Suture; Complications, MechanicalNCT05267002
Comparing 1 Week Versus 2 Week Cutaneous Suture Removal
A study testing Suture removal timing in people with Suture; Complications, Mechanical and Scar, run by DermSurgery Associates at 1 site in United States.
Trial summary
Our goal is to compare the difference in surgical outcomes and patient satisfaction for surgical scars on the face between suture removal at 1 week versus 2 weeks. There is variation in the timing at which Mohs surgeons remove sutures on the face. Some prefer 1 week, and others prefer 2 weeks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suture; Complications, Mechanical, Scar, Surgery
- What is being tested?
- Suture removal timing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2022to 24 May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria i. Adult patients >18 years ii. Undergoing Mohs surgery or excision with layered repair
- intermediate or complex layered closures measuring 2.6-7.5 cm on the face (including the forehead, temples, nose, cheeks, chin)
- Wound edges must be able to be approximated with subcutaneous sutures. iii. Ability to follow up at 1 week, 2 weeks, 2 months, and 1 year iv. Participants able to be enrolled at time of wound repair.
Exclusion criteria i. Facial defects involving the eyelid, mucosal lip, and ear ii. Pregnant or breastfeeding women iii. Children <18 years iv. Inability to comprehend English v. Inability to consent vi. Incarceration
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
DermSurgery Associates
Houston, Texas, 77030
Maria Hartley, 713-791-9966 ext. 122, mariam@dermsurgery.org
About this study
Official title: One Week Versus Two Week Removal of Nylon Cutaneous Sutures for Linear Layered Closures on the Face: a Randomized Evaluator-blinded Prospective Split-scar Trial
Our goal is to compare the difference in surgical outcomes and patient satisfaction for surgical scars on the face between suture removal at 1 week versus 2 weeks.
There is variation in the timing at which Mohs surgeons remove sutures on the face. Some prefer 1 week, and others prefer 2 weeks. This has not been formally studied. It is possible the outcomes are the same between both groups, or that one has a better cosmetic outcome than the other.
Your skin cancer will be removed as usual. After this, your wound will be sutured in the usual fashion, except the top sutures will be divided into two separate halves. You will return at 1 week for one half of the top sutures to be removed, and at 2 weeks for the other half to be removed. Which half is removed first will be determined at random at your 1 week visit. At two months, you will return for standardized photographs which will be used by physicians to rate the cosmetic outcomes of the wound halves based on a standardized scale. Most likely, there will be no difference between the wound halves at 2 months and the study is complete. There is a small chance that there will be a cosmetic difference seen at 2 months, in which case you will return at 1 year for repeat standardized photographs and ratings. All data and photographs will be kept secure and any identifying information will be destroyed at the end of the study.
Read the detailed description
This is an investigator initiated, single-center, prospective, randomized, evaluator-blinded split-scar study. Subjects will be recruited at the time of repair for Mohs surgery or excision based on the inclusion criteria above. Procedures will be performed by fellowship trained Mohs surgeons or fellows in training. The same surgeon will close the entire wound. At the time of wound closure, the wound will be divided into two equal halves. Subcutaneous 4-0 or 5-0 polyglecaprone sutures will be used to fully approximate the wound edges. Subcutaneous sutures will begin with one subcutaneous suture immediately in the center of the wound, followed by symmetrical subcutaneous sutures on both sides of the defect until the wound edges are approximated.
Once the wound edges are approximated, 5-0 nylon sutures will be used to align the epidermal edges in a running fashion, with sutures spaced 3-5mm apart and 2-3 mm from the wound edge. Suturing will begin at the wound poles and run towards the center. The running nylon sutures will be tied off separately for each wound half, which will facilitate suture removal in 1 or 2 weeks. Order of suturing the halves will be at the preference of the surgeon, as randomization will take place later at suture removal. The entire wound will then be dressed with a bandage, which will be left on 24 hours, at which point they may wash the site and change the bandage daily.
The patient will next present at 1 week (7 days) for randomization and suture removal of one half. The half that is either superior or on the patient's right will be labeled "A," and the other half will be labeled "B". This labeling will be photographed into the patient's electronic medical record and will be kept consistent for the remainder of the study. The patient will then be randomized using a random number generator (random.org), generating a number 1 or 2. If randomization yields a 1, then half A is removed first. If randomization yields a 2, then half B is removed first. The patient will return again at 2 weeks for removal of the second half of the nylon sutures.
At two months, patients will have standardized wound photographs taken: the wound will be re-labeled with "A" or "B" as it was at the time of suture removal. A Nikon SLR camera with 105mm macro lens, Wireless speedlight mounted on a ring, aperture F11, shutter 1/250 second, and Iso 64 will be consistent for all photographs. A standard grey background will be used, and the photograph will be taken at 90 degrees to the wound with the full face filling the frame.
The primary outcome will be the Scar Cosmesis Assessment and Rating scale (SCAR) score, with photographic assessment by three blinded fellowship-trained board-certified Mohs surgeons who were not involved with the original surgery or wound repair. There will be a preliminary statistical analysis, and if there is no difference between groups at 2-months, then the study will be ended (prior research has shown that if there is no difference at interim follow up, then the probability of difference at 1-year follow up is low enough as to not justify additional office visits for the patient). If there is a statistical difference seen at 2-months, then the study will continue through a 12-month visit, at which point repeat clinical photographs will be taken and evaluated as above.
- Conditions
- Suture; Complications, Mechanical, Scar, Surgery
- Being tested
- Suture removal timing
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture removal timingProcedure or surgery
Cutaneous nylon suture removal of each half of the split-scar at one and two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Suture removal at 1 week | Experimental | Cutaneous nylon suture removal of half of the split-scar at one week. Receives: Procedure: Suture removal timing |
| Suture removal at 2 weeks | Experimental | Cutaneous nylon suture removal of half of the split-scar at two weeks. Receives: Procedure: Suture removal timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar Cosmesis Assessment and Rating scale (SCAR) score
- Scar Cosmesis Assessment and Rating scale (SCAR), rated by three blinded observers based on digital photographs, with each half of the scar scored separately. This is a 0-13 rating with 0 representing the best possible scar.
Measured: 2months (and possibly one year, see protocol)
Secondary outcomes (6)
pain level with suture removal
0-10 scale
Measured: measured at 1 and 2 weeks after suture removal
difficulty of suture removal
provider ranked difficulty of suture removal (easy, moderate or difficult)
Measured: measured at 1 and 2 weeks
Patient scar satisfaction
patients will rate "how satisfied are you with the scar" on a 0-10 point scale (10= most satisfied) on each half of the wound
Measured: At 2 months
Patient preference for 1 vs 2 week suture removal.
At the 2-month visit patients will be asked whether they prefer 1 week or 2 week suture removal (answer choices will be 1 week/2 week/no preference). If they have a preference, an open-ended question as to why will be asked.
Measured: Asked at 2 months
Presence of suture tracks
Whether or not suture track marks were present at 2 months.
Measured: 2 months
Rates of complications
Rates of complications (dehiscence, infection, hematoma, deep suture reaction) on each half of the wound.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start24 Feb 2022
- Primary completion24 May 2023 (estimated)
- Study completion24 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Suture; Complications, MechanicalStudies 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
- Single group
- Model description
- Split Scar Study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DermSurgery Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonard H Goldberg, MD, Study director, DermSurgery Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267002
- Sponsor's protocol ID
- 9728
- Status last verified
- Feb 2022
- First submitted
- 24 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eisen DB, Zhuang AR, Hasan A, Sharon VR, Bang H, Crispin MK. 5-0 Polypropylene versus 5-0 fast absorbing plain gut for cutaneous wound closure: a randomized evaluator blind trial. Arch Dermatol Res. 2020 Apr;312(3):179-185. doi: 10.1007/s00403-019-02009-5. Epub 2019 Nov 13.
PubMed 31724097Yag-Howard C. Sutures, needles, and tissue adhesives: a review for dermatologic surgery. Dermatol Surg. 2014 Sep;40 Suppl 9:S3-S15. doi: 10.1097/01.DSS.0000452738.23278.2d.
PubMed 25158874Gal P, Toporcer T, Vidinsky B, Hudak R, Zivcak J, Sabo J. Simple interrupted percutaneous suture versus intradermal running suture for wound tensile strength measurement in rats: a technical note. Eur Surg Res. 2009;43(1):61-5. doi: 10.1159/000219214. Epub 2009 May 19.
PubMed 19451720Joo JS, Zhuang AR, Tchanque-Fossuo C, Tartar D, Armstrong AW, King TH, Sivamani RK, Eisen DB. Dermal suture only versus layered closure: A randomized, split wound comparative effectiveness trial. J Am Acad Dermatol. 2019 Dec;81(6):1346-1352. doi: 10.1016/j.jaad.2019.08.040. Epub 2019 Aug 21.
PubMed 31442535Kantor J. Reliability and Photographic Equivalency of the Scar Cosmesis Assessment and Rating (SCAR) Scale, an Outcome Measure for Postoperative Scars. JAMA Dermatol. 2017 Jan 1;153(1):55-60. doi: 10.1001/jamadermatol.2016.3757.
PubMed 27806156
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Week Versus Two Week Removal of Nylon Cutaneous Sutures for Linear Layered Closures on the Face: a Randomized Evaluator-blinded Prospective Split-scar Trial
- ClinicalTrials.gov ID
- NCT05267002
- Acronym / sponsor ID
- 9728
- Conditions
- Suture; Complications, Mechanical, Scar, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- DermSurgery AssociatesUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 24 May 2023 (estimated)
- Study completion
- 24 May 2023 (estimated)
- First posted
- 4 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.
Our goal is to compare the difference in surgical outcomes and patient satisfaction for surgical scars on the face between suture removal at 1 week versus 2 weeks.
There is variation in the timing at which Mohs surgeons remove sutures on the face. Some prefer 1 week, and others prefer 2 weeks. This has not been formally studied. It is possible the outcomes are the same between both groups, or that one has a better cosmetic outcome than the other.
Your skin cancer will be removed as usual. After this, your wound will be sutured in the usual fashion, except the top sutures will be divided into two separate halves. You will return at 1 week for one half of the top sutures to be removed, and at 2 weeks for the other half to be removed. Which half is removed first will be determined at random at your 1 week visit. At two months, you will return for standardized photographs which will be used by physicians to rate the cosmetic outcomes of the wound halves based on a standardized scale. Most likely, there will be no difference between the wound halves at 2 months and the study is complete. There is a small chance that there will be a cosmetic difference seen at 2 months, in which case you will return at 1 year for repeat standardized photographs and ratings. All data and photographs will be kept secure and any identifying information will be destroyed at the end of the study.
Detailed description
This is an investigator initiated, single-center, prospective, randomized, evaluator-blinded split-scar study. Subjects will be recruited at the time of repair for Mohs surgery or excision based on the inclusion criteria above. Procedures will be performed by fellowship trained Mohs surgeons or fellows in training. The same surgeon will close the entire wound. At the time of wound closure, the wound will be divided into two equal halves. Subcutaneous 4-0 or 5-0 polyglecaprone sutures will be used to fully approximate the wound edges. Subcutaneous sutures will begin with one subcutaneous suture immediately in the center of the wound, followed by symmetrical subcutaneous sutures on both sides of the defect until the wound edges are approximated.
Once the wound edges are approximated, 5-0 nylon sutures will be used to align the epidermal edges in a running fashion, with sutures spaced 3-5mm apart and 2-3 mm from the wound edge. Suturing will begin at the wound poles and run towards the center. The running nylon sutures will be tied off separately for each wound half, which will facilitate suture removal in 1 or 2 weeks. Order of suturing the halves will be at the preference of the surgeon, as randomization will take place later at suture removal. The entire wound will then be dressed with a bandage, which will be left on 24 hours, at which point they may wash the site and change the bandage daily.
The patient will next present at 1 week (7 days) for randomization and suture removal of one half. The half that is either superior or on the patient's right will be labeled "A," and the other half will be labeled "B". This labeling will be photographed into the patient's electronic medical record and will be kept consistent for the remainder of the study. The patient will then be randomized using a random number generator (random.org), generating a number 1 or 2. If randomization yields a 1, then half A is removed first. If randomization yields a 2, then half B is removed first. The patient will return again at 2 weeks for removal of the second half of the nylon sutures.
At two months, patients will have standardized wound photographs taken: the wound will be re-labeled with "A" or "B" as it was at the time of suture removal. A Nikon SLR camera with 105mm macro lens, Wireless speedlight mounted on a ring, aperture F11, shutter 1/250 second, and Iso 64 will be consistent for all photographs. A standard grey background will be used, and the photograph will be taken at 90 degrees to the wound with the full face filling the frame.
The primary outcome will be the Scar Cosmesis Assessment and Rating scale (SCAR) score, with photographic assessment by three blinded fellowship-trained board-certified Mohs surgeons who were not involved with the original surgery or wound repair. There will be a preliminary statistical analysis, and if there is no difference between groups at 2-months, then the study will be ended (prior research has shown that if there is no difference at interim follow up, then the probability of difference at 1-year follow up is low enough as to not justify additional office visits for the patient). If there is a statistical difference seen at 2-months, then the study will continue through a 12-month visit, at which point repeat clinical photographs will be taken and evaluated as above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split Scar Study
| Arm | Type | Receives |
|---|---|---|
| Suture removal at 1 week | Experimental | Procedure: Suture removal timingCutaneous nylon suture removal of half of the split-scar at one week. |
| Suture removal at 2 weeks | Experimental | Procedure: Suture removal timingCutaneous nylon suture removal of half of the split-scar at two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Suture removal timingCutaneous nylon suture removal of each half of the split-scar at one and two weeks. | Procedure or surgery | Suture removal at 1 week, Suture removal at 2 weeks |
Primary outcome
Scar Cosmesis Assessment and Rating scale (SCAR) score
Time frame: 2months (and possibly one year, see protocol)
1. Scar Cosmesis Assessment and Rating scale (SCAR), rated by three blinded observers based on digital photographs, with each half of the scar scored separately. This is a 0-13 rating with 0 representing the best possible scar.
6 secondary outcomes
pain level with suture removal
Time frame: measured at 1 and 2 weeks after suture removal
difficulty of suture removal
Time frame: measured at 1 and 2 weeks
Patient scar satisfaction
Time frame: At 2 months
Patient preference for 1 vs 2 week suture removal.
Time frame: Asked at 2 months
Presence of suture tracks
Time frame: 2 months
Rates of complications
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Background: PubMed 31724097Eisen DB, Zhuang AR, Hasan A, Sharon VR, Bang H, Crispin MK. 5-0 Polypropylene versus 5-0 fast absorbing plain gut for cutaneous wound closure: a randomized evaluator blind trial. Arch Dermatol Res. 2020 Apr;312(3):179-185. doi: 10.1007/s00403-019-02009-5. Epub 2019 Nov 13.
- Background: PubMed 25158874Yag-Howard C. Sutures, needles, and tissue adhesives: a review for dermatologic surgery. Dermatol Surg. 2014 Sep;40 Suppl 9:S3-S15. doi: 10.1097/01.DSS.0000452738.23278.2d.
- Background: PubMed 19451720Gal P, Toporcer T, Vidinsky B, Hudak R, Zivcak J, Sabo J. Simple interrupted percutaneous suture versus intradermal running suture for wound tensile strength measurement in rats: a technical note. Eur Surg Res. 2009;43(1):61-5. doi: 10.1159/000219214. Epub 2009 May 19.
- Background: PubMed 31442535Joo JS, Zhuang AR, Tchanque-Fossuo C, Tartar D, Armstrong AW, King TH, Sivamani RK, Eisen DB. Dermal suture only versus layered closure: A randomized, split wound comparative effectiveness trial. J Am Acad Dermatol. 2019 Dec;81(6):1346-1352. doi: 10.1016/j.jaad.2019.08.040. Epub 2019 Aug 21.
- Background: PubMed 27806156Kantor J. Reliability and Photographic Equivalency of the Scar Cosmesis Assessment and Rating (SCAR) Scale, an Outcome Measure for Postoperative Scars. JAMA Dermatol. 2017 Jan 1;153(1):55-60. doi: 10.1001/jamadermatol.2016.3757.
- 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.
Leonard H Goldberg, MD study director
DermSurgery Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture removal timing in people with Suture; Complications, Mechanical and Scar, run by DermSurgery Associates at 1 site 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?
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: status not confirmed, as of the sponsor's last update on 4 Mar 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Remi Hamel, MD (713.791.9966, mariam@dermsurgery.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar Cosmesis Assessment and Rating scale (SCAR) score (time frame: 2months (and possibly one year, see protocol)). 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 NCT05267002, which also lists 5 linked publications.
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 4 Mar 2022.