Pain, PostoperativeNCT01313754
Comparison of Skin Incision Closure Material for the Transobturator Suburethral Sling Procedure
A study testing Vicryl Suture and Dermabond in people with Pain, Postoperative and Irritation (Physical), run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study is to compare different skin closure materials for the transobturator suburethral sling procedure. Currently the investigators are using monocryl suture material as the standard for skin closure. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative, Irritation (Physical), Pelvic Pain
- What is being tested?
- Vicryl Suture and Dermabond
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2012
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those patients receiving a transobturator suburethral sling procedure.
- Adults (>= 18years).
Who cannot join
- Non-English speaking.
- Allergy to monocryl, vicryl, or dermabond.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
The purpose of this study is to compare different skin closure materials for the transobturator suburethral sling procedure. Currently the investigators are using monocryl suture material as the standard for skin closure. This material has anecdotally show to be very irritating to patients who have had this type of surgery. Our study will compare the monocryl suture material with vicryl (polyglactin 910) and dermabond (2-octyl cyanoacrylate) skin glue. The investigators believe that vicryl suture material will be superior in comfort when compared to monocryl and dermabond for this type of procedure.
- Conditions
- Pain, Postoperative, Irritation (Physical), Pelvic Pain
- Being tested
- Vicryl Suture, Dermabond
- Keywords
- Skin closure, dermabond, vicryl, monocryl, Suburethral sling, Transobturator Sling, Pain, Discomfort, Skin irritation
- Medical subject headings
- Pain, Postoperative, Pelvic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicryl SutureProcedure or surgery
Also called polyglactin 910
Vicryl suture material will be placed on the patients left sided incision.
DermabondProcedure or surgery
Also called 2-octyl cyanoacrylate
Dermabond skin glue will be placed on the patients left sided incision.
| Study group | Role | What they receive |
|---|---|---|
| Vicryl | Other | These patients will receive the standard monocryl suture on their right sided inguinal incision and then will receive the vicryl material on the left. Receives: Procedure: Vicryl Suture |
| Dermabond | Experimental | The patients will receive the standard monocryl suture on their right sided inguinal incision and then will receive dermabond skin glue on the left Receives: Procedure: Dermabond |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of severity of patient discomfort at their incision sites.
Measured: The patients will be assessed at their second week post operative visit.
Secondary outcomes (1)
Cosmesis at the incision sites
Measured: The patients will be assessed at their 2nd week post operative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Loma Linda 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Waggonner, MD, Loma Linda University
- Investigators
- Sam Siddighi, M.D., Principal investigatorDavid B Waggonner, M.D., Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313754
- Sponsor's protocol ID
- DWSS-01
- Status last verified
- Jan 2013
- First submitted
- 10 Mar 2011
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Skin Incision Closure Material for the Transobturator Suburethral Sling Procedure
- ClinicalTrials.gov ID
- NCT01313754
- Acronym / sponsor ID
- DWSS-01
- Conditions
- Pain, Postoperative, Irritation (Physical), Pelvic Pain
- Keywords
- Skin closure, dermabond, vicryl, monocryl, Suburethral sling, Transobturator Sling, Pain, Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Mar 2011 (estimated)
- 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.
The purpose of this study is to compare different skin closure materials for the transobturator suburethral sling procedure. Currently the investigators are using monocryl suture material as the standard for skin closure. This material has anecdotally show to be very irritating to patients who have had this type of surgery. Our study will compare the monocryl suture material with vicryl (polyglactin 910) and dermabond (2-octyl cyanoacrylate) skin glue. The investigators believe that vicryl suture material will be superior in comfort when compared to monocryl and dermabond for this type of procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vicryl | Other | Procedure: Vicryl SutureThese patients will receive the standard monocryl suture on their right sided inguinal incision and then will receive the vicryl material on the left. |
| Dermabond | Experimental | Procedure: DermabondThe patients will receive the standard monocryl suture on their right sided inguinal incision and then will receive dermabond skin glue on the left |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Those patients receiving a transobturator suburethral sling procedure.
- Adults (>= 18years).
Key exclusion criteria (2 listed)
- Non-English speaking.
- Allergy to monocryl, vicryl, or dermabond.
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 |
|---|---|---|
| Vicryl SutureAlso: polyglactin 910Vicryl suture material will be placed on the patients left sided incision. | Procedure or surgery | Vicryl |
| DermabondAlso: 2-octyl cyanoacrylateDermabond skin glue will be placed on the patients left sided incision. | Procedure or surgery | Dermabond |
Primary outcome
The level of severity of patient discomfort at their incision sites.
Time frame: The patients will be assessed at their second week post operative visit.
1 secondary outcome
Cosmesis at the incision sites
Time frame: The patients will be assessed at their 2nd week post operative visit
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 31 Jan 2013.
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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.
Sam Siddighi, M.D. principal investigator
David B Waggonner, M.D. study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vicryl Suture and Dermabond in people with Pain, Postoperative and Irritation (Physical), run by Loma Linda 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 2 inclusion and 2 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 31 Jan 2013. 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 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?
The level of severity of patient discomfort at their incision sites. (time frame: The patients will be assessed at their second week post operative visit.). 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 31 Jan 2013.