Wound Vac Polypropylene Suture Pilot Study

NCT02929238 | Completed

• 1 other identifier: pro00049555
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Wound Vac; Suture

Outcome Measures

Primary Outcomes (1)

• Pain Rating Questionnaire

  testing to see if suture decreases the pain when removing the wound vac

  no longer than 6 months

Secondary Outcomes (1)

• Blinded Physician Interpretation

  no longer than 6 months

Study Arms (2)

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.

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.

Other: Polypropylene Suture Left Side

Interventions

Polypropylene Suture Right Side OTHER

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 Right Side

Polypropylene Suture Left Side OTHER

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 Side

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Greenville Health System

Greenville, South Carolina, 29605, United States

Location

Study Officials

• John Cull, M.D.

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2016
• First Posted: October 11, 2016
• Study Start: June 1, 2016
• Primary Completion: September 11, 2018
• Study Completion: September 11, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

US (1)