UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan

Condition

Head and neck reconstruction

Classification by specialty

Plastic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to clarify the efficacy of ciNPT (Closed Incision Negative Pressure Therapy) by comparing the group that used ciNPT with the group that did not in terms of postoperative wound complications in head and neck reconstruction.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

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.

Key secondary outcomes

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key 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.

Target sample size

170

Name of lead principal investigator

1st name	Haruyuki
Middle name
Last name	Hirayama

Organization

The Jikei University School of Medicine

Division name

Department of Plastic and Reconstructive Surgery

Zip code

105-8461

Address

3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan

TEL

+81-334331111

Email

haruyuki.hirayama@jikei.ac.jp

Name of contact person

1st name	Haruyuki
Middle name
Last name	Hirayama

Organization

The Jikei University School of Medicine

Division name

Department of Plastic and Reconstructive Surgery

Zip code

105-8461

Address

3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan

TEL

+81-334331111

Homepage URL

https://jikei.bvits.com/rinri/publish_document.aspx?ID=6185

Email

haruyuki.hirayama@jikei.ac.jp

Institute

The Jikei University School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Jikei University School of Medicine, research ethics committee

Address

3-25-8 Nishi-shimbashi, Minato-ku, Tokyo 105-8461, Japan

Tel

+81-334331111

Email

rinri@jikei.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京慈恵会医科大学附属病院

Date of disclosure of the study information

2024

Year

11

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2024

Year

09

Month

10

Day

Date of IRB

2024

Year

09

Month

09

Day

Anticipated trial start date

2024

Year

11

Month

01

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study is a single-center observational study aimed at investigating the reduction of postoperative wound complications in patients who have undergone head and neck reconstruction surgery. It compares two groups: a group treated with ciNPT (closed incision Negative Pressure Therapy, a recently developed therapy covered by insurance and used at our institution) and a conventional dressing group (control group). For cases before the ethics committee approval date, retrospective data will be collected, while cases after the approval date will be prospectively observed.

To test the primary hypothesis, the study will examine the incidence, types, and severity of postoperative wound complications between the ciNPT group and the conventional dressing group, followed by statistical analysis. For retrospective subjects, data will be collected separately for both the ciNPT and conventional dressing groups. For prospective subjects, if informed consent is obtained, ciNPT will be applied immediately after surgical wound closure (including skin grafts and local flaps) and will be continued until postoperative day 7, unless wound complications, such as signs of infection, are suspected. The incidence, types, and severity of postoperative wound complications will be evaluated on day 30 after surgery. The ciNPT treatment will use the 3MTM PrevenaTM Incision Management System.

Registered date

2024

Year

11

Month

06

Day

Last modified on

2024

Year

11

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064067