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, Tadahiko Masaki, Eiji Sunami, Norihiko Ohura, Koji Teruya, Ken Eto, Keijiro Nozawa, Kazuhiro Sakamoto, Kimihiko Funahashi, Koichiro Kojima, Mayu Goto, Yasuo Nagashima, Yoko Saito, Masaya Kawai, Shihori Takebe, Akiko Egawa, Mitsuko Tanba, Kazue Ishikawa, Hiroyoshi Matsuoka, Tadahiko Masaki, Eiji Sunami, Norihiko Ohura, Koji Teruya, Ken Eto, Keijiro Nozawa, Kazuhiro Sakamoto, Kimihiko Funahashi

Abstract

Background: The 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.

Methods: The 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.

Results: In 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%).

Conclusions: The 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 registration: UMIN Clinical Trials Registry; UMIN000032174 (10/04/2018).

Keywords: Ileostomy closure; Negative pressure wound therapy; Phase II trial; Purse-string suture; Randomized controlled trial; Surgical site infection; Wound healing.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Purse-string suture. The performed method of PSS is presented. We used 1 PDS Plus as the suture and a 5-mL syringe was used to create an open wound. PSS purse-string suture
Fig. 2
Fig. 2
Wound treatment in Groups B and C. The wound management method using the PICO system for PSS is presented. The foam inserted when applying PICO was removed on POD 3. PSS purse-string suture, POD postoperative day
Fig. 3
Fig. 3
Measurement of wound volume. The wound volume was measured by injecting saline solution into the wound using a 1-mL syringe
Fig. 4
Fig. 4
Study flowchart. The 30 patients enrolled were divided into the groups
Fig. 5
Fig. 5
Study protocol. The treatment schedule for each of the three groups
Fig. 6
Fig. 6
CONSORT flow chart. The process, by which patients assigned to each group, was analyzed
Fig. 7
Fig. 7
Reduction rate. The comparison of the wound reduction rate in the postoperative course of each group is presented. There was a significant difference in the reduction rate between Groups A and C at PODs 7 and 10
Fig. 8
Fig. 8
Wound healing period. The comparison of the healing time between the groups is presented. No significant differences were observed

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