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THE EFFECT OF POSTOPERATIVE NEGATIVE PRESSURE WOUND THERAPY ON THE INCIDENCE WOUND DEHISCENCE IN LOW AND HIGH-RISK BREASTRECONSTRUCTION PATIENTS.

“Closed Incision Negative Pressure Therapy (ciNPT) reduces abdominal donor site surgical wound dehiscence in Deep Internal Epigastric Perforator (DIEP) flap breast reconstructions: DEhiscence PREvention Study II (DEPRES II) - a Randomized Clinical Trial”

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28913
Enrollment
80
Registered
2017-02-24
Start date
2017-11-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

wound healing, wound dehiscence, wound rupture, burst abdomen, negative pressure wound therapy, postoperative treatment, surgical wounds

Interventions

In the experimental group Prevena™ Incision Management System is applicated in clean closed surgical incision. In the controlgroup stery strips and foam are applicated in clean closed surgical incis

Sponsors

Department of Plastic and Reconstructive Surgery, Radboud University Medical Center (Radboudumc) Geert Grooteplein-Zuid 10 Nijmegen, The Netherlands www.radboudumc.nl
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: o > 18 years o signed informed consent Risk factors for wound dehiscence: o Diabetes Mellitus (type 1 or type 2) o BMI more than 30 o Smoking o Radio therapy o COPD Undergoing one of those elective plastic surgeries: o breast reconstruction with transabdominal incision (DIEP flap) o pressure ulcers surgery (rotation flap) o VY- plastic o TFL-flap tensor fascia lata)

Exclusion criteria

Exclusion criteria: fistula in incision area

Design outcomes

Primary

MeasureTime frame
presence of wound dehiscence presence of wound infection

Secondary

MeasureTime frame
pain elasticity of the skin (skin tension)

Contacts

Public ContactEmmy Muller-Sloof

Radboud University Medical Center

Emmy.Muller-Sloof@Radboudumc.nlM 00 31 (0) 611090325

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)