Evidence map›Paper›PMID 34963451›Full record

Trial reportBMC surgery2021

Effectiveness of negative pressure wound therapy for the wound of ileostomy closure: a multicenter, phase II randomized controlled trial.

Koichiro Kojima, Mayu Goto, Yasuo Nagashima, Yoko Saito, Masaya Kawai, Shihori Takebe, Akiko Egawa, Mitsuko Tanba, Kazue Ishikawa, Hiroyoshi Matsuoka and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC surgery, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05474911 (RANDOMIZED COMPARATIVE CLINICAL STUDY BETWEEN TWO TREATMENT STRATEGIES IN PATIENTS WITH PILONIDAL SINUS), which is not on this map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
1.7field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05474911 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Randomized comparative clinical study between two treatment strategies in patients with pilonidal sinus: conventional care versus negative pressure therapy.

TypeinterventionalSponsorSebastiano BiondoRan2022 to 2023Enrolled94ConditionsPilonidal Sinus, Wound HealArmsNegative pressure therapy, Conventional wound care
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Article
  6. Article
  7. Review
  8. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 6 institutions in 1 country.

Koichiro KojimaDepartment of Surgery, Kyorin University School of Medicine, 6-20-2, Shinkawa, Mitaka city, Tokyo, 181-8611, Japan. k-kojikoji@ks.kyorin-u.ac.jp.
Mayu GotoDepartment of General and Gastroenterological Surgery, Toho University Omori Medical Center, Tokyo, Japan.
Yasuo NagashimaDepartment of General and Gastroenterological Surgery, Toho University Omori Medical Center, Tokyo, Japan.
Yoko SaitoWOCN, Department of Nursing, Toho University Omori Medical Center, Tokyo, Japan.
Masaya KawaiDepartment of Coloproctological Surgery, Juntendo University School of Medicine, Tokyo, Japan.
Shihori TakebeWOCN, Department of Nursing, Juntendo University School of Medicine, Tokyo, Japan.
Akiko EgawaWOCN, Department of Nursing, The Jikei University School of Medicine, Tokyo, Japan.
Mitsuko TanbaWOCN, Department of Nursing, Kyorin University School of Medicine, Tokyo, Japan.
Kazue IshikawaWOCN, Department of Nursing, Teikyo University School of Medicine, Tokyo, Japan.
Hiroyoshi MatsuokaDepartment of Paramedics, Kyorin University Faculty of Health Sciences, Tokyo, Japan.
Tadahiko MasakiDepartment of Surgery, Kyorin University School of Medicine, 6-20-2, Shinkawa, Mitaka city, Tokyo, 181-8611, Japan.
Eiji SunamiDepartment of Surgery, Kyorin University School of Medicine, 6-20-2, Shinkawa, Mitaka city, Tokyo, 181-8611, Japan.
Norihiko OhuraDepartment of Plastic, Reconstructive and Aesthetic Surgery, Kyorin University School of Medicine, Tokyo, Japan.
Koji TeruyaDepartment of Health & Welfare, Kyorin University Faculty of Health Sciences, Tokyo, Japan.
Ken EtoDepartment of Surgery, The Jikei University School of Medicine, Tokyo, Japan.
Keijiro NozawaDepartment of Surgery, Teikyo University School of Medicine, Tokyo, Japan.
Kazuhiro SakamotoDepartment of Coloproctological Surgery, Juntendo University School of Medicine, Tokyo, Japan.
Kimihiko FunahashiDepartment of General and Gastroenterological Surgery, Toho University Omori Medical Center, Tokyo, Japan.
Kyorin University · JPJuntendo University · JPToho University Omori Medical Center · JPJikei University School of Medicine · JPTeikyo University · JPToho University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe American Society of Surgery and American Society for Surgical Infections issued guidelines for surgical site infections (SSIs) in December 2016. These guidelines recommend a purse-string suture (PSS) for stoma closure as it facilitates granulation and enables open wound drainage. This study investigated the effect of using negative pressure wound therapy (NPWT) along with standard PSS and aimed to determine the optimal period of NPWT use.

methodsThe patients were divided into three groups as follows: Group A, postoperative wound management alone with gauze exchange as the representative of conventional PSS; Group B, the performed management was similar to that of Group A plus NPWT for 1 week; and Group C, the performed management was similar to that of Group A plus NPWT for 2 weeks. Regarding objective measures, the wound reduction rate was the primary outcome, and the incidence of SSIs, length of hospital stay, and wound healing duration were the secondary outcomes.

resultsIn total, 30 patients (male: 18, female: 12) were enrolled. The average age was 63 (range: 43-84) years. The wound reduction rate was significantly higher in Group B than in Group A on postoperative days (PODs) 7 (66.1 vs. 48.4%, p = 0.049) and 10 (78.6 vs. 58.2%, p = 0.011), whereas no significant difference was observed on POD 14. Compared with Group A, Group C (POD 7: 65.9%, POD 10: 69.2%) showed an increase in the wound reduction rate on POD 7, although the difference was not significant (p = 0.075). SSIs were observed in Groups B (n = 2) and C (n = 2) (20%) but not in Group A (0%).

conclusionsThe most effective duration of NPWT use for ileostomy closure with PSS in terms of the maximum wound reduction rate was from PODs 3 to 10. However, NPWT did not shorten the wound healing duration. NPWT may reduce the wound size but should be used with precautions for SSIs. The small sample size (30 cases), the use of only one type of NPWT system, and the fact that wound assessment was subjective and not blinded were the limitations of this study. Further studies are needed to confirm our findings.

trial registrationUMIN Clinical Trials Registry; UMIN000032174 (10/04/2018).

Indexed as

Negative-Pressure Wound TherapyAdultAgedAged, 80 and overDrainageFemaleHumansIleostomyMaleMiddle AgedSurgical Wound InfectionWound HealingIleostomy closureNegative pressure wound therapyPhase II trialPurse-string sutureRandomized controlled trialSurgical site infectionWound healing

Identifiers

PMID34963451
PMCPMC8713411
OpenAlexW4200138641

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.