively, patient satisfaction VAS at 2 weeks and time spent in minutes for changing at 2 weeks postoperatively. The project will include all consecutive patients> 18 years of age who are operated on at the hand surgery clinic Södersjukhuset for elective or emergency surgery that do not meet the exclusion criteria. The project will include 270 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non absorbable suture | Active comparator | Procedure: Skin closureWound closure with non absorbale suture. Dimension and brand at the discretion of the surgeon. |
| Absorbable suture | Experimental | Procedure: Skin closureWound closure with absorbale suture. Dimension and brand at the discretion of the surgeon. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all consecutive patients> 18 years of age who are operated on at the hand surgery clinic Södersjukhuset for elective or emergency surgery that do not meet any of the exclusion criteria.
Key exclusion criteria (4 listed)
- -The researcher has an age <18 years.
- Patients with known healing problems in the past, for example patients with burns or during cortisone treatment.
- Patients undergoing surgery where skin grafting occurs.
- Patients with acute injuries that include a traumatic wound-ie what is usually referred to as "open injuries" -where the risk of infection is higher from the beginning.
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 |
|---|---|---|
| Skin closureSkin closure | Procedure or surgery | Absorbable suture, Non absorbable suture |
Primary outcome
Infection
Time frame: 2 weeks
Signs of superficial infection after surgery. Redness, pus, swelling.
3 secondary outcomes
Rupture
Time frame: 2 weeks
VAS
Time frame: 2 weeks
Time
Time frame: 2 weeks
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 15 Dec 2023.
- Derived from this study: PubMed 42702723Hagg M, Mellstrand Navarro C, von Kieseritzky J. Absorbable sutures reduce pain without compromising wound healing in open clinic hand surgery. J Orthop Surg Res. 2026 Aug 22;21(1):536. doi: 10.1186/s13018-026-07159-7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin closure in people with Wound Complication Hand Surgery, run by Department of Hand surgery Södersjukhuset at 1 site in Sweden.
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 1 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 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Infection (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04812275, which also lists 1 linked publication.
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 15 Dec 2023.