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Study on the Efficacy of ciNPT (Closed Incision Negative Pressure Therapy) in Head and Neck Reconstruction

Study on the Efficacy of ciNPT (Closed Incision Negative Pressure Therapy) in Head and Neck Reconstruction - Study on the Efficacy of ciNPT (Closed Incision Negative Pressure Therapy) in Head and Neck Reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000056066
Enrollment
170
Registered
2024-11-06
Start date
2024-11-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Head and neck reconstruction

Interventions

None listed

Sponsors

The Jikei University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The study will include individuals who meet all of the following inclusion criteria: 1. Patients who have undergone head and neck reconstruction surgery at this facility. 2. Age: 18 years or older. 3. Gender: No restrictions. 4. For patients undergoing surgery after the date of ethics committee approval, written informed consent must be obtained from the individual after receiving a full explanation of the study, demonstrating thorough understanding, and being able to attend follow-up visits according to the study schedule. 5. For patients who had surgery before the date of ethics committee approval, those who did not express a refusal to participate following the disclosure of the study through an opt-out process.

Exclusion criteria

Exclusion criteria: Individuals who meet any of the following exclusion criteria will be excluded from the study: 1. Those whom the principal investigator or researchers deem inappropriate for participation in this study. 2. Those who have expressed a refusal to participate in the study.

Design outcomes

Primary

MeasureTime frame
The number of postoperative wound complications at 30 days post-surgery. Postoperative wound complications are defined as any of the following: Clavien-Dindo (CD) classification grade 1 or higher complications, wound dehiscence, skin necrosis, partial or complete skin graft necrosis, partial or complete flap necrosis, surgical site infection, postoperative bleeding/hematoma, and seroma/lymphorrhea.

Secondary

MeasureTime frame
1. Presence of wound dehiscence 2. Need for reoperation due to wound dehiscence 3. Clavien-Dindo classification of wound dehiscence 4. Presence of skin necrosis 5. Need for reoperation due to skin necrosis 6. Clavien-Dindo classification of skin necrosis 7. Skin graft take status (full take, partial necrosis, complete necrosis) 8. Need for reoperation due to skin graft necrosis 9. Clavien-Dindo classification of skin graft necrosis 10. Flap take status (full take, partial necrosis, complete necrosis) 11. Need for reoperation due to flap necrosis 12. Clavien-Dindo classification of flap necrosis 13. Presence of surgical site infection 14. Clavien-Dindo classification of surgical site infection 15. Presence of postoperative bleeding or hematoma 16. Clavien-Dindo classification of postoperative bleeding or hematoma 17. Presence of seroma or lymphorrhea 18. Clavien-Dindo classification of seroma or lymphorrhea 19. Length of hospital stay

Countries

Japan

Contacts

Public ContactHaruyuki Hirayama

The Jikei University School of Medicine Department of Plastic and Reconstructive Surgery

haruyuki.hirayama@jikei.ac.jp+81-334331111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026