Wound Vac Polypropylene Suture Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/15/2018 |
| Start Date: | June 2016 |
| End Date: | September 11, 2018 |
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.
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.
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.
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.
Inclusion Criteria:
1. Male or female, age 18 years or older
2. All patients with an open wound who require NPWT
3. Hospitalized patient in need of NPWT for ≥ 6 days
4. Willingness to comply with protocol, complete study assessments (pain scale ratings),
allow pictures to be taken, and provide written informed consent
Exclusion Criteria:
1. Male or female less than 18 years of age
2. Prisoners
3. Outpatients
4. Patients with infected wounds
5. Patients with poor blood flow
6. Hospitalized patient in need of NPWT for < 6 days
7. 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.
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