Surgical WoundNCT03425370
Effect of Replacing Buried Sutures With Tissue Adhesive on Aesthetic Outcome of Surgical Wounds.
A study testing Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome. in people with Surgical Wound, run by West Virginia University at 1 site in United States.
Trial summary
Surgery wounds are typically closed with combination of absorbable stitches placed under the skin and non-absorbable stitched placed at the skin surface. Absorbable sutures can produce unwanted side effects when the body produces a reaction to them. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound
- What is being tested?
- Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2018to 31 Oct 2018
- 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
Who may be able to join
- Age 18 years or older
- Postoperative defects of at least 3 cm, resulting from either Mohs micrographic surgery or surgical excision
- Willing to give informed consent and return for follow-up visits 3 months and 6 months following surgery
Who cannot join
- Pregnant
- Unable to understand English
- Mentally impaired
- Incarcerated
- Has nonlinear closures
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University University Town Centre Dermatology Clinic
Morgantown, West Virginia, 26501
About this study
Surgery wounds are typically closed with combination of absorbable stitches placed under the skin and non-absorbable stitched placed at the skin surface. Absorbable sutures can produce unwanted side effects when the body produces a reaction to them. The investigators are conducting a study to determine if absorbable stitches can be replaced but tissue glue applied on the surface of the skin. If participants enroll in the study, the investigators will close one half of the participants wound with absorbable stitches placed under the skin and non-absorbable stitches on the surface. The other half of the wound will be closed with non-absorbable stitches and tissue glue. The appearance of the scar (if any) will then be evaluated at 3- and 6-month follow-ups by two dermatologists (either board-certified dermatologists or dermatology residents) and the patient.
- Conditions
- Surgical Wound
- Being tested
- Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.
- Keywords
- Surgical wounds, Tissue adhesive, Sutures, Wound healing
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.Procedure or surgery
Effect of replacing buried sutures with tissue adhesive on aesthetic outcome of surgical wounds will be measured using the POSAS.
| Study group | Role | What they receive |
|---|---|---|
| Wound Side A: buried sutures, Wound Side B: tissue adhesive | Experimental | Wounds halves will be labeled as A (left/superior) or B (right/inferior), the halves will be randomized to receive either tissue glue or deep sutures. Receives: Procedure: Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome. |
| Wound Side A: tissue adhesive, Wound Side B: buried sutures | Experimental | Wounds halves will be labeled as A (left/superior) or B (right/inferior), the halves will be randomized to receive either tissue glue or deep sutures. Receives: Procedure: Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rating the healing progression of the wound
By observation using the Patient-Observer Scar Assessment Scale (POSAS)
Measured: 3 months after surgical wound closure
Rating the healing progression of the wound
By observation using the Patient-Observer Scar Assessment Scale (POSAS)
Measured: 6 months after surgical wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start26 Jan 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Why it stopped: Wound dehiscence on tissue adhesive side of 1 wound which developed an infection.
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 West Virginia 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Wounds halves will be labeled as A (left/superior) or B (right/inferior), the halves will be randomized to receive either tissue glue or deep sutures. The nurse will refer to the randomization list and inform the surgeon which side of the wound will receive tissue glue and which side will receive deep sutures. Following common practice of wound labeling, side A will always be left or superior from the surgeon's perspective, whereas side B will always be right or inferior from the surgeon's perspective. Per randomization, half of the wound will be closed with deep absorbable sutures followed by superficial non-absorbable sutures. The other half of the wound will be closed with superficial non-absorbable sutures followed by tissue glue (Dermabond). Tissue glue will be spread to cover an area extending one cm from the wound margin on both sides.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Kolodney, West Virginia University
- Investigators
- Michael S Kolodney, MD, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425370
- Sponsor's protocol ID
- 1710792979
- Status last verified
- Oct 2018
- First submitted
- 25 Jan 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Replacing Buried Sutures With Tissue Adhesive on Aesthetic Outcome of Surgical Wounds.
- ClinicalTrials.gov ID
- NCT03425370
- Acronym / sponsor ID
- 1710792979
- Conditions
- Surgical Wound
- Keywords
- Surgical wounds, Tissue adhesive, Sutures, Wound healing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Wound dehiscence on tissue adhesive side of 1 wound which developed an infection.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 7 Feb 2018 (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.
Surgery wounds are typically closed with combination of absorbable stitches placed under the skin and non-absorbable stitched placed at the skin surface. Absorbable sutures can produce unwanted side effects when the body produces a reaction to them. The investigators are conducting a study to determine if absorbable stitches can be replaced but tissue glue applied on the surface of the skin. If participants enroll in the study, the investigators will close one half of the participants wound with absorbable stitches placed under the skin and non-absorbable stitches on the surface. The other half of the wound will be closed with non-absorbable stitches and tissue glue. The appearance of the scar (if any) will then be evaluated at 3- and 6-month follow-ups by two dermatologists (either board-certified dermatologists or dermatology residents) and the patient.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Wounds halves will be labeled as A (left/superior) or B (right/inferior), the halves will be randomized to receive either tissue glue or deep sutures. The nurse will refer to the randomization list and inform the surgeon which side of the wound will receive tissue glue and which side will receive deep sutures. Following common practice of wound labeling, side A will always be left or superior from the surgeon's perspective, whereas side B will always be right or inferior from the surgeon's perspective. Per randomization, half of the wound will be closed with deep absorbable sutures followed by superficial non-absorbable sutures. The other half of the wound will be closed with superficial non-absorbable sutures followed by tissue glue (Dermabond). Tissue glue will be spread to cover an area extending one cm from the wound margin on both sides.
| Arm | Type | Receives |
|---|---|---|
| Wound Side A: buried sutures, Wound Side B: tissue adhesive | Experimental | Procedure: Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.Wounds halves will be labeled as A (left/superior) or B (right/inferior), the halves will be randomized to receive either tissue glue or deep sutures. |
| Wound Side A: tissue adhesive, Wound Side B: buried sutures | Experimental | Procedure: Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.Wounds halves will be labeled as A (left/superior) or B (right/inferior), the halves will be randomized to receive either tissue glue or deep sutures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Postoperative defects of at least 3 cm, resulting from either Mohs micrographic surgery or surgical excision
- Willing to give informed consent and return for follow-up visits 3 months and 6 months following surgery
Key exclusion criteria (5 listed)
- Pregnant
- Unable to understand English
- Mentally impaired
- Incarcerated
- Has nonlinear closures
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 |
|---|---|---|
| Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.Effect of replacing buried sutures with tissue adhesive on aesthetic outcome of surgical wounds will be measured using the POSAS. | Procedure or surgery | Wound Side A: buried sutures, Wound Side B: tissue adhesive, Wound Side A: tissue adhesive, Wound Side B: buried sutures |
Primary outcome
Rating the healing progression of the wound
Time frame: 3 months after surgical wound closure
By observation using the Patient-Observer Scar Assessment Scale (POSAS)
Rating the healing progression of the wound
Time frame: 6 months after surgical wound closure
By observation using the Patient-Observer Scar Assessment Scale (POSAS)
Results and safety
The study was stopped early (reason given: Wound dehiscence on tissue adhesive side of 1 wound which developed an infection.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Surgical Wound
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Not yet recruitingPhase 3
Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:
Next Generation Sequencing (NGS), Surgical Site Infection (SSI)
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
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.
Michael S Kolodney, MD, PhD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome. in people with Surgical Wound, run by West Virginia University 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?
The sponsor lists 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 2 Nov 2018. 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?
The study was stopped early (reason given: Wound dehiscence on tissue adhesive side of 1 wound which developed an infection.). Results are not available in the source record.
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?
Rating the healing progression of the wound (time frame: 3 months after surgical wound closure). The study lists 2 primary outcomes in all. 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 2 Nov 2018; AzTrials last refreshed its copy on 7 Nov 2026.