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

Published

URL related to results and publications

https://onlinelibrary.wiley.com/doi/10.1002/lary.32210, https://aao-hnsfjournals.onlinelibrary.wiley

Number of participants that the trial has enrolled

129

Results

Donor
Non-ciNPT use was associated with a higher relative risk of complications compared with ciNPT use.

Recipient
No significant differences were found between groups across complication categories.

Results date posted

2026

Year

06

Month

30

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2025

Year

04

Month

25

Day

Baseline Characteristics

Donor
Patient characteristics included age, sex, body mass index (BMI), diabetes mellitus, chronic obstructive pulmonary disease, steroid/immunosuppressant use, smoking, preoperative chemotherapy, American Society of Anesthesiologists physical status (ASA-PS), preoperative serum albumin level, preoperative serum hemoglobin level, operating time, blood loss, blood transfusion, lesion site, flap, drain placement, perioperative prophylactic antibiotic, and ciNPT use. The closed suction drain and bag were BLAKE Drains and J-VAC Reservoirs (Ethicon, New Jersey, USA). The CiNPT system used in this study was the PREVENA Incision Management System.

Recipient
Patient characteristics included age, sex, body mass index (BMI), hypertension (HT), diabetes mellitus (DM), chronic obstructive pulmonary disease (COPD), steroid/immunosuppressant use, smoking, preoperative chemotherapy, preoperative radiotherapy, history of head and neck surgery, neck dissection, bony reconstruction, American Society of Anesthesiologists physical status (ASA-PS), preoperative serum albumin level, preoperative serum hemoglobin level, operating time, blood loss, blood transfusion, lesion site, pT and pN category, surgical wound classification, flap type, perioperative prophylactic antibiotic, duration of prophylactic antibiotic administration and duration of intensive care unit stay.

Participant flow

Donor
Of the 204 eligible cases where flap harvest sites were examined, we excluded the following: 30 cases with closed flap harvest sites using skin grafts or flaps, 15 cases of free jejunal flap transfer, 14 cases of latissimus dorsi musculocutaneous flap or scapular osteocutaneous flap transfer, and 60 cases where ciNPT instruments other than PREVENA Incision Management System were used. As a result, 85 flap harvest sites were included in the analysis (n = 46 [54.1%] utilized ciNPT and n = 39 [45.9%] did not)

Recipient
Of the 73 eligible cases where flap harvest sites were examined, we excluded the following: 17 cases with maxillary lesions, 3 cases with external auditory canal lesions, 7 cases with parotid gland lesions, and 2 cases of pharyngocutaneous fistulae following total laryngectomy. As a result, 44 cases were included in the analysis, of whom 21 (47.7%) utilized ciNPT.

Adverse events

Outcome measures

Donor
The primary endpoint was the occurrence of postoperative complications at the flap harvest site with primary closure within 30 days after surgery. Postoperative complications at the flap harvest site with primary closure were defined as wound dehiscence, skin necrosis, surgical site infection (SSI), postoperative hematoma, and seroma (Clavien-Dindo (CD) classification grade I or higher). The criteria of the Centers for Disease Control and Prevention (CDC) were adopted for SSI. The definitions of hematoma and lymphorrhea in this study were those diagnosed by properties of fluids when there was swelling and puncture or opening of the wound or when there was wound dehiscence; we did not include cases in which a fluid accumulation was found incidentally on CT but was followed up without puncture or opening because it was not clinically problematic. Secondary endpoints were the types of complications and the CD classification for each complication.

Recipient
The primary endpoint was the occurrence of postoperative complications in the head and neck within 30 days after surgery. Postoperative complications in the head and neck were defined as skin necrosis, surgical site infection (SSI), hematoma, lymphorrhea, anastomotic leakage, flap vascular compromise (Clavien-Dindo (CD) classification grade IIIa or higher). The criteria of the Centers for Disease Control and Prevention (CDC) were adopted for SSI. The definitions of hematoma and lymphorrhea in this study were those diagnosed by properties of fluids when there was swelling and puncture or opening the wound or when there was wound dehiscence. Flap monitoring was performed using clinical assessment of the skin paddle, including visual inspection and pinprick testing. No handheld or implantable Doppler devices were used. The same monitoring protocol was applied consistently to both the ciNPT and non-ciNPT groups. The secondary endpoints were the occurrence of distinct types of complications including skin necrosis, surgical site infection (SSI), hematoma, lymphorrhea, anastomotic leakage, and flap vascular compromise.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

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

2026

Year

06

Month

30

Day

Link to view the page

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