Condition category
Infections and Infestations
Date applied
30/10/2011
Date assigned
20/01/2012
Last edited
17/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Lay summary under review 3

Trial website

http://www.stomavac.darmzentrum-bwkulm.de

Contact information

Type

Scientific

Primary contact

Dr Stefan Dr. Benesch

ORCID ID

Contact details

Colorectal Cancer Center
Department of General
Visceral and Thoracic Surgery
Armed Forces Hospital
Ulm
89081
Germany
+49 (0)731 1710 1238
sbenesch@me.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Reducing the surgical site infection rate after loop coloSTOMy reversal by Application of Vacuum Assisted delayed wound Closure: a randomized controlled trial

Acronym

STOMAVAC

Study hypothesis

To investigate the conditioning effect of VAC to colostomy wounds prior to delayed primary closure. A reduction of the substantial high rate of superficial and deep surgical site infection rates of 30% is expected.

Ethics approval

Not provided at time of registration

Study design

Single-center stratified parallel-group randomized controlled clinical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Surgical site infection rate, negative-pressure wound therapy

Intervention

After hospital admission, an x-ray series of both limbs of the stoma is taken with radiopaque material. Where required, further cardiopulmonary diagnostic measures are done the day before surgery.
The colon cleansing is done by drinking 90 ml (two bottles) of a phospho-soda solution together with at least of two litres of water. At the morning of the surgery day a colonoscopy of both the afferent and efferent limb of the large bowel is to be done. To enhance the adherence to the protocol and to avoid clustering effects all operations will either be performed or assisted by one of two surgeons who are colorectal surgeons and have the same surgical expertise. Antibiotic prophylaxis is given one hour preoperatively (tazobactam + piperacillin/metronidazol). First, a circular incision is done directly along the stoma edges. After that, the stoma is mobilized until the fascia of the externus muscle is achieved. Then, using scissors, the stoma will be mobilized out of the abdominal wall. Approx. 3 cm oral and aboral the stoma opening the colon is tunneled and cut with a linear stapler. This is followed by a centrally directed V-shaped incision and dissection of the mesocolon. The blood vessels are each supplied with a ligature. Epiploic appendices located opposite to the mesocolon are removed over a distance of 6cm at both ends. The staple lines are now opened on the corner and the two limbs are laid side by side in parallel, so that now a functional end-to-end stapled anastomosis can be created. Finally, the mesocolonic slit is closed with a continuous suture. Then the anastomosis is shifted back into the abdominal cavity. An intraperitoneal drainage is not inserted. The peritoneum is closed with continuous stitches. Now, a swab is taken from the subcutaneous tissue for microbiological examination. Then the abdominal wall and subcutaneous tissue is rinsed with Octenisept® solution and after that rinsed with saline solution. This is followed by a glove change. The fasicas are the closured with continous stitches using a PDS-loop.

The further procedures depend on the randomization that was performed on the day before surgery:

Intervention group
A VAC sponge is prepared and fitted into the subcutaneous wound. The wound edges are cleaned, then the wound is sealed with a continuous suction of 125 mmHg for 48 hours. 48 hours after surgery the VAC-system is removed, a swab is taken and without flushing it the subcutaneous tissue is sutured. This is followed by an infiltration of the wound edges with Naropin® and skin closure using interrupted stitches. At this time any adverse effects of VAC therapy are documented.

Control group
The subcutaneous tissue is closed with sutures. This is followed by an infiltration of the wound edges with Naropin and skin closure using interrupted stitches. The postoperative management regarding mobilization and return to solid food follows the fast track principle in both groups. Starting with the second postoperative day after definitive wound closure daily dressing changes are done. The wound status is assessed daily at the ward by the respective senior attending on the basis of the Centre for Disease Control (CDC) criteria for defining a superficial or deep wound infection. After taking swabs the wound is cleaned, disinfected and covered with a plaster. For documentation purposes, additionally a macro photo of the wound is made. With unremarkable course, returned peristalsis and healed anastomosis in the control group the patients can be discharged at 8th postoperative day and in the intervention group at 6th postoperative day after definitive wound closure. So for both groups the same length of minimum treatment time is guaranteed. At the day of discharge a wound swab is taken. Additional discharge criteria are normal wound conditions, completion of mobilization and ingestion of food and declined inflammation parameters. If a superficial wound infection occurs without affection of the subcutaneous tissue the stitches of the ​​skin are removed and a swab is taken for microbiological examination. This is followed by a conservative regimen. Once the out-patient care is guaranteed by a professional nurse wound, the patient may be discharged from inpatient treatment. If the subcutaneous tissue is also affected, a surgical treatment like that in deep SSI follows except re-opening of the fascia and muscle layer. If a deep wound infection is present, the wound in the operating room is fully opened. A swab is taken, then the wound is debrided, flushed and vacuum sealed after closure of the peritoneum. This is followed by several seal changes until the wound appears clean and the last swab is sterile. Then either a secondary wound closure will follow or the wound is left open for secondary wound closure. Afterwards the patient can be discharged. On suspicion of an anastomotic leak a CT scan of the abdomen is performed with transrectal radiopaque material filling. If the suspicion is confirmed, a revision surgery is performed with resection of the anastomosis. Depending on the intraabdominal situation a new anastomosis and a protective loop ileostoma or a double-barrel stoma is created. With discharging the patients from hospitalization they receive an appointment for outpatient follow-up at the 10th-12th postoperative day. At this time all stitches are removed and a swab is taken. A further follow-up examination follows at day 30 after first surgery. The quality of life-score is evaluated using SF-36 at the day of admission and day 30.

Intervention type

Drug

Phase

Not Applicable

Drug names

Metronidazol, piperacillin, tazobactam

Primary outcome measures

The rate of superficial and deep surgical site infections (SSIs) after ostomy takedown (in a period of 30 days postoperative after colostomy reversal) based on the CDC criteria for definition of a wound infection

Secondary outcome measures

The influence of the particular treatment on the quality of life (assessed with SF-36), and to evaluate factors, which might influence the rate of SSIs

Overall trial start date

01/12/2011

Overall trial end date

01/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Eligible participants are all adults aged 18 or over
2. Loop colostomy to be reversed
3. Signed informed consent for participating in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Patients with inflammatory bowel diseases
2. Persons who received systemic steroids within the last year

Recruitment start date

01/12/2011

Recruitment end date

01/12/2014

Locations

Countries of recruitment

Germany

Trial participating centre

Armed Forces Hospital
Ulm
89081
Germany

Sponsor information

Organisation

Armed Forces Hospital (Germany)

Sponsor details

Oberer Eselsberg 40
Ulm
89081
Germany

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

German Army (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes