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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00514566
Other study ID # ChristianMCLudhiana
Secondary ID
Status Terminated
Phase N/A
First received August 8, 2007
Last updated August 8, 2007
Start date October 2004
Est. completion date April 2006

Study information

Verified date August 2007
Source Christian Medical College and Hospital, Ludhiana, India
Contact n/a
Is FDA regulated No
Health authority India: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Within the last decade the customary trend of using non absorbable sutures has changed, with numerous studies and meta-analyses advocating the use of slowly absorbable sutures, claiming comparable wound strength with significantly lower incidence of wound complications. It was the objective of this randomized clinical trial to compare two universally accepted suture materials, the non-absorbable Nylon and the slowly absorbable Polydioxanone for midline abdominal closure in the Indian context.


Description:

64 patients undergoing midline laparotomy were allocated, using block randomization, to mass closure of the abdominal wall with continuous polyamide (34 patients) or continuous polydioxanone (30 patients).

There was an alarmingly higher incidence of wound dehiscence in the PDS group requiring secondary suturing (Nylon 0; PDS 5). Mid-way through the trial, an interim analysis was performed which revealed an unacceptably high incidence of wound dehiscence in the PDS group. This necessitated a premature curtailment of the study. There was, however, a statistically significantly higher incidence of scar pain in the Nylon group (Nylon 9; PDS 1).

There is a need for a study with larger series, and PDS as a choice of suture for midline wound closure cannot be recommended.


Recruitment information / eligibility

Status Terminated
Enrollment 64
Est. completion date April 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria:

- All patients above 12 years of age undergoing midline abdominal fascial closure using a continuous technique in the Department of Surgery, Christian Medical College and Hospital

Exclusion Criteria:

- All patients under 12 years of age

- Gynaecological operations

- Abdominal wall hernia repair

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Suture for midline abdominal closure
closure with Polyamide or Polydioxanone

Locations

Country Name City State
India Christian Medical College and Hospital Ludhiana Punjab

Sponsors (1)

Lead Sponsor Collaborator
Christian Medical College and Hospital, Ludhiana, India

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wound Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain 2 years
Secondary Factors independent of suture materials responsible for wound complications such as age, gender, type of surgery, degree of contamination, surgeon, and presence of a stoma 2 years
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