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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05199974
Other study ID # soh-med-21-12-08
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date May 30, 2022

Study information

Verified date June 2022
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The occurrence of sudden disruption of abdominal wall laparotomy wound is a major disaster and a major psychological trauma to the patient . Acute wound dehiscence is defined as postoperative separation of the abdominal musculoaponeurotic layers within 30 days after operation. Many risk factors were incriminated in causation of burst abdomen including malnutrition, anemia, hypo-proteinemia, pre and post-operative prolonged steroid therapy, peritonitis, malignancy, jaundice, uremia and post-operative abdominal distension or cough. Wound dehiscence may be related to the technique of closure of abdomen and the sutures used. Numerous studies have been conducted evaluating many closure techniques and suture materials. There is a number of studies evaluating various closure techniques and suture materials to prevent wound dehiscence following emergency midline laparotomy. In developing countries such as India, most patients operated as an emergency develop wound dehiscence such as they have prolonged intraperitoneal sepsis and malnutrition. The current opinion for closure of a midline incision is mass closure with non-absorbable or slowly absorbable suture . Tension is distributed evenly along the length of the wound. The standard technique for abdominal closure is 'mass closure' (closing all layers of the abdominal wall, excluding the skin), usually with nonabsorbable sutures, although 'slow-resorbing' sutures such as polydioxanone (PDS) are also widely used . In Smead-Jones method of closure tension between two loops is distributed in such a way that the fascial edges are well approximated. Originally described method was interrupted. Continuous method has advantage of being faster and has less risk of wound dehiscence due to dynamic distribution of increased tension in postoperative period due to see-saw effect. We proposed modification of original Smead-Jones technique by doing it in continuous manner to increase the benefits and found this method to be fast, cost-effective, equally effective in controlling wound infection and better than interrupted technique to prevent wound dehiscence.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 30, 2022
Est. primary completion date May 30, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Any patient has risk factor for weak scar who underwent emergency laparotomy through midline incision . Exclusion Criteria: - Patients who had previous laparotomy. - patients who underwent laparotomy through incisions other than midline incisions.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Midline abdominal closure
Abdominal Closure in Emergency Midline Laparotomy

Locations

Country Name City State
Egypt Sohag University Hospital Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Begum B, Zaman R, Ahmed M, Ali S. Burst abdomen-A preventable morbidity. Mymensingh Med J. 2008 Jan;17(1):63-6. — View Citation

Rucinski J, Margolis M, Panagopoulos G, Wise L. Closure of the abdominal midline fascia: meta-analysis delineates the optimal technique. Am Surg. 2001 May;67(5):421-6. — View Citation

Sajid MS, Parampalli U, Baig MK, McFall MR. A systematic review on the effectiveness of slowly-absorbable versus non-absorbable sutures for abdominal fascial closure following laparotomy. Int J Surg. 2011;9(8):615-25. doi: 10.1016/j.ijsu.2011.09.006. Epub 2011 Oct 30. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of burst abdomen post operative Number of burst abdomen postoperative in emergency midline laparotomy 1 month
See also
  Status Clinical Trial Phase
Recruiting NCT05424484 - Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia Occurrence N/A
Active, not recruiting NCT04311788 - Preemer Trial - Prophylactic Mesh Versus no Mesh in the Midline Emergency Laparotomy Closure for Prevention of Incisional Hernia: a Multi Center, Double-blind, Randomized Controlled Trial N/A