Neuralgia, PerinealPALSNCT02055794
Promoting Optimal Healing After Laceration Repair Study
A study testing Suturing of the perineal skin, Closing perineal skin with surgical glue and No suturing of the perineal skin in people with Neuralgia, Perineal, run by University of Michigan at 1 site in United States.
Trial summary
The goal of this research is to investigate three different methods of perineal skin closure during second-degree perineal wound repair and determine which method is associated with the least amount of patient pain. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neuralgia, Perineal
- What is being tested?
- Suturing of the perineal skin, Closing perineal skin with surgical glue and No suturing of the perineal skin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Sep 2017
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 18 years old - 45 years old
- Immediately post-vaginal birth, including forceps-assisted vaginal delivery, vacuum-assisted vaginal delivery
- > 32 weeks gestation
- Second degree laceration from spontaneous tear or midline episiotomy
- Proficient in English
Who cannot join
- <18 years old and >45 years old
- Delivery by Cesarean
- 1st, 3rd or 4th degree lacerations
- Induction for intrauterine fetal demise or terminal fetal condition, or any instance where immediate status of the newborn is unknown
- Known allergy to cyanoacrylate or formaldehyde
- Systemic infections, uncontrolled diabetes (women with well-controlled pre-gestational or gestational diabetes will not be excluded)
Show all 13Show fewer
- History of connective tissue disorders (e.g. Scleroderma, Ehlers Danlos)
- Chronic use of steroids
- Currently under treatment for cancer
- Previous radiation to the pelvis
- Any organ transplants
- History of neurological conditions including multiple sclerosis, stroke, Alzheimer's, or other dementias
- Not proficient in the English language
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Promoting Optimal Healing After Laceration Repair Study - PALS Study
The goal of this research is to investigate three different methods of perineal skin closure during second-degree perineal wound repair and determine which method is associated with the least amount of patient pain.
Null hypothesis: There will be no difference in patient pain among the three different methods for second degree perineal wound repair.
Read the detailed description
At the University of Michigan, there are currently two standard techniques for repairing second-degree perineal lacerations that differ only in management of the perineal skin :
- Closure of the deep tissues and superficial perineal skin using a continuous 3-0 Vicryl suture
- Closure of the deep tissues with a continuous 3-0 Vicryl suture and reapproximation of, but not suture-closure of the perineal skin.
The primary goal of our study is to compare patient pain amongst the following three perineal skin repair techniques after second degree laceration:
- Perineal skin closure with suturing
- Not suturing the perineal skin
- Closure of the perineal skin with n-Butyl 2-cyanoacrylate (Indermil®) surgical glue.
In all women, the deep vaginal and perineal tissues will be closed using a continuous 3-0 Vicryl suture, as is current standard practice.
Aim: To assess and compare patient pain among the three groups at intervals of 1 day, 2 weeks, 6 weeks and 3 months postpartum.
- Conditions
- Neuralgia, Perineal
- Being tested
- Suturing of the perineal skin, Closing perineal skin with surgical glue, No suturing of the perineal skin
- Keywords
- perineal wound, perineal tear, perineum, pain, childbirth
- Medical subject headings
- Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suturing of the perineal skinProcedure or surgery
Closing perineal skin with surgical glueProcedure or surgery
Also called n-Butyl 2-cyanoacrylate, Indermil®, surgical glue
No suturing of the perineal skinProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Suturing of the perineal skin | Active comparator | Suturing of the perineal skin after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture. Receives: Procedure: Suturing of the perineal skin |
| No suturing of the perineal skin | Active comparator | No suturing of the perineal skin after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture. Receives: Procedure: No suturing of the perineal skin |
| Closing perineal skin with surgical glue | Active comparator | Closure of the perineal skin with n-Butyl 2-cyanoacrylate (Indermil®) surgical glue after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture. Receives: Procedure: Closing perineal skin with surgical glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-perceived pain
The 2 week and 3 month measurements will be done via email, web or mailed questionnaire. Pain will be measured using 3 pain scales: a validated 100-mm Visual Analogue Scale (VAS) (anchors: 0 = none, 100 mm = worst imaginable), a 6 point Likert scale and the McGill pain questionnaire short form.
Measured: Post-partum (PPD), 2 weeks, 6 weeks and 3 months.
Secondary outcomes (1)
Wound assessment
Wounds will be assessed through wound evaluation (6 weeks post-partum), wound complications (wound infection, dehiscence, granulation tissue), need for additional interventions (silver nitrate, revision of wound) and assessment of wound appearance using a validated 100-mm VAS (anchors: 0 = worst scar, 100 mm = best scar).
Measured: 6 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuralgia, PerinealStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dee Fenner, University of Michigan
- Investigators
- Dee Fenner, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055794
- Sponsor's protocol ID
- HUM00079230
- Acronym
- PALS
- Status last verified
- Oct 2017
- First submitted
- 4 Feb 2014
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Optimal Healing After Laceration Repair Study - PALS Study
- ClinicalTrials.gov ID
- NCT02055794
- Acronym / sponsor ID
- PALS / HUM00079230
- Conditions
- Neuralgia, Perineal
- Keywords
- perineal wound, perineal tear, perineum, pain, childbirth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 5 Feb 2014 (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 goal of this research is to investigate three different methods of perineal skin closure during second-degree perineal wound repair and determine which method is associated with the least amount of patient pain.
Null hypothesis: There will be no difference in patient pain among the three different methods for second degree perineal wound repair.
Detailed description
At the University of Michigan, there are currently two standard techniques for repairing second-degree perineal lacerations that differ only in management of the perineal skin :
- Closure of the deep tissues and superficial perineal skin using a continuous 3-0 Vicryl suture
- Closure of the deep tissues with a continuous 3-0 Vicryl suture and reapproximation of, but not suture-closure of the perineal skin.
The primary goal of our study is to compare patient pain amongst the following three perineal skin repair techniques after second degree laceration:
- Perineal skin closure with suturing
- Not suturing the perineal skin
- Closure of the perineal skin with n-Butyl 2-cyanoacrylate (Indermil®) surgical glue.
In all women, the deep vaginal and perineal tissues will be closed using a continuous 3-0 Vicryl suture, as is current standard practice.
Aim: To assess and compare patient pain among the three groups at intervals of 1 day, 2 weeks, 6 weeks and 3 months postpartum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Suturing of the perineal skin | Active comparator | Procedure: Suturing of the perineal skinSuturing of the perineal skin after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture. |
| No suturing of the perineal skin | Active comparator | Procedure: No suturing of the perineal skinNo suturing of the perineal skin after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture. |
| Closing perineal skin with surgical glue | Active comparator | Procedure: Closing perineal skin with surgical glueClosure of the perineal skin with n-Butyl 2-cyanoacrylate (Indermil®) surgical glue after deep vaginal and perineal tissues are closed using a continuous 3-0 Vicryl suture. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women 18 years old - 45 years old
- Immediately post-vaginal birth, including forceps-assisted vaginal delivery, vacuum-assisted vaginal delivery
- > 32 weeks gestation
- Second degree laceration from spontaneous tear or midline episiotomy
- Proficient in English
Key exclusion criteria (13 listed)
- <18 years old and >45 years old
- Delivery by Cesarean
- 1st, 3rd or 4th degree lacerations
- Induction for intrauterine fetal demise or terminal fetal condition, or any instance where immediate status of the newborn is unknown
- Known allergy to cyanoacrylate or formaldehyde
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 |
|---|---|---|
| Suturing of the perineal skin | Procedure or surgery | Suturing of the perineal skin |
| Closing perineal skin with surgical glueAlso: n-Butyl 2-cyanoacrylate, Indermil®, surgical glue | Procedure or surgery | Closing perineal skin with surgical glue |
| No suturing of the perineal skin | Procedure or surgery | No suturing of the perineal skin |
Primary outcome
Patient-perceived pain
Time frame: Post-partum (PPD), 2 weeks, 6 weeks and 3 months.
The 2 week and 3 month measurements will be done via email, web or mailed questionnaire. Pain will be measured using 3 pain scales: a validated 100-mm Visual Analogue Scale (VAS) (anchors: 0 = none, 100 mm = worst imaginable), a 6 point Likert scale and the McGill pain questionnaire short form.
1 secondary outcome
Wound assessment
Time frame: 6 weeks post-partum
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 5 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Neuralgia, Perineal
Active, not recruiting
Pudendal Nerve Block With Articaine and Triamcinolone for Pudendal Neuralgia
Pudendal Neuralgia Pudendal Nerve Entrapment Chronic Pelvic Pain
Not yet recruiting
Evolution of Different Sensitivity Levels in Patients With Chronic Neuropathic Pain in the Pelvi-perineal Region After Treatment With High-concentration Capsaicin Patches
Neuropathic Pain, Nociplastic Pain
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.
Dee Fenner, M.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suturing of the perineal skin, Closing perineal skin with surgical glue and No suturing of the perineal skin in people with Neuralgia, Perineal, run by University of Michigan 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 5 inclusion and 13 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 5 Oct 2017. 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?
Patient-perceived pain (time frame: Post-partum (PPD), 2 weeks, 6 weeks and 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 5 Oct 2017.