Wound VacNCT02929238
Wound Vac Polypropylene Suture Pilot Study
A study testing Polypropylene Suture Right Side and Polypropylene Suture Left Side in people with Wound Vac and Suture, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
You are being asked to participate in this study because you have a complex wound that requires treatment with negative pressure wound therapy (NPWT). NPWT is a therapeutic technique which involves the placement of a wound vacuum at the site of the wound. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Polypropylene Suture Right Side and Polypropylene Suture Left Side
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 11 Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18 years or older
- All patients with an open wound who require NPWT
- Hospitalized patient in need of NPWT for ≥ 6 days
- Willingness to comply with protocol, complete study assessments (pain scale ratings), allow pictures to be taken, and provide written informed consent
Who cannot join
- Male or female less than 18 years of age
- Prisoners
- Outpatients
- Patients with infected wounds
- Patients with poor blood flow
- Hospitalized patient in need of NPWT for < 6 days
- Not willing to provide written informed consent or remain in compliance with the study protocol requirements
- Prisoners will be excluded from this study as they are considered an at risk population.
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Health System
Greenville, South Carolina, 29605
About this study
Official title: Polypropylene Suture Interfaced Between Wound and Negative Pressure Wound Therapy to Reduce Pain: a Pilot Study
You are being asked to participate in this study because you have a complex wound that requires treatment with negative pressure wound therapy (NPWT). NPWT is a therapeutic technique which involves the placement of a wound vacuum at the site of the wound. The wound vacuum delivers a negative pressure at the wound site through a dressing. Any fluid collected during this process is collected through a foam (sponge) underneath the dressing. This therapy helps to draw the edges of the wound together, while removing infectious material, to help promote healthy tissue growth and speed up wound healing. The purpose of this study is to determine if placing polypropylene suture (a material normally used to close wounds) between the wound and the NPWT foam would decrease pain upon removal of the sponge while allowing adequate healing of the wound.
Read the detailed description
If you decide to participate in the study you will be asked to sign this informed consent form prior to beginning any study activities. If you agree to participate the study procedures are as follows:
- The participants enrolled in this study will receive NPWT in combination with polypropylene suture being laid out over half of the wound. Enrollment in this study is not considered standard of care.
- You will be randomized (like flipping a coin) to what side of the wound the suture will be placed on. Randomization means the study team has no say in what side the suture goes on. Your information is put into a computer and the computer picks what side to place the suture. The polypropylene suture will be placed over half of your wound. There is an equal chance for the polypropylene suture to be placed on the right or left side. The other half of your wound will not have the polypropylene suture in place and will act as the control (comparison) group in this study. The use of the study polypropylene suture is not considered standard of care.
- The wound vacuum will be placed over the entire wound and will be left in place for no more than 3 days as per standard of care.
- After no more than 3 days at a time during the healing process, the nurses will remove the wound vacuum, dressings, suture, and the sponge.
- One blinded (they are not told which side of the wound the suture is placed on) study physician will come look at your wound. This study physicians will determine if further NPWT, with or without the study polypropylene suture, is needed.
- You will be asked to complete a pain rating questionnaire (rating scale 0-10) in relation to both sides of your wound when the wound vacuum has been removed.
- If further NPWT is needed without the use of the study polypropylene suture, you will be withdrawn from the study
- If discharged with NPWT you will not continue receive polypropylene suture placement and that would be end of study participation
- If further NPWT is needed with the use of negative pressure wound therapy, the polypropylene suture and the sponge will be placed and the process will continue as noted above until your wound is healed or you are withdrawn from the study.
- Information from your medical records will be collected throughout this study. You will also be asked questions about your medical and surgical history as well as what medications you are currently taking.
- Your demographics will be collected including your age, date of birth, race, sex, height, weight, and ethnicity.
- Being tested
- Polypropylene Suture Right Side, Polypropylene Suture Left Side
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polypropylene Suture Right SideOther
Suture Description: The suture used in this study will be a sterilized polypropylene suture and individually crossed in the base of the wound. Polypropylene is commonly used for commercially available implanted meshes. The polypropylene suture is intended for single use only and the individual suture will be packaged and purchased sterile.
Polypropylene Suture Left SideOther
Suture Description: The suture used in this study will be a sterilized polypropylene suture and individually crossed in the base of the wound. Polypropylene is commonly used for commercially available implanted meshes. The polypropylene suture is intended for single use only and the individual suture will be packaged and purchased sterile.
| Study group | Role | What they receive |
|---|---|---|
| Polypropylene Suture Right Side | Experimental | Polypropylene suture will be placed over half the wound. There is an equal chance for the suture to be placed on the right or left through randomization. THe other half of the wound will not have the suture placed on it and will act as the control. The wound vac will be placed over entire wound. Receives: Other: Polypropylene Suture Right Side |
| Polypropylene Suture Left Side | Experimental | Polypropylene suture will be placed over half the wound. There is an equal chance for the suture to be placed on the right or left through randomization. THe other half of the wound will not have the suture placed on it and will act as the control. The wound vac will be placed over entire wound. Receives: Other: Polypropylene Suture Left Side |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Rating Questionnaire
testing to see if suture decreases the pain when removing the wound vac
Measured: no longer than 6 months
Secondary outcomes (1)
Blinded Physician Interpretation
one blinded physician looks at wound to make sure the suture is not interfering with wound healing
Measured: no longer than 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startJun 2016
- Primary completion11 Sep 2018
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound VacStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Cull, M.D., Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929238
- Sponsor's protocol ID
- pro00049555
- Status last verified
- Sep 2018
- First submitted
- 7 Oct 2016
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polypropylene Suture Interfaced Between Wound and Negative Pressure Wound Therapy to Reduce Pain: a Pilot Study
- ClinicalTrials.gov ID
- NCT02929238
- Acronym / sponsor ID
- pro00049555
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 11 Oct 2016 (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.
You are being asked to participate in this study because you have a complex wound that requires treatment with negative pressure wound therapy (NPWT). NPWT is a therapeutic technique which involves the placement of a wound vacuum at the site of the wound. The wound vacuum delivers a negative pressure at the wound site through a dressing. Any fluid collected during this process is collected through a foam (sponge) underneath the dressing. This therapy helps to draw the edges of the wound together, while removing infectious material, to help promote healthy tissue growth and speed up wound healing. The purpose of this study is to determine if placing polypropylene suture (a material normally used to close wounds) between the wound and the NPWT foam would decrease pain upon removal of the sponge while allowing adequate healing of the wound.
Detailed description
If you decide to participate in the study you will be asked to sign this informed consent form prior to beginning any study activities. If you agree to participate the study procedures are as follows:
- The participants enrolled in this study will receive NPWT in combination with polypropylene suture being laid out over half of the wound. Enrollment in this study is not considered standard of care.
- You will be randomized (like flipping a coin) to what side of the wound the suture will be placed on. Randomization means the study team has no say in what side the suture goes on. Your information is put into a computer and the computer picks what side to place the suture. The polypropylene suture will be placed over half of your wound. There is an equal chance for the polypropylene suture to be placed on the right or left side. The other half of your wound will not have the polypropylene suture in place and will act as the control (comparison) group in this study. The use of the study polypropylene suture is not considered standard of care.
- The wound vacuum will be placed over the entire wound and will be left in place for no more than 3 days as per standard of care.
- After no more than 3 days at a time during the healing process, the nurses will remove the wound vacuum, dressings, suture, and the sponge.
- One blinded (they are not told which side of the wound the suture is placed on) study physician will come look at your wound. This study physicians will determine if further NPWT, with or without the study polypropylene suture, is needed.
- You will be asked to complete a pain rating questionnaire (rating scale 0-10) in relation to both sides of your wound when the wound vacuum has been removed.
- If further NPWT is needed without the use of the study polypropylene suture, you will be withdrawn from the study
- If discharged with NPWT you will not continue receive polypropylene suture placement and that would be end of study participation
- If further NPWT is needed with the use of negative pressure wound therapy, the polypropylene suture and the sponge will be placed and the process will continue as noted above until your wound is healed or you are withdrawn from the study.
- Information from your medical records will be collected throughout this study. You will also be asked questions about your medical and surgical history as well as what medications you are currently taking.
- Your demographics will be collected including your age, date of birth, race, sex, height, weight, and ethnicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polypropylene Suture Right Side | Experimental | Other: Polypropylene Suture Right SidePolypropylene suture will be placed over half the wound. There is an equal chance for the suture to be placed on the right or left through randomization. THe other half of the wound will not have the suture placed on it and will act as the control. The wound vac will be placed over entire wound. |
| Polypropylene Suture Left Side | Experimental | Other: Polypropylene Suture Left SidePolypropylene suture will be placed over half the wound. There is an equal chance for the suture to be placed on the right or left through randomization. THe other half of the wound will not have the suture placed on it and will act as the control. The wound vac will be placed over entire wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, age 18 years or older
- All patients with an open wound who require NPWT
- Hospitalized patient in need of NPWT for ≥ 6 days
- Willingness to comply with protocol, complete study assessments (pain scale ratings), allow pictures to be taken, and provide written informed consent
Key exclusion criteria (8 listed)
- Male or female less than 18 years of age
- Prisoners
- Outpatients
- Patients with infected wounds
- Patients with poor blood flow
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 |
|---|---|---|
| Polypropylene Suture Right SideSuture Description: The suture used in this study will be a sterilized polypropylene suture and individually crossed in the base of the wound. Polypropylene is commonly used for commercially available implanted meshes. The polypropylene suture is intended for single use only and the individual suture will be packaged and purchased sterile. | Other | Polypropylene Suture Right Side |
| Polypropylene Suture Left SideSuture Description: The suture used in this study will be a sterilized polypropylene suture and individually crossed in the base of the wound. Polypropylene is commonly used for commercially available implanted meshes. The polypropylene suture is intended for single use only and the individual suture will be packaged and purchased sterile. | Other | Polypropylene Suture Left Side |
Primary outcome
Pain Rating Questionnaire
Time frame: no longer than 6 months
testing to see if suture decreases the pain when removing the wound vac
1 secondary outcome
Blinded Physician Interpretation
Time frame: no longer than 6 months
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 13 Sep 2018.
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.
John Cull, M.D. principal investigator
Prisma Health-Upstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polypropylene Suture Right Side and Polypropylene Suture Left Side in people with Wound Vac and Suture, run by Prisma Health-Upstate 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 4 inclusion and 8 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 13 Sep 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 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?
Pain Rating Questionnaire (time frame: no longer than 6 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 13 Sep 2018; AzTrials last refreshed its copy on 28 Oct 2026.