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Comparison between negative pressure fixation and film dressing in wound management after tissue expansion. A prospective, open-label, randomized, single-center study.

Comparison between negative pressure fixation and film dressing in wound management after tissue expansion. A prospective, open-label, randomized, single-center study. - Comparison between negative pressure fixation and film dressing in wound management

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014424
Enrollment
20
Registered
2014-07-03
Start date
2014-07-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who wish to breast reconstruction

Interventions

Each form of NPF and FD is used to a half of sutured wound.

Sponsors

Plastic and reconstructive surgery, Hamamatsu university school of medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: The patients that undergo tissue expander insertion surgery at the same time as the mastectomy. Patients that gave voluntary consent to participate in this study. The patients (aged from 18 to 65 years old) were eligible for participation.

Exclusion criteria

Exclusion criteria: 1.Patients that do not give consent 2.Patients that have been subjected to the post-operative irradiation 3.Patients with adverse reaction to adhesive skin patch 4.Patients that suffer from the local infection or wound dehiscence at the study initiation 5.Patients that underwent replacement of the implant within six months after the first surgery 6.Patients that the doctor judged ineligible for the study

Design outcomes

Primary

MeasureTime frame
VAS score

Secondary

MeasureTime frame
The area of the scar Questionnaire survey histology

Countries

Japan

Contacts

Public ContactTakeshi Nagata

Hamamatsu University school of medicine Plastic and reconstructive surgery

nagatake@hama-med.ac.jp053-435-2502

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026