NCT03701152

Brief Summary

Negative Pressure Wound Therapy (NPWT), is a non invasive wound management tool which develops from negative pressure being applied to the wound. This promotes healing through the removal of infectious materials and enhancing granulation tissue formation. NPWT eases debridement as well as promoting healing of different types of wounds.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

October 7, 2018

Last Update Submit

October 7, 2018

Conditions

Chronic UlcersNegative Pressure Therapy

Outcome Measures

Primary Outcomes (2)

  • Wound surface area

    8 weeks

  • Wound size

    8 weeks

Study Arms (2)

Negative pressure therapy

EXPERIMENTAL

Negative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Continuous course

Device: Negative pressure therapy

Investigator

EXPERIMENTAL

Negative pressure therapy topical application using negative pressure therapy sub atmospheric pressure Splitted course

Device: Negative pressure therapy

Interventions

Negative pressure therapyDEVICE

Negative pressure therapy at sub atmospheric level

InvestigatorNegative pressure therapy

Eligibility Criteria

Age27 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • They were free from immune deficiency diseases or collagen diseases.
  • All patients were homeostasis.
  • All patients were medically stable.
  • All cases were chronic and did not heal with other treatment methods

You may not qualify if:

  • \. Malignancies or receiving radiotherapy. 2. Dermatological diseases. 3. Deep venous thrombosis. 4. Renal failure. 5. Immunosuppressant or anticonvulsants therapies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banha University

Banhā, 456155, Egypt

RECRUITING

Related Publications (1)

  • Mohammed AH, Hamed SA, Abdelghany AI. Comparison between two different protocols of negative pressure therapy for healing of chronic ulcers. J Tissue Viability. 2020 Feb;29(1):37-41. doi: 10.1016/j.jtv.2019.10.003. Epub 2019 Oct 25.

    PMID: 31677995DERIVED

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Central Study Contacts

Ashraf Hassan, phD

CONTACT

+2001067302580ashraf.hassan@buc.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 7, 2018

First Posted

October 9, 2018

Study Start

January 1, 2018

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

EG(1)