Pico ™ single use negative pressure wound therapy system compared to standard wound care with endoprosthetic care of the hip

Pico ™ single use negative pressure wound therapy system compared to standard wound care with endoprosthetic care of the hip - HTEP-PICO

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00014259

Enrollment

400

Registered

2020-05-06

Start date

2018-11-30

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

T84.5 T89.03

Interventions

Group 1: In this group, the wound is treated with the PICO vacuum wound dressing after the hip operation. During the clinical stay after the operation, the dressing is examined in daily visits until d

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: -BMI> 30 -Primary care with a hip endoprosthesis -male and female patients over the age of 18

Exclusion criteria

Exclusion criteria: known diseases affecting immunology

Design outcomes

Primary

Measure	Time frame
The revision rate within the first four postoperative weeks between treatment with standard therapy (OPsite patch) and study therapy (PICO) should be examined. During the clinical stay after the operation, the dressing is examined every day until discharge. Wound healing is clinically observed and recorded. In addition to the laboratory chemical infection parameters (CRP, leukocyte count), clinical signs of infection such as increased secretion are recorded. If there is a wound healing disorder or infection, wound management and microbiology is included in the subsequent treatment and a treatment strategy is developed and initiated together. In the event of a physiological wound healing process and other freedom from symptoms, the patients are discharged as usual. Four weeks postoperatively, participants are contacted once by telephone and asked about the current status of wound healing.	—

Measure

Time frame

The revision rate within the first four postoperative weeks between treatment with standard therapy (OPsite patch) and study therapy (PICO) should be examined. During the clinical stay after the operation, the dressing is examined every day until discharge. Wound healing is clinically observed and recorded. In addition to the laboratory chemical infection parameters (CRP, leukocyte count), clinical signs of infection such as increased secretion are recorded. If there is a wound healing disorder or infection, wound management and microbiology is included in the subsequent treatment and a treatment strategy is developed and initiated together. In the event of a physiological wound healing process and other freedom from symptoms, the patients are discharged as usual. Four weeks postoperatively, participants are contacted once by telephone and asked about the current status of wound healing.

—

Secondary

Measure	Time frame
Logistic regression for the outcome "Revision" is planned as a further secondary analysis.	—

Countries

Germany

Contacts

Public ContactYvonne Noll

Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift, Leitung Klinisches Studienmanagement

yvonne.noll@diakovere.de0511-5354-649

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026